Full Text CA-94-019

CANCER PREVENTION AND RURAL HEALTH

NIH GUIDE, Volume 23, Number 19, May 20, 1994

RFA:  CA-94-019

P.T. 34

Keywords: 
  Cancer/Carcinogenesis 
  0730075 
  Disease Prevention+ 
  Diagnosis, Medical 


National Cancer Institute

Letter of Intent Receipt Date:  June 20, 1994
Application Receipt Date:  August 19, 1994

PURPOSE

The Public Health Applications Research Branch, Division of Cancer
Prevention and Control (DCPC), National Cancer Institute (NCI),
invites research grant applications for research projects to develop,
implement, and evaluate cancer prevention and early detection
intervention strategies for rural populations.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This Request
for Applications (RFA), Cancer Prevention and Rural Health, is
related to the priority area of cancer.  Potential applicants may
obtain a copy of "Health People 2000" (Full Report:  Stock No.
017-001-00474-0) or "Healthy People 2000" (Summary Report:  Stock No.
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic, public and private,
for-profit and non-profit, organizations such as universities, public
health departments, voluntary organizations, research centers,
hospitals, consortia of health providers, and units of state and
local governments serving a substantial rural population.
Collaborating applicant organizations and/or institutions with
multidisciplinary expertise and access to rural populations are
encouraged.  Awards will not be made to foreign institutions and
applicants from domestic organizations may not include international
components.  Applications from minority and women investigators are
encouraged.

MECHANISM OF SUPPORT

Support of this program will be through the NIH individual research
grant (R01).  Applicants will be responsible for the planning,
direction, and execution of the proposed project.  However, it is
anticipated that grantees funded under this RFA will meet regularly
for purposes of sharing design and evaluation strategies, comparing
results where possible, and distilling lessons learned from all grant
projects.  (See Special Requirements section.)  The total project
period for an application submitted in response to this RFA may not
exceed four years.  The anticipated award date is March 1995.

This RFA is a one-time solicitation.  Generally, future unsolicited
competitive continuation applications will compete with all
investigator-initiated applications and be reviewed by the Division
of Research Grants (DRG).  However, if the NCI determines that there
is a sufficient continuing program need, a request for competitive
continuation applications will be announced.  Only recipients of
awards under this RFA will be eligible to apply.

FUNDS AVAILABLE

Approximately $1,000,000 in total costs per year for up to four years
will be committed to specifically fund applications that are
submitted in response to this RFA.  It is anticipated that three to
five awards will be made and that the average annual direct costs
will be $175,000 per award.  This funding level is dependent on the
receipt of a sufficient number of applications of high scientific
merit.  The total project period for an application submitted in
response to the present RFA may not exceed four years.   The earliest
feasible start-date for the initial awards will be March 1, 1995.
Although this program is provided for in the financial plans of the
NCI, the award of grants pursuant to this RFA is also contingent upon
the availability of funds for this purpose.

RESEARCH OBJECTIVES

Background

The NCI is interested in stimulating research to develop effective
methods for increasing cancer prevention and early detection services
in rural populations and settings.  Although rural residents are
characterized by relatively low mortality rates, they experience
higher rates of chronic disease, including cancer.  The majority of
elevated cancer mortality rates among rural versus urban residents
are reversed with age, sex, and race adjustments for most cancers;
however, some notable exceptions exist, such as lip and some skin
cancers.  In addition, there is evidence that cancer mortality among
rural populations may be increasing more rapidly than increases among
urban populations.  Rural cancer patients are reportedly diagnosed at
later stages of disease, have higher proportions of unstaged cancers
at diagnosis, and are at more advanced stages of illness when
referred to home health care agencies.

Cancer prevention and early detection practices in rural settings
appear to lag behind urban settings.  Smoking rates appear to be
dropping more slowly in predominately rural states and use of breast
and cervical cancer screening is reported to be lower in rural
compared to urban settings.  A number of studies indicate that rural
residents receive fewer cancer services than their urban
counterparts, that rural residents utilize telephone cancer
information services less frequently than urban residents, and that
rural communities have fewer cancer prevention activities than urban
communities.

