CANCER CARE OUTCOMES RESEARCH AND SURVEILLANCE CONSORTIUM
											 
Release Date:  August 24, 2000

RFA:  CA-01-013 - (Reissued as RFA-CA-09-503) 
 
National Cancer Institute
 
Letter of Intent Receipt Date:  October 15, 2000
Application Receipt Date:       January 24, 2001  
 
PURPOSE 

The Division of Cancer Control and Population Sciences (DCCPS), National 
Cancer Institute (NCI), invites applications from domestic institutions for 
cooperative agreements to support a new collaborative research consortium that 
would conduct Cancer Care Outcomes Research and Surveillance (CanCORS).  
Research institutions are invited to apply for primary data collection and 
research site (PDCR) awards that would support the conduct of prospective 
studies in newly diagnosed cohorts of lung and colorectal cancer patients.  
These prospective studies will collect information about medical care 
practices used to manage patients over the course of their disease, various 
outcomes associated with these practices, and information about patient and 
provider behaviors and perceptions.  This information will be collected in 
order to address three goals reflecting major NCI research priorities: 

1) Enhance monitoring and understanding of the processes of cancer care and 
the patient-centered factors influencing prognosis in population-based cohorts 
of patients.
2) Establish a system for examining the relationship between the processes of 
care and clinical and patient-centered outcomes, with emphasis on measuring 
the dissemination of state-of-the-science interventions and their association 
with better quality outcomes in the general population of cancer patients. 
3) Examine disparities in the receipt of state-of-the-science cancer care and 
factors that contribute to disparities in outcomes, such as health-related 
quality of life (QOL), and identify ways to lessen those disparities.

This RFA is the first major step by NCI to support the development of a system 
for obtaining details about cancer care beyond the initial diagnosis and 
limited treatment data that are now routinely collected in high quality 
population-based cancer registries.  This research will help build the 
information base needed for measuring and improving the quality of cancer care 
in the US. 

This RFA cooperative agreement will fund individual grantees who will be 
formed into the CanCORS Consortium whose purpose will be to collaboratively 
collect and analyze process-outcome relationships in patients newly diagnosed 
with lung or colorectal cancer. Applicants must propose specific research 
hypotheses to serve as the scientific foundation of this data collection 
system.  In addition, separate applications are invited to support a CanCORS 
Statistical Coordinating Center (SCC).  The primary objectives of the SCC will 
be to develop and support the collection of standardized, core data across 
individual research sites, and to serve as the central repository for the 
analysis of pooled data.  

NCI has established a CanCORS website which includes answers to frequently 
asked questions to further assist potential applicants: 
http://www-dccps.ims.nci.nih.gov/ARP/cancors.html.

RESEARCH OBJECTIVES
 
Background
 
The overall goal of the national cancer research program is to reduce 
mortality and morbidity from cancer in the US population.  Current 
surveillance systems, including the Surveillance, Epidemiology, and End 
Results (SEER) Program established in 1973, track incidence, survival, and 
mortality rates in parts of the population.  Specific measures of the burden 
of cancer in terms of process and outcomes of care were identified in the 
 Measures of Progress Against Cancer  report to the U.S. Senate Appropriations 
Committee in 1990 (see ref #1). In that report, an expert panel recommended 
that the NCI systematically track patterns of care and assess services 
delivered to cancer patients.  The NCI responded to this recommendation by 
conducting SEER-based, cross-sectional studies of practice patterns, 
establishing the SEER-Medicare data base, and sponsoring other special 
targeted surveys.  External review groups and committees, most recently the 
Institute of Medicine’s (IOM) National Cancer Policy Board (NCPB) (see ref 
#2), the Cancer Surveillance Research Implementation Group 
(http://dccps.nci.nih.gov/DCCPS/SIG/), and NCI’s Progress Review Groups, 
including the Colorectal Cancer Progress Review Group 
(http://osp.nci.nih.gov/Prg_assess/PRG/CPRG/default.htm have all urged the 
NCI and other research agencies to expand cancer care surveillance research 
beyond these efforts, and to include the study of the process and outcomes of 
cancer care in national, longitudinal, population-based patient cohorts.  One 
example of such studies is the Prostate Cancer Outcomes Study (PCOS) 
(http://www-dccps.ims.nci.nih.gov/ARP/PCOS/index.html).

One of the NCPB’s specific recommendations was to  support national studies of 
newly diagnosed cancer patients using data sufficiently detailed to assess 
patterns of care and their relationship to valued outcomes  (Recommendation 
8).   A second was to investigate why specific segments of the population are 
not receiving quality cancer care, and to explore ways of removing access 
barriers (Recommendation 10). The earlier Cancer Surveillance Research 
Implementation Plan (prepared by the Surveillance Implementation Group, NCI, 
March 1999) also noted this suggestion, under priority area #1,  suggesting 
the  collection of data on patterns of care, health status, morbidity, and 
quality of life as well as cohort studies of newly diagnosed registered cancer 
patients for the purpose of documenting levels and trends in these 
parameters .  This RFA is part of the NCI’s response to these recommendations, 
as embodied in the NCI Director’s remarks to the IOM on 5 October 1999.  It is 
also consistent with the NCI Director’s two challenge areas regarding quality 
of care and health disparities, and is consistent with the mission of the 
DCCPS to monitor and report on diverse measures of the burden of cancer in the 
population.  

This expansion of research on cancer care delivery is complementary to the 
goals of the Department of Health and Human Services Quality Improvement 
Initiative and also to the trans-departmental Quality Interagency Coordination 
Task Force (QuIC).  The vehicle for coordinating these efforts in cancer care 
is the NCI-chaired Quality of Cancer Care Committee, a transagency working 
group that includes representatives from other Federal agencies involved in 
the delivery, payment, or regulation of cancer care. 

The long-term goal of the research to be supported by this RFA is to provide a 
stronger, more representative empirical evidence base of process-outcome 
linkages in the delivery of care used to treat, monitor, and palliate cancer 
patients. The goal is not to promulgate guidelines or recommendations by a 
specific organization or institution, or to compare the patterns of care in 
the community setting against an external "standard" suggested by a specific 
guideline. However, the extent to which different guidelines are used and the 
effect of their use on patient outcomes is an example of an association that 
can be examined in response to this RFA. 

A central focus of NCI’s outcomes research program is on developing methods 
for defining, measuring, and reporting on the quality of cancer care. 
Currently, the NCI and other Federal and private research organizations 
support cross-sectional studies describing cancer practice patterns that rely 
primarily on cancer registries that are based on hospital records or linked 
data bases such as SEER-Medicare.  The CanCORS initiative represents the next 
important and logical step in furthering the research agenda on quality of 
cancer care by identifying process and outcome measures that can eventually be 
incorporated into a national data system for monitoring and improving that 
care.  Studies supported by this RFA will permit much more in-depth 
assessments of cancer care and its relationship to outcomes in diverse 
populations and delivery settings than any prior systematic research efforts 
in this field.  Such large scale studies have yet to be supported because of 
their size and complexity.  Over time, the knowledge gained from CanCORS will 
help to identify the core elements of a national, shared data system on 
quality of care that can be used by patients, providers, researchers, and 
health plans.  

Definitions

AWARDEE:  The institution to which the UO1 grant is awarded, including both 
PDCR sites and the SCC.  

NCI PROGRAM DIRECTOR:  Scientist administrator from the NCI extramural staff, 
the Program Director will not only provide normal stewardship for the UO1 
grants awarded under this RFA, but will also be involved in the scientific 
coordination and collaboration within the CanCORS Consortium and will 
coordinate and facilitate interaction among the awardees.

PRINCIPAL INVESTIGATOR (PI):  The investigator who is designated by the 
applicant organization to direct the project to be supported by the UO1 grant.  
The PI will assume the responsibility and accountability to the applicant 
organization officials and to the NCI for performance and proper conduct of 
the research supported by the UO1 mechanism.  Each institution may have more 
than one CanCORS PI, and a single person may be the PI for applications that 
include both lung and colorectal cancer. 

NCI SCIENTIFIC STAFF:  Scientific staff from NCI’s extramural and intramural 
programs called upon to provide their expertise to the CanCORS Consortium 
efforts.

CanCORS CONSORTIUM:   The newly formed entity created under this RFA by 
joining together individual awardees for the purpose of conducting 
collaborative research on process-outcome relationships in a longitudinal 
cohort of lung and colorectal cancer patients. 

