Full Text CA-97-018
 
LONG-TERM CANCER SURVIVORS: RESEARCH INITIATIVES
 
NIH GUIDE, Volume 26, Number 30, September 5, 1997
 
RFA:  CA-97-018 (see reissuance RFA-CA-04-003)
 
P.T.


Keywords: 

 
National Cancer Institute
 
Letter of Intent Receipt Date: October 24, 1997
Application Receipt Date: November 25, 1997
 
PURPOSE
 
The National Cancer Institute invites research grant applications to
identify important areas that have an impact on long term survivors
of cancer. The purpose of this RFA is to support research that will
lead to a decrease in the physiologic and psychological morbidity
associated with long term (more than 5 years) survival after cancer
treatment by addressing specific areas that affect cancer survivors
to a greater extent than members of the population at large.
Questions related to the experiences of the cancer survivor
encompassing both physiologic and psychological variables are to be
explored and interventions to promote positive outcomes evaluated
where appropriate. This initiative is expected to provide information
about the incidence and scope of the effects of cancer and its
treatment on survivors, the relationship of treatment to late effects
and to yield new insights about measures that are appropriate to the
potential problems and needs of long term survivors.  This RFA is not
intended to address questions that explore differences between
survivors and non-survivors that may be linked to mechanisms of
disease progression or genetic predisposition.
 
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), Long-Term Cancer Survivors:  Research
Initiatives, is related to the priority areas of long term and late
effects of cancer and its treatment.  Potential applicants may obtain
a copy of "Healthy 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
202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic and foreign, 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.  Teams
of applicants representing a multi-disciplinary approach to the
problem identified are encouraged. Racial/ethnic minority
individuals, women, and persons with disabilities are encouraged to
apply as Principal Investigators. Foreign institutions are not
eligible to apply for First Independent Research Support and
Transition (FIRST) awards.
 
MECHANISM OF SUPPORT
 
This RFA will use the National Institutes of Health (NIH) Research
Project Grant (R01), the Small Grant (R03) and the FIRST (R29) award.
Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant.  The total
project period for an application submitted in response to this RFA
may not exceed 5 years.  The small grant (R03) is limited to 2 years.
The anticipated award date is July, 1998.
 
Because the nature and scope of the research proposed in response to
this RFA may vary, it is anticipated that the size of an award will
vary also. This RFA is a one-time solicitation.  Future unsolicited
competing continuation applications will compete with all
investigator-initiated applications and be reviewed according to the
customary peer review procedures.
 
Except as otherwise stated in this RFA, awards will be administered
under PHS grants policy as stated in the Public Health services Grant
Policy Statement, DHHS Publication No. (OASH) 94-50,000 (REV.) April
1, 1994.
 
FUNDS AVAILABLE
 
The estimated funds (total costs) available for the first year of
support for awards under this RFA will be $3,000,000.  Pending
receipt of a sufficient number of applications of high scientific
merit, the NCI intends to fund a total of approximately 12 to 15
awards in response to this RFA in FY98. Usual PHS policies governing
grants administration and management related to the three mechanisms
(R01, R03 and R29) will apply.  Although this program is provided for
in the financial plans of the NCI, the award of grants pursuant to
this RFA is contingent upon the continuing availability of funds for
this purpose. Funding beyond the first and subsequent years of the
grant will be contingent upon satisfactory progress during the
preceding years and the availability of funds.
 
RESEARCH OBJECTIVES
 
Background
 
There are now approximately 10 million cancer survivors in the United
States, 7 million of whom have survived for at least 5 years. SEER (
Surveillance , Epidemiology and End Results) data demonstrate
improvements in the 5 year relative survival rates for melanoma,
breast, uterine, prostate, testicular and bladder cancer, and for
Hodgkin's Disease and non-Hodgkin's lymphoma, from 1974 - 76 to 1981
- 87 .  There has been a decline in cancer mortality in the US from
1990 to 1995.
 
Problems facing cancer survivors are multifaceted.  They include
physical, emotional and social stresses arising as a result of the
effects of treatment, changes in lifestyle, disruption of home and
family roles, and the fear of recurrence.  Physical morbidity is an
issue for the cancer survivor, as are psychologic and social
morbidity.  Cancer survivors often live with compromise, and face
potential challenges arising as a result of changes in their strength
and endurance, reproductive capacity, sexuality and body image .
Cancer is a disease with both physical and psychosocial sequelae.
Survivors have indicated that their concerns shift over time from
illness related problems and towards societal and interpersonal
issues.
 
