Full Text CA-93-14

ADULT SURVIVORS OF CANCER

NIH GUIDE, Volume 22, Number 6, February 12, 1993

RFA:  CA-93-14

P.T. 34

Keywords: 
  Cancer/Carcinogenesis 
  Social Psychology 
  Rehabilitation/Therapy, Occupation 


National Cancer Institute

Letter of Intent Receipt Date:  March 16, 1993
Application Receipt Date:  May 21, 1993

PURPOSE

The Division of Cancer Prevention and Control (DCPC) of the National
Cancer Institute (NCI)  invites investigator-initiated grant
applications for research directed at decreasing the functional and
psychosocial morbidity associated with cancer survivorship, i.e., in
persons who have completed therapy and have a good prognosis for cure
or long-term survival.

Applicants are requested to develop, implement, and evaluate
interventions aimed at improving the rehabilitation and quality of
life of cancer survivors related to psychosocial sequelae, vocational
rehabilitation, or adaptation to long-term functional impairment.

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), Adult Survivors of Cancer, is related to the
priority area of cancer. 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 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and
non-profit, public and private organizations, such as universities,
colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal government.
Applications from minority individuals and women are encouraged.

MECHANISM OF SUPPORT

Support of this program will be through the National Institutes of
Health (NIH) research project grant (R01).  Applicants will be
responsible for the planning, direction, and execution of the
proposed project.  The total project period for applications
submitted in response to this RFA should not exceed four years.
Awards will be administered under PHS grants policy as stated in the
Public Health Service Grants Policy Statement, DHHS Publication No.
(OASH) 90-50,000, revised October 1, 1990.

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.  The anticipated amount of the direct costs per award will
vary from $100,000 to $300,000.  Allowable direct costs for the
intervention will NOT include payment for cancer screening tests or
services and procedures which are a routine part of cancer treatment
and patient care.  Expenses incurred in development and
implementation of the proposed research, including baseline and
follow-up surveys, design of materials, and professional education
are allowable costs.

Budgets should include travel funds for the Principal Investigator
and co-investigators to one two-day meeting in Bethesda, MD, to
facilitate discussions with program staff and to foster sharing of
work in progress with other researchers.

This RFA is a one-time solicitation.  Future unsolicited competitive
continuation applications will compete with all other
investigator-initiated research grant applications and be peer
reviewed by a chartered study section in the Division of Research
Grants (DRG), NIH.  However, if it is  determined 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

Total costs of $2,500,000 per year for four years will be committed
to specifically fund applications which are submitted in response to
this RFA.  It is anticipated that four or five awards will be made.
This funding level is dependent upon the receipt of a sufficient
number of applications of high scientific merit.  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

About 440,000 Americans or four out of 10 patients who were diagnosed
with cancer in 1991 will be alive five years after diagnosis (1).
The trends in overall cancer survival rates show a greater increase
when they are adjusted for the primary cancer site distribution.  For
example, SEER data demonstrate significant improvements in the five
year relative survival rates in melanoma, breast, uterus, prostate,
testis, bladder, Hodgkin's disease and non-Hodgkin's lymphoma, from
1974-76 to 1981-87, (2).  However, even with this improvement, the
literature offers few reports of research documenting effective
interventions  to alleviate problems in this group of people.

Problems facing long-term survivors are being recognized and reported
in the descriptive literature.  The survivors face a multitude of
physical, emotional, and social stresses from the effects of
treatment, changes in lifestyle, disruption of home and family roles
and the fear of recurrence.  The cancer survivor deals not only with
physical morbidity, but faces the risk of psychological and social
morbidity as well (3, 4).  Cancer survivors often live with
compromise.  They are challenged by changes in their endurance and
strength, reproductive capacity, sexuality, and body image (3, 5).
Cancer can be understood as a disease with both physical and
psychosocial sequelae.  Much is known about the physical late effects
of cancer and its treatment; less is known about the psychosocial
morbidity of these physical sequelae.  Though cancer survivors appear
to function quite adequately in their daily lives, they may
experience periods of distress that can be relieved (4).  The
problems of the cancer survivor are not extensions of the problems of
the cancer patient in treatment.  They are qualitatively different:
more diverse, less "medical," difficult to anticipate, and less
extreme.  There is a trend in these problems away from
illness-related ones and toward societal, interpersonal ones
(4,6,7,8,9,10).