PRIMARY DATA COLLECTION AND RESEARCH (PDCR) SITE:  An awardee, consisting of 
an institution or organization which is responsible for primary data 
collection of core processes and outcomes of cancer care, reporting core data 
to the central SCC, and performing statistical analysis of pooled data.  PDCR 
sites may have their own data collection infrastructure or may partner with 
other data collection entities.

STATISTICAL COORDINATING CENTER (SCC):   Single awardee responsible for data 
transfer from PDCR sites, storage, documentation, and formatting for pooled 
statistical analysis by investigators from PDCR sites or from the SCC.  Will 
also support development of standardized data collection at participating PDCR 
sites and advancement of study design and statistical techniques for the 
Consortium as a whole. 

CORE DATA ELEMENTS:   Variables pertaining to processes of care (or 
interventions to manage, treat, and palliate cancer patients) and outcomes of 
care (including traditional endpoints such as recurrence and mortality, as 
well as patient-oriented outcomes such as quality of life, satisfaction, and 
economic burden) to be collected by all participating PDCR sites for pooled 
analysis.

SPECIAL RESEARCH PROJECTS:  Smaller ancillary studies proposed by individual 
applicants that complement the collection and/or the analysis and 
interpretation of core data.  Each PDCS applicant must propose at least one 
but no more than two such projects, and SCC applicants must propose at least 
one but no more than three special projects.

CanCORS STEERING COMMITTEE (CSC):   A committee consisting of the PI’s from 
each of the PDCR sites, the PI of the SCC, the NCI Program Director, and one 
person from the NCI scientific staff as designated by the NCI Program 
Director.  A PDCR site may include an additional representative on the CSC if 
that site is participating in data collection for both lung and colorectal 
cancer. The Chair of the CSC will be one of the PI’s as selected by the CSC.  
The CSC can admit additional non-federal non-voting members as they deem 
necessary.  The CSC will provide overall scientific direction for the CanCORS 
Consortium and establish and oversee policies and procedures.  

DATA STANDARDS COMMITTEE (DSC):  Formed by the CSC, the DSC will be 
responsible for defining the core data elements selected by the CSC or its 
designees.  The DSC  will be responsible for assisting and coordinating the 
collection and reporting of standardized, quality data by all participating 
sites to the SCC.  The DSC will be chaired by the PI of the SCC, and will 
include other members named by the CSC.  Non-federal persons from outside the 
Consortium may be added to advise the DSC, if such expertise is not available 
from within the Consortium.

PARTICIPATION MONITORING COMMITTEE (PMC):  Formed by the CSC, the PMC will be 
responsible for monitoring the adherence of all research sites to the uniform 
study protocol established for collection of core data elements, and 
monitoring patient response rates, attrition, and cooperation of local 
providers with data collection activities.  The PMC members from within the 
Consortium will be named by the CSC. Non-federal persons from outside the 
Consortium may be added to advise the PMC, if such expertise is not available 
from within the Consortium.

CanCORS WORKING GROUP (CWG):  Named by the CSC, this group will consist of 
persons from outside the CanCORS Consortium who will provide advice (of its 
individual members) to the CSC regarding overall strategies, study designs, 
analysis plans, and results.

Scope 

The study of lung and colorectal cancer practice patterns and associated 
outcomes can be achieved by means of a coordinated, prospective study 
conducted by 5-12 PDCR sites with a central SCC for data coordination and 
reporting.  The PDCR sites will enroll and collect core data on a total of 
approximately 6,000 newly diagnosed cases per cancer.  Enrolling a large 
sample of patients for longitudinal studies will permit assessments of 
process-outcome relationships across diverse population sub-groups and health 
care delivery systems.  Applicants may participate in the study of one or both 
cancers.  Each PDCR site will be required to collect standardized, core 
variables pertaining to cancer-specific practices used to treat, monitor, and 
palliate cancer patients, and patient outcomes associated with these 
practices. Other core data elements will be likely confounding factors, such 
as comorbidity, socio-demographic, and economic variables.  All core data will 
be reported to the central SCC for pooled analysis to be carried out 
collaboratively by all participating investigators.  Final selection of core 
variables to be collected across participating research sites will be jointly 
determined by the CanCORS Steering Committee (CSC) during the first year of 
the project.  In addition to information about cancer care and outcomes, 
applicants are invited to propose collection of other factors potentially 
associated with long-term prognosis, such as lifestyle factors.  Such 
information may be proposed as part of the core study, or as a special 
research project to be conducted in selected sub-samples of enrolled patients.  
Given the disproportionately high cancer burden borne by some population 
subgroups, emphasis should be placed on assessing reasons for disparities in 
processes and outcomes of cancer across age, gender, socioeconomic and racial-
ethnic groups.  Research questions on this topic should focus not only on 
describing differences in care, but on investigating the underlying reasons 
for such variations related to patient characteristics such as age and 
comorbidity, patient preferences, provider characteristics, and health system 
organization and reimbursement attributes.

The development of large, observational studies in community settings serves 
as an important adjunct to the NCI’s clinical research program.  The types of 
studies to be carried out will complement what is learned from randomized 
clinical trials by assessing the dissemination and impact of new knowledge in 
the population. There exists a wide spectrum of evidence about the efficacy of 
cancer treatments, ranging from treatments known to be efficacious based on 
evidence from Phase III randomized clinical trials (RCT), to interventions for 
which there is no clear consensus about the efficacy of various treatment 
options.  For such interventions, there are numerous other factors that may 
dictate patterns of practice.  For the sake of more clearly describing the 
objectives of this RFA, these two categories are discussed separately below. 

A.  Treatments with proven efficacy from RCTs 


The main focus of studies for such treatments will be to assess the 
dissemination of evidence-based care to the larger, general population.  The 
assessment should include cross-sectional descriptions of variations in 
practice patterns in diverse care settings, and comparisons of cancer outcomes 
in RCTs with outcomes observed in non-protocol settings.  Dissemination of 
RCT-proven interventions to the general population may be limited because 
providers may not quickly adopt new treatments on the one hand, or patients in 
community practices may not be directly comparable to participants in well-
controlled RCTs.  Thus, it is important to measure outcomes of RCT-proven 
therapies in population-based clinical settings.  An improved understanding of 
the many factors that encourage or inhibit patient access to efficacious 
interventions is a necessary first step in the overall research agenda aimed 
at increasing the proportion of cancer patients in the US who receive high 
quality cancer care.  Applicants will also be asked to address provider 
issues.  For example, physician attitudes and knowledge, and health care 
delivery system factors might  affect the dissemination of cancer treatments.   
Access to specialists versus generalists may also influence processes and 
outcomes that could be assessed across different types of health care delivery 
organizations.  Applicants should consider the assessment of multiple factors 
that may be associated with poor dissemination of  RCT-proven cancer-related 
practices among vulnerable populations defined by age, socioeconomic status, 
and some racial/ethnic groups who traditionally experience higher mortality 
from cancer.

B.  Treatments with unproven mortality benefits or therapeutic options not yet 
compared in RCTs

As in the case of  proven  therapies for cancer based on RCTs, it is first 
necessary to characterize practice patterns where there is no clear consensus 
about  best  practices and the underlying reasons for variations across 
populations, including patient factors, preferences, and provider factors.  
The main purpose of measuring outcomes will differ in the case of unproven 
interventions, since there is no standard of care based on RCT evidence 
against which to compare community-based outcomes.  Information to be obtained 
through linking process with outcomes in observational studies can serve at 
least two important purposes.  First, the association between processes and 
outcomes of cancer care in situations of uncertain efficacy will enhance 
clinical decision making by giving both patients and clinicians an expanded 
evidence base upon which to choose among competing therapeutic strategies.  
Observational studies cannot definitively establish the superiority of one 
treatment versus another in terms of curative potential.  However, information 
about other outcomes important to patients, such as side-effects and QOL, can 
be obtained in diverse patients and delivery settings to provide a more 
complete picture of possible outcomes from specific treatments.  Additionally, 
observational studies in large, representative cohorts can help develop 
hypotheses to be tested in new clinical trials by raising questions about the 
cost-benefit tradeoffs of therapies that are currently delivered in everyday, 
 real-world  health care settings.  