Rural communities differ from urban communities in other important
ways.  Rural residents tend to have lower income, higher poverty,
less education, greater adherence to traditional gender roles and
longer periods of public assistance than urban residents.  Rural
residents have fewer choices about where and from whom they will
receive health care: almost one-half of the resources for rural
health comes from Federal sources, fewer specialized services are
available in rural settings and rural hospitals are closing at an
alarming rate.  In addition, rural residents are limited by lack of
public transportation and poorer roads, they are more physically
isolated than urban counterparts and they have been characterized by
a tradition of individualism, self-sufficiency and community and
family orientations.

Major reductions in U.S. cancer mortality and morbidity are believed
to be dependent on the widespread adoption of cancer prevention
behaviors and use of early detection services; this includes rural
populations.  Unfortunately, relatively little research has been
published on effective intervention strategies for meeting the unique
needs of rural populations.  This RFA is intended to address this
problem.

Research Goals and Scope

The primary goal of this project is to develop, implement, and
evaluate cancer prevention and early detection intervention
strategies for rural populations and settings.

Definition of Rural - For purposes of this procurement, rural refers
to areas of low population size and density that are categorized as
(1) nonmetropolitan, using the designation of Metropolitan
Statistical Areas by the U.S. Office of Management and Budget (OMB)
or (2) rural, using the definition formulated by the U.S. Bureau of
the Census (RHRP 1991).

Intervention Approaches - Investigators are encouraged to submit
applications that focus on the prevention and/or screening and early
detection of cancer.  Research projects should address the cancer
concerns of special relevance to rural populations.  For example,
cancer prevention research projects might address protection from lip
and skin cancer, tobacco use reduction, diet and nutrition
modification, or control of pesticides and other
occupational/environmental carcinogens.  Cancer screening and early
detection research projects might address the frequency and/or
quality of clinical breast exams and mammography screening for the
early detection of breast cancer, pap smears for the early detection
of cervical cancer and/or rectal exams and proctosigmoidoscopy for
the early detection of colon cancer.

Appropriate behavioral, educational and/or organizational scientific
theories should provide the foundation for identification of barriers
to cancer prevention and control in rural populations and settings,
design of appropriate intervention approaches and evaluation of
intervention outcomes.  Interventions may be targeted to individuals
within rural communities, health care providers serving rural
communities, public health structures, community organizations, or
other appropriate individuals and/or groups.  Interventions may
address individual, community and/or organizational level barriers to
effective cancer prevention and control.  Consideration must be given
to the specific demographic, socioeconomic, cultural, and geographic
factors that affect rural health-related behaviors and health
provider practices.

Examples of interventions focusing on health-related prevention and
early detection behaviors in rural populations might include
increasing social support for early detection practices, providing
transportation and/or enhancing availability and value judgements of
services, conducting education campaigns that build upon rural values
and consider sociodemographic characteristics, providing incentives
for maintenance of screening behaviors, and/or stimulating policies
that reduce cost barriers.  These interventions might involve women's
groups, fraternal organizations, youth clubs, churches, unions,
worksites, and local business such as grocery stores or beauty
parlors, and other community-based organizations.

Examples of interventions seeking to increase cancer prevention and
early detection behaviors by targeting health care providers and
systems of health services delivery in rural settings might include
developing training modules in conjunction with rural health training
centers such as rural Area Health Education Centers (AHECs),
providing training to health care providers and allied health
professionals in delivering cancer risk information to minimize
anxiety and motivate adherence to cancer prevention and early
detection guidelines, developing office systems to enhance delivery
of services, developing approaches to modify referral patterns and
followup procedures especially for specialized services, assisting
patients navigate the health system including for example completion
of billing and insurance forms, and developing communications
strategies and materials tailored to patient characteristics and
beliefs, such a limited literacy skills and misconceptions about
cancer cure and treatment.