A summary of the literature on physiologic sequela (11) recognizes
the need for research to minimize potential unwanted effects of
therapy , both immediate and long term.  The present concept
addresses the late effects and sequela of treatment which affect the
functional ability and quality of life of cancer survivors.

An overview of the psychosocial implications of long-term survival of
adults who have had cancer gives direction for important
interventions that require attention (12).  Although most patients
improve from baseline measures of psychological distress, there is
evidence that 20 percent to 30 percent of patients continue to
experience clinically significant distress and poorer well-being long
after diagnosis (4, 13).  The long-term cancer survivor may face
physical and/or psychosocial complications that can be delayed as
much as 20 years or more.

Cancer survivors are now speaking up on their own behalf about the
need for a continuing support network and the need for research to
address ongoing informational, educational, psychological, and social
concerns following cancer diagnosis and treatment (14).

Research Goals and Scope

The goals of this research initiative are to improve quality of life
by decreasing the functional and psychosocial morbidity associated
with cancer survivorship through the development and testing of
interventions which facilitate rehabilitation of adult cancer
survivors and enhance their re-entry into society.

The specific objectives of the research are:

o  To define and explore the functional and psychosocial issues
facing adult cancer survivors and the barriers to reintegration into
society.

o  To develop and evaluate specific interventions to enhance
adaptation to long term physical impairment, vocational
rehabilitation, psychosocial adjustment and/or return to
pre-diagnosis life style.

This concept invites R01 applications to test interventions in a two
phase approach:

o  Descriptive phase to gather detailed baseline information and
refine the proposed interventions as indicated by findings;

o  Evaluative phase in which the intervention is implemented and its
impact is assessed.

The application should define the population, identify the problem,
describe the intervention and outline the evaluation plan.
Applications should reflect a strong research orientation with
attention to quality of life and its dimensions reflected by
psychosocial variables, vocational rehabilitation, and adaptation to
long term physical impairment or functional rehabilitation.

Study Design

For the purposes of this RFA, adult survivors are defined as persons
diagnosed and treated for cancer after age 21, who have completed
therapy and have a good prognosis for cure or long-term survival.
The study sample can be homogeneous on specific characteristics
related to disease, treatment, age or culture.  Groups can be defined
by (1) primary cancer site with similar treatment approaches facing
common issues (e.g., gynecological malignancies, malignancies treated
with bone marrow transplantation); (2) age cohort facing similar life
events (e.g., return to work or retirement, family responsibilities);
(3) cultural and ethnic influences.

The research hypotheses should be based on relevant conceptual models
or theories and should address issues in at least one of the
following areas:

o  Long term physical impairment.

o  Self-image, sexuality, reproductive potential.

o  Interpersonal relationships and social functioning (family, close
friends, broader social groups).

o  Vocational rehabilitation, employment or insurability.

o  Medical uncertainties (relapse, late complications, second
malignancies).

o  Cultural and ethnic background and values as influences on
adaptation to cancer.

The proposed interventions may be (1) newly developed, (2) adapted
from experience with other groups of cancer patients, or (3) drawn
from those which have been shown to have been of benefit in the
long-term rehabilitation of patients in other disease categories.
Interventions may be drawn from other disciplines in the social
sciences.  Short, time limited interventions with clear end-points or
long term, continuous interventions where the effect can be measured
within the study time frame are equally acceptable.  The proposed
intervention must be described in detail in the proposal.

This intervention research may incorporate a descriptive phase for
collection of baseline data, or a short pilot phase for refining the
proposed intervention.  In the descriptive phase, interviews,
surveys, focus groups or other sociologic approaches may be suitable.

Applicants are expected to have a foundation of previous work which
will require a minimal descriptive, exploratory phase before moving
to the intervention and evaluation phases.  However, the principal
focus of the research should be to predict problems and evaluate
interventions to accomplish the rehabilitation and reintegration of
the adult survivor of cancer.

Study Evaluation

Existing measures of the outcome variables of interest, (i.e., direct
or indirect measures of quality of life and its domains) with
established validity and reliability must be used (15, 16, 17).
These may be drawn from other disciplines in the social sciences.
Investigators are expected to select endpoints that reflect the
quality of long-term survival, for example: functional status,
changes in use of services, or degree of return to pre-morbid
lifestyle, work and activities.