Another research objective is to measure the prevalence of long-term 
functional limitations due to cancer or sequelae of treatments, as well as the 
effectiveness of palliative treatments for these sequelae or disease-specific 
functional limitations.  Applicants should describe the potential significance 
of information as the foundation for new research directions focusing on the 
development of cost-effective behavioral and health services interventions 
designed to alleviate cancer morbidity in the population. However, 
intervention research per se will not be supported under this RFA. 

Research Objectives

PDCR site applicants must specify research hypotheses relating to lung or 
colorectal cancer practices and associated outcomes. Specific hypotheses to be 
proposed by applicants should address the following five general research 
objectives of this RFA:

1. Cross-sectional analysis of practice patterns for cancer patients according 
to multiple patient clinical and sociodemographic characteristics;  assessment 
of other determinants of access to cancer care services according to patient, 
health care delivery system, and physician characteristics; evaluation of 
awareness of cancer clinical trials and CancerNet.

2. Analysis of underlying reasons for variations in cancer practices and 
outcomes among vulnerable populations, defined by age, socioeconomic status 
and racial-ethnic identification. 

3. Longitudinal assessments of outcomes, and how outcomes are mediated by 
variations in the processes and structure of care over the course of the 
disease, i.e., during initial, continuing, or terminal phases of cancer care.

4. Identification of patient, provider, and health system factors influencing 
the dissemination and effectiveness of interventions that have been 
demonstrated in randomized studies to reduce cancer-specific mortality or 
morbidity, or improve health-related QOL.

5. Assessments of the contribution of modifiable lifestyle factors on 
prognosis and health outcomes.  Such information may be collected on specific 
sub-samples for whom such information is most relevant.

PDCR site applicants are encouraged to incorporate methodological studies to 
identify, develop, and validate process and outcome measures most useful for 
clinical decision making, as well as to develop more efficient, standardized, 
automated data collection methods on processes and outcomes of cancer care. 
Applicants are encouraged to consider novel ways of prospectively collecting 
information on processes of care, for example, through the use of emerging 
clinical informatics systems.

PDCR site applicants are invited to suggest sampling designs that permit 
oversampling of specific sub-groups defined by sociodemographic or clinical 
criteria to address high priority areas of interest.  In order to track 
temporal trends in care, or to track newly emerging technologies that arise 
during the award period, applicants may propose the identification of new, 
additional incident cohorts of lung or colorectal cancer patients to be added 
during the term of the award and supported through administrative supplements.  

Core Data Elements

For the purpose of assessing cancer care delivery in the general community 
setting, awardees must reach agreement on the core measures and variables to 
be collected across all primary data collection sites.  PDCR site applicants 
must propose candidate core data elements based on specified research 
hypotheses.  This serves as the beginning of the process of selecting final 
core measures.  The final selection of core variables will be made during the 
first year of the project by the CSC (see more on the structure and function 
of the CSC under Terms and Conditions).  Specific instruments or 
questionnaires to measure core elements will be selected by the CSC, or 
through other procedures established by the CSC.  For example, a designated 
sub-committee may be charged with responsibility for instrument selection or 
development of original instruments as required. 

The NCI’s CanCORS webpage (http://www-dccps.ims.nci.nih.gov/ARP/cancors.html) 
includes an outline of general core process and outcome measures that serves 
as a reference point for prospective applicants to encourage some commonality 
among the individual applicants.  However, applicants are not restricted to 
these core issues or questions.  The website also contains a separate link 
describing examples of disease-specific questions relating to processes of 
care for lung and colorectal cancer that span the continuum of care spanning 
from diagnosis through terminal care.  These suggested measures serve as the 
foundation for core data elements to be collected by all Consortium research 
sites.  After awards are made applicants must be willing to work with other 
Consortium sites to select and define these core measures.  Applicants should 
review these outlines in preparation of their applications.

Study Protocol

A crucial element of the collection of core data in the CanCORS Consortium 
will be the study protocol specifying the precise methods and timing for 
collecting core data uniformly. Although applicants are required to propose a 
protocol for data collection specific to to their own site in applications, 
the common protocol to be used by all research sites will be finalized by the 
CSC or its designees during the initial year of the project.  For the purpose 
of helping applicants estimate the resources necessary to collect core data, 
it is anticipated that there will be 2 waves of a mixed mode (self-
administered mail initially) patient survey, performed at baseline 
(approximately 4-6 months post-diagnosis) and repeated approximately 1-2 years 
later.  Provisions and procedures for interviewing surrogates or next-of-kin 
for deceased patients should be described in applications.  A modest payment 
for the study participants, such as $20-50, may be included to enhance 
participation and compensate participants for their time.  Research 
applications will also require a baseline medical record review, involving 
abstraction of all sources of cancer-related providers of care within the 
first 1-2 years of diagnosis, and a re-abstraction of a sample of cases (such 
as 20-40%) 1-2 years after the baseline medical record reviews.  Additional 
contacts to enhance accrual and retention, such as informational or 
promotional materials, with patients or providers, should also be described in 
applications. 

Composition of PDCR Sites

This RFA invites applications from research organizations, including those 
within academic institutions, cancer centers, state agencies, professional or 
managed care organizations.  Participants in the Consortium may also include 
member institutions of Cooperative Groups or Community Clinical Oncology 
Program (CCOPs), large health care delivery organizations or professional 
societies, providing such organizations can demonstrate inclusion of a 
heterogeneous population of cancer patients with respect to socio-demographic 
characteristics and diverse health care systems with respect to organization 
and reimbursement characteristics.  Organizations that lack access to such 
population-based patient or health care system samples may propose the 
development of innovative data collection systems for ensuring the necessary 
surveillance coverage of populations and health care practices appropriate to 
the research supported by this RFA.  Coverage may also be accomplished through 
partnerships with data collection entities, such as population-based cancer 
registries, or other organizations with the capability of developing 
innovative health care data collection systems. 

Ideally, the composition of each PDCR site will be interdisciplinary, with 
expertise in clinical sciences, psychosocial and behavioral research, 
epidemiology, health services research, and biostatistics, at a minimum.  
Establishing local collaborations with relevant patient and provider partners, 
such as representatives from major professional societies, may be helpful in 
facilitating access to primary data sources essential for measuring community 
practice patterns and outcomes. Participation of patient advocacy groups is 
also strongly encouraged.

Applications for PDCR sites will be strengthened by the participation of 
individuals with clinical expertise in the organ system under study, and 
individuals with statistical expertise in the analysis of observational data 
on health care services and outcomes.

PDCR site applications must include documentation of prior experience in the 
collection of data regarding studies of cancer practice patterns and long term 
cancer outcomes.  Such experience may include identification of incident 
patient populations within defined areas, abstraction of baseline clinical 
data from medical records, active follow up for vital status, patient surveys, 
and close ties with local providers.  Experience with previous epidemiologic 
or health services research studies that involve similar activities to those 
required by this RFA should be documented as part of the demonstration of 
capability

Approximate Timetable    
 
During year 1, each participating research site and the SCC will work 
collaboratively to select core data elements, finalize the study protocol for 
collection of core elements, obtain IRB approvals, and develop and test data 
collection and reporting procedures.  Contacts with local provider groups and 
patient advocates will be made to facilitate cooperation of cancer patients 
with the research effort.  Enrollment and initial data collection efforts will 
occur in years 2-3, including initial patient surveys and obtaining patient 
consent for review of medical records.  Medical record abstraction to obtain 
records-based core variables will occur during years 3-4.  Depending on the 
research hypotheses to be addressed as part of the core studies, additional 
surveys and secondary reviews of medical records may occur in years 4-5.  

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and non-profit 
organizations, public and private, such as universities, colleges, hospitals, 
laboratories, units of State and Local governments, and eligible agencies of 
the Federal Government.  Applications from minority individuals, women, and 
persons with disabilities, are encouraged to apply as principal investigators.  
Foreign applicants are not eligible to apply.

SPECIAL REQUIREMENTS

Terms and Conditions of Award

The following terms and conditions will be incorporated into the award 
statement and provided to the Principal Investigator(s) as well as the 
institutional offical at the time of award.  The reporting requirements, the 
plans for NCI’s involvement in the Cancer Care Outcomes Research and 
Surveillance (CanCORS) Consortium and the requirements for coordination among 
investigators from the individual sites are described.  