There is currently no consensus as to the defined needs of cancer
survivors, or  the long term physiologic and/or psychologic sequelae
of the disease.  Research into these areas is essential to delineate
the long term health outcomes of cancer survivors.  It is anticipated
that new collaborative teams will be formed to address the issues
that range from the biological/physiologic level to the psychosocial
realm.  The nature of the issues suggests a multi- disciplinary
approach that will generate focused methods of assessment, provide
impetus for research on quality of life, explore outcomes of
different approaches to follow-up and surveillance of survivors as
well as inquiries into the impact on family life, insurance and
employment.
 
Many late physiologic effects have been documented for survivors of
childhood cancer.  These include late effects from chemotherapy and
irradiation, and the effects of multi-modal treatment including new
primary cancers, impairment of cognitive, pulmonary, cardiac,
hepatic, and gonadal function , and cosmetic changes.  Reviews of the
existing body of literature point to an increasing number of such
physiologic effects.
 
Areas that continue to be of particular importance to cancer
survivors include: issues of quality of life and psychosocial
adjustment beyond the acute period of treatment; reproduction and
offspring; surveillance for the adverse sequelae of treatment and the
development of new cancers; and the risk of recurrence. Knowledge of
the human toll of having had, and being treated for, cancer measured
in terms of quality of life, social outcomes related to jobs,
insurance, social interactions is needed before interventions to
lessen the negative impact or support the positive adjustment in an
individual are proposed.
 
RESEARCH GOALS
 
The scope of this RFA is limited to long term survivors, defined here
as at least five years from completion of primary cancer therapy and
currently free of disease.  This RFA requests applications that will
provide the information about incidence and scope of effects of
cancer and its treatment on survivors, their relationship to
treatment, and where appropriate, proposals to test interventions,
and the timing of interventions, to reduce the late morbidity of
cancer and cancer therapy and to promote as normal a life as possible
for the survivor.  To achieve these purposes, a descriptive phase may
be included to generate hypotheses about the intervention to be
tested.  It is suggested that the proposals will represent
multi-disciplinary approaches and multiple end points where
appropriate.
 
SCOPE OF RESEARCH
 
This initiative focuses on expanding our understanding of the
physiologic and psychological issues related to cancer survivorship.
Examples of some pertinent areas and research topics are listed
below.  This list is intended to be illustrative, not exhaustive.
Topics are not presented in a priority order:
 
o Prevalence and longitudinal incidence studies of physiologic late
effects, e.g. cardiac toxicities and events, pulmonary compromise,
late effects of limb sparing, minimal breast surgery and
reconstructive surgery, ovarian failure, renal failure, and
neurologic defects.
 
o Prevalence and longitudinal incidence studies of psychosocial late
effects, e.g. job and insurance discrimination, sexuality, quality of
life, depression, cognitive function and mentation.
 
o Prevalence and longitudinal studies of second cancers, including
investigation of risk factors.
 
o Reproductive function, e.g. fertility and health of offspring.
 
o Economic impact, e.g. evaluation of effectiveness and cost of
psychosocial and other interventions that will impact on survivorship
outcomes.
 
o Evaluation of the effectiveness of prevention interventions to
prevent sequelae, e.g. cardioprotective agents, prevention of second
cancers, maintenance of fertility, early interventions during
treatment to lessen negative impact of sequelae.
 
o Exploration of the impact of survivorship related to insurance and
employment discrimination, including that related to the
identification of high risk status, including genetic susceptibility.
 
o Studies in offspring, e.g. birth defects, delayed developmental
milestones and malformation rates.
 
o Development and testing of diverse methodologic approaches specific
to cancer survivors, e.g. instrument development, adaptation and
validation of existing measures for use in special populations
including culturally and ethnically diverse groups and the elderly.
 
o Targeted prevalence studies of specific cancer related effects on
survivors to determine the need for large scale studies.
 
REQUIREMENTS
 
In order for the purposes of the RFA to be accomplished, several
requirements must be addressed:
 
o The focus must be on long term survivors of cancer. This is not
limited to persons who were diagnosed and treated as adults.  Studies
of long term survivors of childhood cancer are encouraged, as are
studies of elderly survivors.
 
o Attention must be paid to the use of appropriately valid and
reliable measures of both physiologic and psychosocial variables.  A
short period of time at the start of the award can be dedicated to
additional validation studies if needed.
 
o The creations of a data base of the cohort that could be used to
facilitate future studies should be considered.
 