The design may include qualitative or quantitative methodologies and
must include a systematic documentation of the problem.  An
experimental design is the preferred approach; however,
quasi-experimental designs may be appropriate in some circumstances.
Outcome variables must be clearly defined and assessed by valid and
reliable techniques.  Analysis will include descriptions of the
population of adult survivors and the needs identified by this group.
Usual evaluative methods can be used to determine the effectiveness
of interventions.  Some of these evaluative methods may be drawn from
education, social sciences or health services research.
Investigators are expected to select endpoints that reflect the
quality of long-term survival, i.e., quality of life and/or its
specific domains related to the intervention (16, 17, 18, 19).
Additional end points could include functional status, changes in use
of services, or degree of return to pre-morbid lifestyle, work and
activities.  Confounding variables such as programs available within
the community should be considered when assessing the outcomes.
Quantitative methods should be used to determine efficacy.
Qualitative methods may be included to enhance the understanding and
interpretation of the quantitative findings and enrich the
interpretation of the data.

The approach should be interdisciplinary in nature and have the
potential to be transferred effectively to diverse practice settings.
Collaboration with oncology subspecialists, social workers,
vocational counselors, health services researchers, health
economists, physical and occupational therapists, psychologists,
health educators and other interested disciplines should be sought as
appropriate to address the complexity of the issues identified in the
hypotheses.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

NIH policy is that applicants for NIH clinical research grants and
cooperative agreements are required to include minorities and women
in study populations so that research findings can be of benefit to
all persons at risk of the disease, disorder or condition under
study; special emphasis must placed on the need for inclusion of
minorities and women in studies of diseases, disorders and conditions
which disproportionately affect them.  This policy is intended to
apply to males and females of all ages.  If women or minorities are
excluded or inadequately represented in clinical research,
particularly in proposed population-based studies, a clear and
compelling rationale must be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues must be addressed in developing a research
design and sample size appropriate for the scientific objectives of
the study.  This information must be included in the form PHS 398
(rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in
Section 5, Human Subjects.  Applicants are urged to assess carefully
the feasibility of including the broadest possible representation of
minority groups.  However, the NIH recognizes that it may not be
feasible or appropriate in all research projects to include
representation of the full array of United States racial/ethnic
minority populations [i.e., Native Americans (including American
Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks,
Hispanics].

The rationale for studies on single minority population groups should
be provided.

For the purpose of this policy, clinical research is defined as human
biomedical and behavioral studies of etiology, epidemiology,
prevention (and preventive strategies), diagnosis, or treatment of
diseases, disorders or conditions, including but not limited to
clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.  However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.

For foreign awards, the policy on inclusion of women applies fully;
since the definition of minority differs in other countries, the
applicant must discuss the relevance of research involving foreign
population groups to the United States' populations, including
minorities.

If the required information is not contained within the application,
the application will be returned.

Peer reviewers will address specifically whether the Research Plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the
selected study population is inadequate, it will be considered a
scientific weakness or deficiency in the study design and will be
reflected in assigning the priority score to the application.

All applications for clinical research submitted to the NIH are
required to address these policies.  NIH funding components will not
award grants or cooperative agreements that do not comply with these
policies.

LETTER OF INTENT

Prospective applicants are asked to submit, by March 16, 1993 a
letter of intent that includes a descriptive title of the proposed
research; the name, address, telephone ,and FAX numbers of the
Principal Investigator; the names of other key personnel; the
participating institution(s); 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, it contains
information that is helpful in planning for the review.  The letter
of intent allows NCI staff to estimate the potential review workload
and helps to avoid conflict of interest in the review.

The letter of intent is to be sent to:

Claudette Varricchio, D.S.N, R.N., O.C.N., F.A.A.N.
Division of Cancer Prevention and Control
National Cancer Institute
6130 Executive Boulevard
Executive Plaza North, Suite 300
Bethesda, MD  20892
Telephone:  (301) 496-8541
FAX:  (301) 496-8667

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  The application package is available
at most institutional offices of sponsored research; from the Office
of Grants Inquiries, Division of Research Grants, National Institutes
of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone
301-496-7441; and from the NCI Program Director named below.

The RFA label available in the application form PHS 398 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 number and title must 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 photocopies, in one package to
the DRG at the address below.  The photocopies must be clear and
single-sided.