Under the cooperative agreement, a partnership will exist between the 
recipient of the award and the NCI, with assistance from the NCI in carrying 
out the planned activity.  The following terms and conditions pertaining to 
the scope and nature of the interaction between the NCI and the investigators 
will be incorporated in the Notice of Grant Award.  These terms are in 
addition to, and not in lieu of, otherwise applicable OMB administrative 
guidelines; HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, 
and other HHS, PHS, and NIH Grant Administration policy statements.

The inability of an awardee to meet the performance requirements set forth in 
the Terms and Conditions of Award, or significant changes in the level of 
performance, may result in an adjustment of funding, withholding of support, 
suspension or termination of award.

1.   Awardee Rights and Responsibilities

A.  All awardees

All awardees must join the CanCORS Consortium and cooperate fully in the 
planning and implementation of collaborative projects designed to address 
research objectives set forth in the RFA.  Within this framework, the awardees 
will have primary and lead responsibility for the project as a whole, 
including research design and protocol development.  Data from the 
collaborative projects will be pooled for joint analysis, interpretation and 
publication by Consortium investigators in accord with policies and procedures 
established by the CanCORS Steering Committee (CSC). Awardees are obligated to 
adhere to joint decisions for publications and research direction decided on 
by the CSC.

All awardees are required to attend semi-annual meetings to discuss and review 
scientific and technical aspects of implementation, and analysis and 
presentation of data results.  At least two investigators (including the PI), 
but no more than four investigators, from each awardee must attend these 
meetings. The first meeting will be convened by the NCI Program Director and 
held shortly after initiation of the award. At the initial meeting, Principal 
Investigators from each of the award recipients will specify the structure and 
function of a cooperative organizational unit, referred to as the CSC. 

In order to address the wide range of substantive and methodological issues 
that may arise during the course of implementation of collaborative protocols, 
awardees will agree to attend up to two additional small working group 
meetings per year to facilitate progress on specific analyses, if deemed 
necessary by the CSC.

Awardees are required to provide quarterly reports on progress of special 
research projects to the CSC, who may then distribute information to other 
CanCORS investigators as appropriate.

B. Primary Data Collection and Research (PDCR) sites

PDCR site awardee responsibilities are to:

1.  Enroll a minimum number of patients (1,000 per cancer) in order to achieve 
the overall sample size objectives of the Consortium (6,000 per cancer).  
Enrollment is defined as obtaining consent for performing inpatient and 
outpatient medical record reviews from patients or their next-of-kin over the 
2-year accrual period.
2.  Agree to participate in the Participation Monitoring Committee (PMC) to 
assist in the specification of performance targets in terms of initial 
response rates and attrition.  These targets will be used by the CSC and PMC 
as part of their role of ensuring that PDCR sites achieve and maintain high 
rates of respondent participation.
3.  Obtain access to three sources of information vital to core data 
collection: pathology facilities, cancer patients or their next-of-kin, and 
institutions and providers who possess records about the patient and the care 
they received.
4.  Adopt a common data collection protocol and use standardized data 
collection instruments approved by the CSC to ensure uniform procedures across 
individual site awardees.  
5.  Accept and implement the common processes and procedures approved by the 
CSC or its designees for transmitting core data to the Statistical 
Coordinating Center (SCC).  Awardees must submit core data in timely manner to 
the SCC to ensure such data is available for pooled analyses within the time 
frame established by the CSC.
6.   Assume lead responsibility for the study design, planning, completion of 
statistical analysis and interpretation of pooled data. 
7.  Demonstrate a willingness to interact effectively with the SCC, discuss 
their capability to participate in a consortium of research groups, and state 
their willingness to help develop and follow the common protocol that will be 
used to collect core variables.
8.  Conduct at least one, and not more than two, special research project(s) 
that complement core data collection or analysis, but that are separate from 
the participation in the collection of core data elements.  

C. Statistical Coordinating Center (SCC)

The SCC awardee must also participate actively in all meetings of the CanCORS 
Consortium and provide scientific, statistical, and technical input into 
discussions of pooled and collaborative research projects. 

Specifically, the SCC awardee responsibilities are to:
1. Maintain data comparability processes to be developed by the CanCORS 
investigators, and improve these processes where needed.
2. Serve as the central repository for pooled data by maintaining confidential 
and secure mechanisms for transmitting electronic files for core data elements 
to the SCC.
3.   Provide centralized training to patient survey staff and medical record 
abstraction personnel from the PDCR sites.
4.  Examine and report on the quality of submitted data for the purpose of 
pooled data analysis.
5.  Provide data files in ready-to-analyze format (for example, in formats 
recognized by common statistical packages such as SAS) to the PDCR site 
investigator(s) responsible for the specific pooled study.  
6.  Provide the research expertise and collaboration to PDCR site 
investigators on complex statistical issues for analysis of pooled data.
7.  Assume leadership and coordination of regular conference calls of the CSC, 
and maintaining good communications among all awardees during the term of the 
project.
8.  Conduct at least one, and not more than three, special research project(s) 
that complement core data collection or analysis.

2.  NCI Staff Responsibilities

The NCI Program Director will be responsible for normal stewardship of this 
award, and will also have substantial scientific/programmatic involvement 
during the conduct of this activity, through technical assistance, advice, and 
coordination above and beyond normal program stewardship for grants. The NCI 
Program Director will  monitor and review the activities of the awardees for 
relevance to the objectives of the RFA and other programmatic considerations.

The NCI Program Director will serve as a member of the CSC, and will designate 
an additional NCI scientific staff person to serve on the CSC.

The NCI Program Director will convene the first of the semi-annual meetings 
for award recipients to join the CanCORS Consortium. Throughout the term of 
the project, the NCI Program Director will continue to facilitate and 
coordinate interactions among the CanCORS awardees to ensure the standardized 
collection of all core data elements selected by the CSC.

The NCI will have access to all data generated under this award consistent 
with current HHS, PHS, and NIH policies.  Periodically, the NCI Program 
Director or designee will review data management and analysis procedures.  

The NCI Program Director, or designated NCI scientific staff, will provide 
information to the awardees about a wide range of data sources and methods 
used in other studies to complement the design of collaborative projects.  The 
NCI Program Director will call upon other NCI scientific staff as needed to 
provide advice on specific scientific and technical issues.

In addition to normally prescribed duties of program and grants staff, an 
on-site program review at each awardee site will occur as early as 12 months, 
but no later than 24 months, after award.   The program review will be 
conducted to evaluate progress of the site in the recruitment of research 
subjects and collection of core data elements.  At least four months prior to 
these on-site program reviews, specific performance criteria will be provided 
to sites by the NCI Program Director.  These performance criteria will 
include:  minimum target levels of enrollment, survey response rates, access 
to medical records for reviews, implementation of quality control for 
collection, storage, and transmittal to the SCC, and study drop-out rates. The 
minimum accrual targets will be initially developed and proposed by the PMC 
(without NCI staff involvement in development of review criteria) and approved 
by the NCI Program Director.

3.  Collaborative Responsibilities

The CanCORS Steering Committee (CSC) is a committee consisting of the PI’s 
from each of the PDCR sites, the PI of the SCC, the NCI Program Director, and 
one person from the NCI scientific staff as designated by the NCI Program 
Director.  The NCI will have one vote.  A PDCR site may include an additional 
representative on the CSC if that site is participating in data collection for 
both lung and colorectal cancer.  The Chair of the CSC will be one of the PI’s 
as selected by the CSC.  The CSC can admit additional non-federal non-voting 
members as they deem necessary.  The CSC will:

1.  Be the ultimate decision making body for the CanCORS Consortium, unless a 
disagreement is brought to arbitration.
2.  Establish administrative procedures (i.e., meeting dates, guidelines for 
reporting, etc.) and methods by which all scientific/analytic requirements of 
the RFA will be met.
3.  Establish or approve collaborative study protocols, core data elements, 
and instruments to collect core data within a timeframe to be established at 
the first CanCORS meeting.
4.  Approve protocols for special research projects occurring only at one PDCR 
site or collaborative projects at multiple PDCR sites.  The CSC may designate 
this function to the PMC in order to ensure minimal respondent burden 
regarding collection of core data elements. 
5.  Develop policies and procedures regarding publication or presentation of 
data.
6.  Meet separately during the course of the semi-annual CanCORS meetings.  It 
will also meet by conference call at least twice between the semi-annual 
meetings. 
7.  Define and establish separate cancer-site specific working groups (for 
lung and colorectal cancers) if deemed necessary, who would report to the CSC.
8.   Establish a CanCORS Working Group (CWG) consisting of persons from 
outside the Consortium who will provide advice (of its individual members) to 
the CSC regarding overall strategies, study designs, analysis plans, and 
results.  The CWG will convene at least once each year.  The CSC will be 
responsible for naming members of the CWG and more specifically defining its 
role.
9.  Establish a Data Standards Committee (DSC), which will be responsible for 
defining the core data elements selected by the CSC or its designees.  The DSC  
will be responsible for assisting and coordinating the collection and 
reporting of standardized, quality data by all participating sites to the SCC.  
The DSC will be chaired by the PI of the SCC, and will include other members 
named by the CSC.  Non-federal persons from outside the Consortium may be 
added to advise the DSC, if such expertise is not available from within the 
Consortium.
10.  Establish a Participation Monitoring Committee, which will be responsible 
for monitoring the adherence of all research sites to the uniform study 
protocol established for collection of core data elements, and monitoring 
patient response rates, attrition, and cooperation of local providers with 
data collection activities.  The PMC members from within the Consortium or 
from among NCI staff will be named by the CSC. Non-federal persons from 
outside the Consortium may be added to advise the PMC, if such expertise is 
not available from within the Consortium. The PMC will identify the most 
successful protocols for ensuring high participation and low attrition rates, 
review data on participation and attrition rates as summarized by the SCC, and 
recommend changes in protocols at PDCR sites if high participation or low 
attrition rates are not maintained. The non-NCI members of the PMC will also 
develop performance criteria measures (for example, regarding patient 
enrollment and retention rates) for approval by the NCI Program Director to be 
used in conducting on-site program reviews of the individual awardees.  These 
criteria will be developed within 8 months of the initial award. 

The inability of an awardee to meet the performance requirements set forth in 
these Terms and Conditions of Award in the RFA, or significant changes in the 
level of performance, may result in an adjustment of funding, withholding of 
support, suspension or termination of the award.

4.  Arbitration Process

Any disagreement that may arise on scientific/programmatic matters (within the 
scope of the award) between award recipients and the NCI may be brought to 
arbitration.  NCI will establish an arbitration process when a mutually 
acceptable agreement cannot be obtained between the awardee and the NCI 
Program Director.  An arbitration panel (with appropriate expertise) composed 
of one member selected by the awardees, one NCI nominee, and a third member 
chosen by the other two members will be formed to review the NCI decision and 
recommend a course of action to the Director, NCI.  These special arbitration 
procedures in no way affect the awardee's right to appeal an adverse action in 
accordance with PHS regulations 42 CFR Part 50, Subpart D, and DHHS 
regulations 45 CFR Part 16. 

MECHANISM OF SUPPORT

The administrative and funding instrument to be used for this program will be 
a cooperative agreement (U01), an "assistance" mechanism (rather than an 
"acquisition" mechanism), in which substantial NIH scientific and/or 
programmatic involvement with the awardee is anticipated during performance of 
the activity.  Under the cooperative agreement, the NIH purpose is to support 
and/or stimulate the recipient's activity by involvement in and otherwise 
working jointly with the award recipient in a partner role, but it is not to 
assume direction, prime responsibility, or a dominant role in the activity.  
Consistent with this concept, the dominant role and prime responsibility for 
the activity resides with the awardees for the project as a whole, although 
specific tasks and activities in carrying out the studies will be shared among 
the awardees and the NCI scientific staff.

The total project period for applications submitted in response to the present 
RFA may not exceed 5 years.  The anticipated award date is September 1, 2001.    

Awards and level of support depend on receipt of a sufficient number of 
applications of high scientific merit.  Although this program is provided for 
in the financial plans of the NCI, awards pursuant to this RFA are contingent 
upon the availability of funds for this purpose. 
 
This RFA is a one-time solicitation. 

FUNDS AVAILABLE

The NCI intends to commit a total of approximately $6,000,000 in FY 2001 to 
fund 5 to 12 new  competing grants for PDCR sites plus one competing grant for 
the SCC in response to this RFA, and $8-8.5M in each of years 2-5.  The first 
year amount is smaller than years 2-5 because data collection activities are 
not anticipated to reach full implementation until year 2. Because the nature 
and scope of the research proposed may vary, it is anticipated that the size 
of each award will also vary.  

It is anticipated that one award for the SCC will be made for approximately 
$1,000,000 (including direct and Facilities and Administrative costs) per 
year, and up to 6 awards to PDCR sites for each cancer site (lung and 
colorectal) will be made for up to $600,000 (including direct and Facilities 
and Administrative costs) per year, averaged over the 5-year term of the 
award.  Because a single PDCR site may request additional funds if 
participating in data collection for both lung and colorectal cancer, the 
total number of PDCR site awards may be fewer than 12.  Special research 
projects should not exceed 20% of the total budget.

Although the financial plans of the NCI provide support for this program, 
awards pursuant to this RFA are contingent upon the availability of funds and 
the receipt of a sufficient number of meritorious applications.   At this 
time, it is not known if competing renewal applications will be accepted 
and/or if this RFA will be reissued.

INQUIRIES
 
Written and telephone inquiries concerning this RFA are encouraged.  The 
opportunity to clarify  any issues or questions from potential applicants is 
welcome. NCI has established a CanCORS website which includes answers to 
frequently asked questions (FAQs) to further assist potential applicants: 
http://www-dccps.ims.nci.nih.gov/ARP/cancors.html.

Direct inquiries regarding programmatic issues to:
 
Arnold L. Potosky, Ph.D.
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, Room 4005, MSC 7344
Bethesda, MD  20892-7344
Telephone:  (301) 496-5662
FAX:  (301) 435-3710
Email:  [email protected]

Direct inquiries regarding review issues to:

Ms. Toby Friedberg 
Referral Officer 
Division of Extramural Activities 
National Cancer Institute 
6116 Executive Blvd., Room 8109, MSC-8329
Rockville, MD 20852 (express courier)
Bethesda MD 20892-8329
Telephone (301) 496-3428
Fax: (301) 402-0275
Email: [email protected]

Direct inquiries regarding fiscal matters to: 
 
Brian Albertini 
Grants Administration Branch
National Cancer Institute 
6120 Executive Boulevard, Room 243, MSC 7150 
Bethesda, MD  20892-7150 
Rockville, MD 20852 (express courier)
Telephone:  (301) 496-7239 
Fax:  (301) 496-8601
Email:  [email protected]

LETTER OF INTENT
 
Prospective applicants are asked to submit, by October 15, 2000, a letter of 
intent that includes a descriptive title of the proposed research, name, 
address, and telephone number of the Principal Investigator, identities of 
other key personnel and participating institutions, and number and title of 
the RFA in response to which the application may be submitted. 
 
Although a letter of intent is not required, is not binding, and does not 
enter into the review of subsequent applications, the information allows NCI 
staff to estimate the potential review workload, and to plan the review. 
 
The letter of intent is to be sent to the program staff listed under INQUIRIES 
by the letter of intent receipt date listed. 

SCHEDULE
 
Letter of Intent Receipt:         October 15, 2000
Application Receipt Date:         January 24, 2001
Peer Review Date:                 May 2001
Review by NCAB Advisory Board:    August 2001
Earliest Anticipated Start Date:  September 2001

APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  Applications kits are available at most 
institutional offices of sponsored research and may be obtained from the 
Division of Extramural Outreach and Information Resources, National Institutes 
of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 
301/710-0267, E-mail: [email protected].  For those applicants with internet 
access, the 398 kit may be found at http://grants.nih.gov/grants/forms.htm.  

Specific Instructions for PDCR Site Applications (Core)

In proposing objectives, hypotheses, measures, and statistical analysis plans 
for the core component of the application, each PDCR applicant should assume 
it is part of the collaborative group of CanCORS awardees and, therefore, is 
making recommendations that would be considered for adoption by the group as a 
whole. For example, in the proposed analysis plan pertaining to core 
objectives, applicants should assume the availability of pooled core data to 
be collected by all PDCR site awardees. 