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 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 populations) which
have been in effect since 1990.  The new policy contains some
provisions that are substantially different from the 1990 policies..
 
All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH
Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994.
 
Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by October 24, 1997,  a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the Principal
Investigator, the identities of other key personnel and participating
institutions, and the 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 a subsequent application, the information that it contains allows
staff to estimate the potential review workload and avoid conflict of
interest in the review.
 
The letter of intent is to be sent to:
 
Claudette G. Varricchio DSN, RN, FAAN
Division of Cancer Prevention and Control
National Cancer Institute
6130 Executive Boulevard, Room 300
Bethesda, MD  20892- 7340
Telephone:  (301) 496-8541
FAX:  (301) 496-8667
e-mail: [email protected]
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  Application 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, Suite 6095, MSC
7910, Bethesda, MD 20892- 7910, telephone 301/710-0267, E-mail:
[email protected]; and from the program administrator listed
under INQUIRIES.
 
The RFA label available in the PHS 398 (rev. 5/95) application form
must be affixed to the bottom of the face page of the application.
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.
 
Submit a signed, typewritten original of the application, including
the Checklist, and three signed, photocopies, in one package to:
 
Division of Research Grants
National Institutes of Health
6701 Rockledge Drive
Room 1040 - MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD 20817 (for express/courier services)
 
At the time of submission, two additional copies of the application
must be sent to:
 
Mrs. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 636
6130 Executive Boulevard
Bethesda, MD  20892
Rockville, MD 20852 (for express/ courier service)
 
Applications must be received by November 25, 1997.  If an
application is received after that date, it will be returned to the
applicant without review.  The Division of Research Grants (DRG) will
not accept any application in response to this RFA that is
essentially 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 for completeness by DRG
and responsiveness by the National Cancer Institute. Incomplete
applications will be returned to the applicant without further
consideration.  If the application is not responsive to the RFA, DRG
staff may 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
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 National Cancer Institute in accordance with the
review criteria stated below.
 
As part of the initial merit review, a process (triage) may be used
by the initial review group in which applications will be determined
to be competitive or non-competitive based on their scientific merit
relative to other applications received in response to the RFA.
Applications judged to be competitive will be discussed and be
assigned a priority score.  Applications determined to be
non-competitive will be withdrawn from further consideration and the
Principal Investigator and the official signing for the applicant
organization will be notified.
 
REVIEW CRITERIA
 
The five criteria to be used in the evaluation of grant applications
are listed below.
 
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.
 
1.  Significance.  Does this study address an important problem? If
the aims of the application are achieved, how will scientific
knowledge be advanced?  What will be the effect of these studies on
the concepts or methods that drive this field?
 
2.  Approach.  Are the conceptual framework, design, methods, and
analyses adequately developed, well-integrated, and appropriate to
the aims of the project?  Does the applicant acknowledge potential
problem areas and consider alternative tactics?
 
3.  Innovation.  Does the project employ novel concepts, approaches
or method?  Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
 
4.  Investigator.  Is the investigator appropriately trained and well
suited to carry out this work?  Is the work proposed appropriate to
the experience level of the principal investigator and other
researchers (if any)?
 
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 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
 
Applications found to have significant and substantial merit will be
considered for funding by the following:
 
o  priority score
o  availability of funds
o  programmatic priorities
 
SCHEDULE
 
Letter of Intent Receipt Date:             October 24, 1997
Application Receipt Date:                  November 25, 1997
Review by National Cancer Advisory Board:  May 1998
Anticipated Date of Award:                 July  1998
 
INQUIRIES
 
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:
 
Claudette G. Varricchio DSN, RN, FAAN
Division of Cancer Prevention and Control
National Cancer Institute
Executive Plaza North, Room 300
Bethesda, MD  20892- 7340
Telephone:  (301) 496-8541
FAX: (301)  496 8667
E-mail: [email protected]
 
Direct inquiries regarding fiscal matters to:
 
Joy L. McCauley
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
6120 Executive Boulevard
Bethesda, MD  20892
Telephone: (301) 496-7800, ext. 253
FAX: (301) 496-8601
E-mail: [email protected]
 
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 PHS 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 Public Health Service (PHS) 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.  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.
 
.

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