Evaluation - Evaluation of the effectiveness of interventions to
improve the health status of rural residents is a critical component
of this RFA.  An adequate design must be employed to reliably
demonstrate the effectiveness of interventions in reaching the target
population and affecting cancer prevention and control practices.
Baseline information must be obtained, including assessment of
population demographics, health status, current knowledge, attitudes,
beliefs and practices, health service utilization patterns, etc. as
appropriate to the study questions.

Randomization of the target population to intervention and
nonintervention groups is the preferred study design, although other
well justified study designs with appropriate comparisons, such as
multiple time series designs, will be considered.  Stratification
into specific groups (e.g., occupation, income, education, marital
status, geographic setting, etc.) also may be appropriate to address
special research questions of particular importance in rural
populations and settings.  However, comparison groups must be of
sufficient size to provide the statistical power needed to detect
significant differences and appropriate power calculations should be
provided.  Plans for statistical analyses should be described in
detail adequate to evaluate the potential for success of the
application research plan.

Final outcome measures should reflect improvements in health status
and/or health-related behaviors, and may include for example, changes
in stage at diagnosis, proportion of unstaged cases at diagnosis,
number of preventive care visits, number and frequency of screening
tests performed, compliance with screening guidelines, case fatality,
time from diagnosis to treatment.  Interim measures such as
improvements in knowledge, attitudes, beliefs and/or intentions may
be included if relevant to the intervention being tested.

Applications must include a clear plan for process evaluation.
Process evaluation should provide information about implementation of
the intervention and factors that both positively and negatively
influenced implementation and any changes to the intervention as it
was being implemented.  Process information should be used to
facilitate intervention design and implementation as well as
interpretation of outcome results.

High priority will be given to research projects that are applicable
to rural communities nationwide and that can be easily replicated and
disseminated.  Successful interventions developed through this
research will be used to assist health professionals working in rural
areas around the country to address cancer prevention and early
detection needs.  Research results will be disseminated through
appropriate NCI programs such as the Appalachia Leadership Initiative
on Cancer (ALIC), the Cancer Information Service (CIS), the Cancer
Centers, and the Community Clinical Oncology Programs (CCOPs).

SPECIAL REQUIREMENTS

As stated under MECHANISM OF SUPPORT, grantees may be expected to
collaborate on research and project reporting strategies and to share
project progress and experiences.  Thus, each grantee may include in
her/his budget funds for at least two investigators to attend two
meetings per year in Rockville, MD with fellow grantees.

Investigators will be expected to supply a final report in a specific
format, which summarizes both successes and failures in order to
contribute to the dissemination of community intervention research.
In addition, grantees may be expected to participate in a joint
summary of results of all grants.

STUDY POPULATIONS

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 subpopulations 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 new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Population) which
have been in effect since 1990.  The new policy contains some new
provisions that are substantially different from the 1990 policies.

All investigators proposing research involving human subjects should
read the "NIH Guidelines on the Inclusion of Women and Minorities as
Subjects in Clinical Research," which was reprinted in the Federal
Register of March 28, 1994 (59 FR 14508-14513) to correct typesetting
errors in the earlier publication, and reprinted in the NIH GUIDE FOR
GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11.

Investigators may obtain copies from these sources or from the
program staff or contact person listed below.  Program staff may also
provide additional relevant information concerning the policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by June 20, 1994, a
letter of intent that includes a descriptive title of the proposed
research, the name and address of the Principal Investigator, the
names of other key personnel, the participating institutions, and the
number and title of the RFA in response to which an application may
be submitted.

Although a letter of intent is not required, is not binding, and does
not enter into the final review of subsequent applications, the
information it contains is helpful in planning for the review of
applications.  It allows NCI staff to estimate the potential review
workload and to avoid possible conflict of interest in review.  The
letter of intent is to be sent to Dr. Marianne Haenlein Alciati at
the address listed under INQUIRIES.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research; from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone
(301-435-0714).

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

Submit a signed, typewritten original of the application, including
the Checklist and three signed, exact, clear and single-sided
photocopies, in one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, two additional copies of the application
must also be sent to:

Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 636A
6130 Executive Boulevard
Rockville, MD  20852 (If hand-delivered or delivery service)
Bethesda, MD  20892 (If using US Postal Service)

It is important to send these copies at the same time that the
original and three copies are sent to DRG, otherwise, the NCI cannot
guarantee that the applications will be reviewed in competition with
other applications received by the designated receipt date.