Applications to become a PDCR site within the CanCORS Consortium should 
include the following components:

1. A statement of objectives, and specific research hypotheses regarding 
process-outcome relationships for lung and/or colorectal cancer care.  
Proposed hypotheses should have associated proposed core measures, including 
important confounding factors such as comorbidity and sociodemographic 
characteristics, to be collected by all PDCR sites.  Background should 
describe the scientific relevance and the importance of proposed core measures 
for informing cancer care policies and/or clinical decision making.  Examples 
of general core measures, and suggested topics for disease-specific studies, 
are available at the CanCORS website 
http://www-dccps.ims.nci.nih.gov/ARP/cancors.html.  

2.   Description of population from which eligible cases will be ascertained, 
and any characteristics of that population regarding access to cancer care 
that may enhance or limit generalizability.  Applicants should provide 
evidence of socioeconomic diversity of sampled patients treated in diverse 
health care delivery settings.  The minimum number of patients for each cancer 
(lung and colorectal) to be enrolled is 1,000 (enrollment defined here as 
obtaining consent for performing inpatient and outpatient medical record 
reviews from patients or NOK) over a maximum 2-year accrual period.

3.   Plans and methods for recruitment and retention of research subjects 
including the qualifications of the organization(s) for collecting data, and a 
detailed plan for identifying, acquiring, and transmitting the core data to 
the SCC.  Applicants should also provide:
A. Evidence of ability to rapidly enroll newly diagnosed cases as part of 
epidemiologic or health services studies.  Applicants should propose 
procedures to achieve at least 90% case ascertainment (of all eligible 
cases) from pathology facilities serving their defined populations 
within a six month time period following initial diagnosis;
B. Methods to conduct mixed mode patient surveys (mailed with phone or in-
person follow-up);
C. Methods to obtain appropriate consent from patients for medical record 
reviews, and to obtain record reviews from all relevant providers 
associated with delivery of cancer-related health care over the course 
of the disease; 
D. Methods for conducting comprehensive follow up to measure practice 
patterns and outcomes in different phases of care including initial 
treatment, surveillance for recurrence/progression and secondary 
cancers, treatment for recurrence/progression, and end-of-life care.  
Special attention should be given to the problems of attrition common to 
all longitudinal studies, and methods for maintaining a high 
participation rate among cases and community physicians and other health 
care providers throughout the duration of the study;
E. Plans for obtaining cooperation of patients, next-of-kin, and  providers 
necessary for successful data collection efforts;
F. Proposed information technologies or information systems as part of 
efficiently collecting standardized, core data elements on cancer care 
practices and outcomes from diverse community medical settings.  
Applicants may propose development and testing of innovative systems.

4.  Description of quality control and assurance procedures for all phases of 
the research proposed from data collection, storage, transfer and analysis.  
In addition, it is essential that the level of data quality and quality 
control of the data source for the sampling frame, such as a cancer registry 
or other data system, be described.  For example, recent descriptions of data 
quality within cancer registries in North America have been developed by the 
North American Association of Central Cancer Registries (NAACCR).

5.   Plans for addressing the issue of patient confidentiality, including how 
the records of all research subjects will be protected.  The applicant must 
include evidence and knowledge of legal issues pertaining to the collection 
and analysis of data.  When relevant, specific state and/or federal laws and 
their impact on the project must be fully explained.

6.   A preliminary analysis plan and statistical methods for addressing 
proposed core research questions or objectives. Applicants are encouraged to 
propose innovative statistical methods regarding development of new core 
measures, assessment of patterns of care and associated outcomes in 
observational settings, and/or survey design.

7.   Demonstration of past experience and willingness to participate as a 
collaborating research partner in Consortium activities, including the 
collection of timely, consistent, standardized core data elements and 
reporting of all de-identified information to a central SCC for the purpose of 
supporting pooled analyses. 

Applications should be flexible enough to accommodate further refinement and 
integration with the other awardees for the same organ system.  Potential 
applicants at single research institutions may coordinate with each other to 
meet minimum accrual targets and may submit common applications. 

Applicants must include provisions for pilot core data collection during the 
first year of the award.  This will provide the opportunity to evaluate the 
data collection protocol and methods for data collection and for ensuring high 
response rates and gaining physician participation and access to patient 
medical records.  The pilot data collection effort may be conducted on small 
samples of approximately 30-75 patients.  Applicants are particularly 
encouraged in this phase of the project to develop and test innovative 
information technologies for standardized data collection from community 
medical practices, as part of collecting either core data or data for special 
research projects.  

The page limit for the core research plan component is 25 pages for applicants 
proposing one cancer, and 35 pages for applicants proposing to study both lung 
and colorectal cancers.  The research plan should address the specific 
application criteria above using the following topic headings:
1.  Research objectives and aims (separate for each cancer if applicable).
 2.  Background and significance (separate for each cancer if applicable).
 3.  Suggested core data elements.  This section should suggest and justify 
core measures to be collected to address research objectives, though specific 
instruments are not required since those must be selected and agreed upon 
during the first year of the project by consensus. 
 4.  Proposed methods for enrolling and maintaining follow up of study 
participants.
 5.  Data collection infrastructure including prior experience, and detailed 
methods for obtaining, managing, transmitting the core data elements.
 6.  Preliminary analysis plan with statistical methods for analysis of core 
research questions.

Special Research Projects (non-core studies)

Applicants must propose additional special research projects separate from the 
core data collection component.  These projects are smaller studies proposed 
by individual applicants that complement the collection and/or the analysis 
and interpretation of core data.  Such special studies may include selected 
samples of patients participating in the core study.  Each PDCR site applicant 
must submit at least one, and not more than two, research plan(s) for special 
research project(s), separate from the participation in the collection of core 
data elements to be described in the application.  There is an additional five 
page limit for each additional special research project.  Separate budgets 
should be presented for each non-core special research project.  

For example, applicants may wish to assess the processes of treatment decision 
making to better understand the interaction of patient, provider, and 
institutional factors that may explain reasons for poor dissemination of 
recommended therapies.  This applicant might propose an ancillary study to be 
conducted within a sub-sample of patients who are enrolled at the time of 
initial diagnosis, and could thus report directly on factors, including the 
provider and institutional influences, that affected their decision making.  
Other examples of special studies may include, but are not limited to:

1. Research on innovative technical approaches for routinely collecting 
information about cancer care and outcomes;
2. Studies of other factors beyond traditional medical care practices that may 
be associated with long-term prognosis, such as use of complementary 
medicines, or modifiable lifestyle factors such as diet, smoking, and physical 
activity;
3. Utilization of emerging new technologies to treat or manage lung and 
colorectal cancer patients;
4. The assessment of new prognostic biomarkers of long-term risk through 
collection of blood or tissue specimens;
5. Proposal of innovative statistical methods for analyzing observational 
data;
6. Surveys of physician knowledge, attitudes, and practices;  studies of 
health care delivery systems and their impact on cancer care practices.

The research plan for special studies is limited to 5 pages per project, and 
should use the following topic headings:
1.  Research objectives and aims
2.  Background and significance
3.  Research methods and design.  Include specific details on how the sample 
would be drawn from among participants in the core study. 
4.  Preliminary analysis plan with statistical methods proposed.

Specific Instructions for SCC Applications

A separate complete application is required from institutions applying to be 
the SCC for the CanCORS Consortium.  Applicants to the SCC component are NOT 
required to be a PDCR site within the Consortium, though applicants for PDCR 
sites may also submit an application to be the SCC.

The sources of data for this research effort are diverse and range from solo 
practitioners in rural settings to multi-specialty groups within large, 
structured managed care organizations in urban settings.  The complexity of 
integrating data from these multiple sources and the increasing use of 
computerized medical record systems for clinical care necessitates the 
development of novel data collection and editing systems.  Therefore, one key 
function of the SCC will be to develop automated systems to ensure high 
quality, efficient reporting of core data from individual PDCR sites to the 
SCC for eventual use in pooled analyses.  Another key function of the SCC will 
be to support and assist the PDCR sites in their development of standardized, 
automated data collection methods tailored to their local health care 
environments.  Support for standardization across PDCR site local data 
collection systems should help to ensure that core data elements are of 
uniform, high quality across all participating sites.  The SCC applicant must 
describe the approach to soliciting cooperation from the all participating 
PDCR sites and exercising appropriate leadership in matters of study design, 
data acquisition, management, and analysis.  

Applicants for the SCC should propose plans and methods with respect to data 
management and coordination activities, including:

1.  Plans for establishing and evaluating data collection and formatting 
procedures to create comparable data files for pooled core data.  The SCC 
applicant should demonstrate an understanding of how to create comparable data 
files from diverse sources and how to link the various subcategories of data 
being collected for this research effort. 
2.  Procedures and methods for documenting core data elements and survey 
questions that are likely to be included as core items in collaborative 
studies. (see examples at http://www-dccps.ims.nci.nih.gov/ARP/cancors.html.)
3.   Plans for working with primary data collection research sites to develop 
quality control procedures for data collection, storage and transmission of 
data to the SCC.  While primary data collection research sites are responsible 
for developing site-specific quality control procedures for data collection 
and storage at their own sites, the SCC will be responsible for working with 
all research sites to ensure that a standard of data quality is practiced at 
all sites.  The SCC will also be responsible for providing centralized 
training of survey staff and medical record abstraction personnel from the 
individual PDCR sites.
4.  Detailed procedures for individual research sites to transfer all core 
data to the SCC using file transfer protocols.  The SCC applicant should 
provide evidence of understanding and experience in creating a central data 
repository.
5.  Procedures to ensure data security, privacy and confidentiality in the  
transfer process and while the data resides at the SCC. The applicant must 
include evidence and knowledge of legal issues pertaining to the collection 
and analysis of data.  When relevant, specific state and/or federal laws and 
their impact on the project must be fully explained.
6.  Plans and procedures for coordinating and maintaining regular 
communications among all the PDCR sites on an ongoing basis.

In addition to its central role in moving the CanCORS Consortium towards 
comparable core data collection, the SCC is intended to accomplish several 
other research objectives with this initiative, particularly the support and 
advancement of statistical methodology for studies of process-outcome linkages 
in community cancer care.  Statistical analysis of pooled data is the joint 
responsibility of investigators from PDCR sites, with collaboration with the 
SCC as apppropriate.   However, the SCC applicant should demonstrate 
familiarity with key statistical concepts relating to the analysis of 
observational, population data, such as repeated measures analysis, missing 
data, hierarchical modeling, and variability across populations, facilities 
and providers. SCC applicants should discuss the development of an 
infrastructure for supporting and furthering the development of statistical 
methods in collaboration with statisticians at the primary data collection 
sites.

In applications, the components of the SCC’s role in facilitating pooled 
analysis should include:

1.  Plans for data management, including formatting, and documentation of core 
data elements using data dictionaries.
2.  Methods for reporting the status of data submitted for pooled data 
analysis in terms of completeness and utility for pooled analysis. 
3.  Plans for collaborating with research sites as appropriate to identify or 
develop statistical methods, and commitment to providing leadership in 
advancing statistical methodology.

The research plan pertaining to the SCC’s role in data coordination and 
management for the core study is limited to no more than 25 pages, and should 
use the following topic headings:
1.  Research objectives and aims
2.  Data management, training, and quality control
3.  Analysis and statistical methodology
4.  Communication
5.  Scientific leadership and dissemination

Each applicant to the SCC must submit at least one but not more than three 
separate research plan(s) for special research projects entailing data 
collection techniques, or advances in statistical methodology or measurement.  
There is an additional five page limit allowed to describe the research plans 
for each of these special projects. If several projects are proposed, separate 
budgets should be submitted for each one. 

The research plan for special studies should use the following topic headings:
1.  Research objectives and aims
2.  Background and significance
3.  Research methods and design.  Include specific details on how the sample 
would be drawn from among participants in the core study. 
4.  Preliminary analysis plan with statistical methods proposed.

General Instructions for All Applications

Because the Terms and Conditions of Award will be included in all awards 
issued as a result of this RFA, it is critical that each applicant include 
specific plans for responding to these terms.  Plans must describe how the 
applicant will comply with NCI staff involvement as well as how all the 
responsibilities of awardees will be fulfilled.

Each applicant must describe the proposed duties and attendant necessary 
qualifications required for all other proposed personnel, such as project 
managers, pathology coordinators, statisticians, data managers, computer 
programmers, and data entry clerks. Each applicant must have a defined space 
for administrative activities and administrative personnel which will serve as 
a focus for data management, quality control, and communication. 

Each applicant should budget for investigators to attend semi-annual meetings 
over the duration of the 5-year term.  In addition, each applicant should 
budget for hosting two meetings of the CanCORS Consortium investigators over 
the duration of the 5-year term.

A statement of commitment from each participating institution or organization 
and/or  documentation of collaborative arrangements must be provided.  

Multiple research affiliations and related funded research are permitted, 
provided they are not conflicting.  The affiliation agreements must state 
specifically how the problem of competing projects will be resolved.

The RFA label available in the PHS 398 (rev. 4/98) application form must be 
affixed to the bottom of the face page of the application. Type the RFA number 
on the label. Failure to use this label could result in delayed processing of 
the application such that it may not reach the review committee in time for 
review. In addition, the RFA title and number must be typed on line 2 of the 
face page of the application form and the YES box must be marked.

The sample RFA label available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to 
allow for this change. Please note this is in pdf format.
 
Submit a signed, typewritten original of the application, including the 
Checklist, and three signed photocopies, in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive
Room 1040 - MSC 7710
Bethesda, MD  20892-7710
(20817 for express service)
 
At the time of submission, two additional copies of the application must also 
be sent to:

Ms. Toby Friedberg 
Referral Officer 
Division of Extramural Activities 
National Cancer Institute 
6116 Executive Blvd., Room 8109, MSC-8329 
Rockville, MD 20852 (express courier)
Bethesda, MD 20892-8329

Applications must be received by January 24, 2001.  If an application is 
received after that date, it will be returned to the applicant without review.  
The Center for Scientific Review  (CSR) will not accept any application in 
response to this announcement that is essentially the same as one currently 
pending initial review, unless the applicant withdraws the pending 
application.  The CSR will not accept any application that is essentially the 
same as one already reviewed.  This does not preclude the submission of a 
substantial revision of an application already reviewed, but such an 
application must follow the guidance in the PHS Form 398 application 
instructions for the preparation of revised applications, including an 
introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by CSR and 
responsiveness by the National Cancer Institue.  Incomplete and/or non-
responsive applications will be returned to the applicant without further 
consideration.  

Applications that are complete and responsive to the RFA will be evaluated for 
scientific and technical merit by an appropriate peer review group convened by 
the Division of Extramural Activities of the National Cancer Institute in 
accordance with the review criteria stated below.  As part of the initial 
merit review,  all applications will receive a written critique and undergo a 
process in which only those applications deemed to have the highest scientific 
merit, generally the top half of the applications under review, will be 
discussed assigned a priority score, and receive a second level review by the 
National Cancer Advisory Board.

Review Criteria

The general criteria to be used in the evaluation of grant applications are 
listed below, followed by specific criteria for primary data collection sites 
and the SCC.
 
The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  The 
reviewers will comment on the following aspects of the application in their 
written critiques in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals.  Each of these 
criteria will be addressed and considered by the reviewers in assigning the 
overall score weighting them as appropriate for each application.  Note that 
the application does not need to be strong in all categories to be judged 
likely to have a major scientific impact and thus deserve a high priority 
score.  For example, an investigator may propose to carry out important work 
that by its nature is not innovative but is essential to move a field forward.

The review group will examine: the appropriateness of proposed project budget 
and duration; the adequacy of plans to include both genders and minorities and 
their subgroups as appropriate for the scientific goals of the research and 
plans for the recruitment and retention of subjects; the provisions for the 
protection of human and animal subjects; and the safety of the research 
environment.

Specific Review Criteria: PDCR Sites 

The following factors will be considered in evaluating the merit of 
applications for the PDCR sites:

1.  Significance:  Scientific, technical, or medical significance and 
originality of each research project within the application that includes 
specific proposed core research hypotheses relating processes of lung and/or 
colorectal cancer care to health outcomes.