Applications must be received by August 19, 1994.  If an application
is received after that date, it will be returned.  The DRG will not
accept any application in response to this RFA that is the same as
one currently pending initial review, unless the applicant withdraws
the pending application.  The DRG will not accept any application
that is essentially the same as one already reviewed.  This does not
preclude the submission of substantial revisions of applications
already reviewed, but such applications must include an introduction
addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed by DRG for completeness
and for responsiveness by NCI.  Incomplete applications will be
returned to the application without further consideration.  If the
applicant is not responsive to the RFA, NCI program staff will
contact the applicant to determine whether to return the application
to the applicant or submit it for review in competition with
unsolicited applications at the next review cycle.

Applications may receive a preliminary scientific peer review
(triage) by an NCI peer review group on the basis of relative
competitiveness.  The NCI will remove from further competition those
applications judged to be non-competitive for award and notify the
applicant principal investigator and institutional official.  Those
applications that are competitive will be evaluated in accordance
with criteria stated below for scientific/technical merit by an
appropriate peer review group convened by the Division of Extramural
Activities, NCI.  The second level of review will be provided by the
National Cancer Advisory Board.

The review group will assess the scientific merit of the studies
according to the following criteria:

o  The extent to which the application demonstrates an understanding
of the barriers to cancer control in rural populations and settings;

o  Rationale for and appropriateness of the selected intervention
approach; consideration of appropriate behavioral, educational and/or
organizational scientific theories in intervention selection and
development; consideration of sociodemographic, cultural, economic
factors and cancer control needs in intervention selections and
development;

o  Scientific/technical merit, adequacy, appropriateness, and
feasibility of the evaluation plan including consideration of
methodologic, measurement/instrumentation, sample size and power
considerations; sufficient detail in description of methods or
procedures; and sufficient allocation of resources;

o  Understanding of the selected rural population, particularly in
terms of health factors such as the current status of access to and
utilization of health care services, knowledge, attitudes, beliefs
and behavior relevant to cancer prevention and control and cancer
control needs as well as other economic, cultural and
sociodemographic factors that might influence cancer prevention and
control initiatives;

o  Adequacy and soundness of the staffing and project management
plans, including the overall balance of necessary disciplines and
expertise in relation to the objectives of the research project;
evidence of the capability, experience and qualifications of the
principal investigator and other investigators as well as cooperating
institution's technical staffs to implement the project successfully;
and adequacy of time (effort) which the principal investigator and
other investigators, if any, would devote to the proposed studies;

o  Feasibility of the project within the resources and timeframes
proposed; appropriateness of the proposed budget and duration in
relation to the proposed initiative; and inclusion of specific
written agreements with cooperating institutions, including those
agencies that may be providing services and/or the settings for these
services.

The review group will critically examine the submitted budget and
will recommend an appropriate budget and period of support for each
approved application.

AWARD CRITERIA

NCI staff will take into account demographic and geographic
distribution of peer-reviewed and approved applications, the
availability of funds, and priority scores in the final selection
process.  Several applications approved for funding and studying the
same rural population will be considered, but may not be awarded.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.

Direct inquiries regarding programmatic issues to:

Marianne Haenlein Alciati, Ph.D.
Public Health Agency Section
National Cancer Institute
Executive Plaza North, Room 233
Bethesda, MD  20892
Telephone:  (301) 496-8584

Direct inquiries regarding fiscal matters to:

Robert E. Hawkins
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 242
Bethesda, MD  20892-4200
Telephone:  (301) 496-7800, ext. 213

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.399, Cancer Control.  Awards are made under
authorization of the Public Health Service Act, Title IV, Part A
(Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and
285) and administered under HHS policies and grant regulations.  This
program is not subject to the intergovernmental review requirements
of Executive Order 12372 or Health Systems Agency review.

The Public Health Service strongly encourages all grant recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.

.

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