2.   Approach:  Plans and methods for the initial recruitment and retention of 
subjects, and  appropriateness of plans to develop a high-quality data 
collection infrastructure using multiple data sources including pathology 
facilities, medical records, patients, and providers.  Specifically, reviews 
should assess the following: 
A.  Availability of a heterogeneous population and health delivery systems 
for surveillance coverage that complements the proposed research.  Adequacy of 
plans to include minorities and their subgroups, as appropriate for the 
scientific goals of the research.  Plans for enrolling a minimum number of 
cases (1,000 per cancer type) enrolled over a 2-year accrual period.
B.   Proposed rapid case ascertainment system to enroll study subjects 
within the first 6 months following initial diagnosis;  linkages available to 
achieve this through existing cancer registry or other resources.
C.	Proposed methods for conducting mix-mode patient surveys and medical 
record reviews from inpatient and outpatient sources of care;  
D.   Proposed methods for retaining subjects over the course of follow-up, 
and plans for obtaining information about care delivered throughout all phases 
of cancer care.
E.  Plans for obtaining cooperation of patients, next-of-kin, and providers 
such as oncologists, surgeons, radiologists, pathologists, primary care 
physicians, nurses, and tumor registrars, etc., necessary for successful data 
collection efforts.
F.  Plans for development of systems for data collection, formatting and 
transfer of data to the SCC.
G.  Procedures for ensuring confidentiality, and quality assurance and 
control practices to ensure the records and data of all research subjects will 
be protected.
H.  Scientific and technical merit of statistical methods for analyses of 
proposed core research hypotheses.
I.   Scientific and technical merit of proposed special research studies 
(non-core).

3.  Innovation:  Does the project employ novel concepts, approaches or methods 
with regard to collection of data on process and outcomes of community cancer 
care?  Does the project challenge existing paradigms or develop new 
methodologies or technologies?  Are novel or innovative statistical methods 
and approaches proposed for analyzing proposed core research hypotheses and 
data collected within special research projects? 

4.  Investigators:  Qualifications and research experience of the Principal 
Investigator and staff, particularly, but not exclusively, in the area of the 
proposed research should include:
     A.  Demonstration of a track record of interdisciplinary activity.
     B.  Experience in the collection of primary data and management of large 
data sets.
     C. Personnel with credentials and experience in cancer care health 
services research, particularly those related to the clinical study of lung or 
colorectal cancer, epidemiology, biostatistics, data management and computer 
programming.
     D.  Adequacy of time (effort) that the Principal Investigator and staff 
would devote to establishing the core database and conducting the 
proposed studies.

5.   Environment:  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 
support?

The initial review group will also examine:  the appropriateness of proposed 
project budget and duration; the adequacy of plans to include both genders and 
minorities and their subgroups, and children as appropriate for the scientific 
goals of the research;  the provisions for the protection of human and animal 
subjects; and the safety of the research environment. 

Specific Review Criteria: SCC

The following factors will be considered in evaluating the scientific merit of 
applications for the SCC:

1.  Significance:  Scientific and technical merit of plans and procedures 
relating to managing and coordinating collection of core data, support for 
analysis of pooled data by all CanCORS investigators, and providing leadership 
in development of statistical methods.

2.  Approach:  Appropriateness of plans to develop data collection, formatting 
and transfer practices to conform to standards to be determined by CanCORS 
investigators for pooled data analysis, specifically:
A.  Plans for setting up effective data formatting and transfer systems to 
ensure conformation to standards set by the Consortium and to facilitate 
pooled data analysis.  Plans for development and testing of automated 
information systems to ensure and facilitate reporting of standardized core 
data elements by participating research sites to the SCC.
B.  Planned methods for defining and documenting standardized, core data 
elements for processes of care from medical records and self-reported data on 
patient history, quality of life, satisfaction, and other outcomes relevant to 
the primary research questions;  plans for design and development of standard 
data collection forms to collect core elements determined by the CanCORS 
Consortium;   and procedures for implementing centralized training of all 
survey and medical abstract personnel.
C.   Plans and procedures to support the development of uniform quality 
control procedures for data collection within PDCR sites, and procedures for 
ensuring quality control of transmitted core data submitted by PDCR sites to 
the SCC.
D.   Plans to protect data transmitted and stored at the SCC as part of 
protection of research subject confidentiality.
E.   Plans to solicit cooperation and maintain communications among all 
participating PDCR sites, including a description of planned site visits to 
PDCR sites to facilitate the collection of core data and conduct of pooled 
analytic research.
F.   Scientific and technical merit of statistical methods to be developed 
and/or applied to analysis of core data.
G.   Scientific and technical merit of proposed special research studies.

3.  Innovation:   Scientific significance and originality of: 
     A.  Procedures for coordination and quality control of core research data 
reported to the SCC.  
     B.  Statistical methods to measure and analyze the outcomes of cancer 
care in the community setting.

4.  Investigator:  Qualifications and research experience of the Principal 
Investigator and staff, particularly, but not exclusively, in the area of the 
proposed research should include:
    A. Demonstration of a track record of interdisciplinary activity, 
particularly in terms of coordinating large data collection efforts and 
conducting pooled data analysis.
    B. Experience in the management of large primary data sets and 
participation in collaborative studies.
    C. Personnel with credentials and experience in supporting the activities 
of the SCC, including biostatistics, computer systems programmer/analyst, and 
project coordinating and data entry.
    D.  Adequacy of time (effort) that the Principal Investigator and staff 
would devote to establishing the database and conducting the proposed studies. 

5.   Environment:  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 
support?

The initial review group will also examine:  the appropriateness of proposed 
project budget and duration; the adequacy of plans to include both genders and 
minorities and their subgroups, and children as appropriate for the scientific 
goals of the research and plans for the recruitment and retention of subjects;  
the provisions for the protection of human and animal subjects; and the safety 
of the research environment. 

AWARD CRITERIA

The anticipated date of award is September 2001. In the final funding 
selection process of peer-reviewed and scored applications, NCI program staff 
will make funding decisions on the basis of the following criteria:

1.  Scientific and technical merit as determined by peer review.
2.  Appropriateness and duration of the proposed budget in relation to the 
proposed research.
3.  Appropriate mix of minorities and persons of lower socioeconomic status in 
the core study samples overall, and rural/urban and geographic balance among 
the primary data collection research sites.
4.   Diversity of health care delivery systems with respect to organization 
and reimbursement within the Consortium as a whole.
5.  Availability of funds.

Applications recommended by the National Cancer Advisory Board will be 
considered for award based upon the above criteria.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
 
It is the policy of the NIH that women and members of minority groups and 
their sub populations must be included in all NIH supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification is provided that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research.  This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43). 
 
All investigators proposing research involving human subjects should read the 
updated "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:  The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to provide a description of plans 
to conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS.

Because lung and colorectal cancers are diseases of older persons, the 
research issues under study in this RFA are not relevant to children.  
Therefore, applicants may use Justification 1:  the research topic to be 
studied is irrelevant to children; from the policy announcement.  The 
following information is provided to ensure that all NIH applicants are aware 
of the policy.

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by the 
NIH, unless there are clear and compelling scientific and ethical reasons not 
to include them.  This policy applies to all initial (Type 1) applications 
submitted for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
 NIH Policy and Guidelines on the Inclusion of Children as Participants in 
Research Involving Human Subjects  that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators may also obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in an NIH 
solicitation, internet addresses (URLs) should not be used to provide 
information necessary to the review because reviewers are under no obligation 
to view the Internet sites.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health promotion 
and disease prevention objectives of "Healthy People 2010," a PHS-led national 
activity for setting priority areas. This RFA, Cancer Care Outcomes Research 
and Surveillance Consortium, is related to the priority area of cancer 
surveillance and data systems.  Potential applicants may obtain a copy of 
"Healthy People 2010" at http://www.health.gov/healthypeople/.
 
AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.399, Cancer Control Research. Awards are made under authorization of 
Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 
and 284) and administered under NIH grants policies and Federal Regulations 42 
CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and promote the non-use of all tobacco products. In addition, Public 
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain 
facilities (or in some cases, any portion of a facility) in which regular or 
routine education, library, day care, health care, or early childhood 
development services are provided to children. This is consistent with the PHS 
mission to protect and advance the physical and mental health of the American 
people.

REFERENCES

 .  Breslow L, Bailar JCI, Brown BW, Brown HG, Darity WA, Defendi V, et al.   
Measurement of progress against cancer.  JNCI 1990. 82:825-835. 
2. Hewitt M and Simone JV, eds:  Ensuring Quality Cancer Care. National Cancer 
Policy Board, IOM. National Academy Press, Washington, D.C. 1999.   
http://books.nap.edu/catalog/6467.html         

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