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 be sent to:

Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 650
Bethesda, MD  20892

Applications must be received by close of business, May 21, 1993.  If
an application is received after that date, it will be returned to
the applicant.  The DRG 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 DRG will not accept any application that is
essentially the same as one already reviewed.  This does not preclude
the submission of a substantial revision to an already reviewed
application, but such an application must include an introduction
addressing the previous critique.

REVIEW CONSIDERATIONS

Review Procedure

Upon receipt, applications will be reviewed initially by the DRG for
completeness.  An incomplete application will be returned to the
applicant without further consideration.  Evaluation for
responsiveness to the RFA is an NCI program staff function.
Applications will be judged to determine how well they meet the goals
and objectives of the program as described in the RFA.  Applications
judged non-responsive will be returned, but may be submitted as
investigator-initiated research grant applications at the next
regular receipt date.  Questions concerning the relevance of proposed
research to the RFA may be directed to the Program Directors listed
under INQUIRIES.

If the number of applications is large compared to the number of
awards to be made, the NCI may conduct a preliminary scientific peer
review to triage applications on the basis of relative
competitiveness and to eliminate those applications which are clearly
not competitive.  The NCI will withdraw from further competition
those applications judged to be noncompetitive and notify the
applicant and institutional business official.

Those applications judged to be both competitive and responsive will
be further evaluated according to the review criteria stated below
for scientific and technical merit by an appropriate peer review
group convened by the Division of Extramural Activities, NCI.  The
second level of review by the National Cancer Advisory Board will
consider the special needs and the research priorities of the
Institute.

Review Criteria

Applications responsive to this competitive solicitation will be
reviewed in accordance with the criteria stated below:

o  Scientific merit of the research design, clinical significance and
originality of the proposed intervention, including outcome measures
and the feasibility of the procedures to be used.

o  Appropriateness and adequacy of the experimental approach and
methodology proposed to the goals and objectives of the RFA.

o  Qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research.  Inclusion of professionals
representing diverse disciplines, as appropriate, on the leadership
level.

o  Availability and proposed use of multidisciplinary expertise from
related fields of behavioral and social sciences, health services
evaluation, and specialized health care professionals as appropriate
for the focus of the proposed research.

o  Availability of resources necessary to perform the research.

o  Feasibility of applying successful interventions in community
practice settings.

o  Adequacy of the proposed means for protecting against hazardous or
unethical research procedures.

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

AWARD CRITERIA

The anticipated date of award is April 1, 1994.

The following factors will be considered in making funding decisions:
(1) the scientific merit of the proposed project as determined by
peer review; (2) availability of funds; and (3) program balance among
research areas as described in the RFA.

INQUIRIES

Written and telephone inquiries concerning the objectives and scope
of this RFA, and inquiries about whether or not specific proposed
research would be responsive, are encouraged and may be directed to
the Program Directors at the addresses provided below.  Program
Directors welcome the opportunity to clarify any scientific or
programmatic issues or questions from potential applicants.

Claudette Varricchio, D.S.N, R.N., O.C.N., F.A.A.N.
Division of Cancer Prevention and Control
National Cancer Institute
Executive Plaza North, Suite 300
Bethesda, MD  20892
Telephone:  (301) 496-8541
FAX:  (301) 496-8667

Written and telephone inquiries of a budgetary, administrative,
and/or policy nature may be directed to:

Mrs. Eileen M. Natoli
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Suite 242
Bethesda, MD  20892
Telephone:  (301) 496-7800
FAX:  (301) 496-8601

The National Center for Nursing Research is also interested in
research focused on adult survivors of cancer.  Inquiries may be made
to:

June R. Lunney, Ph.D., R.N.
Acute and Chronic Disease Branch
National Center for Nursing Research
Building 31, Room 5B09
Bethesda, MD  20892
Telephone:  (301) 496-0523

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.399, Cancer Control Research, and 93.361, Nursing
Research.  Awards are made under the 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 Part 74.
This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency
review.

References

1.  American Cancer Society. 1991, Cancer Facts and Figures. American
Cancer Society, New York, NY., p. 3.

2.  National Cancer Institute, Division of Cancer Prevention and
Control, Surveillance Program.  1991, Cancer Statistics Review,
1973-1988. US Dept. of Health and Human Services, NIH Pub. No
91-2789.

3.  Rose, MA. 1989, Health Promotion and Risk Prevention:
Applications for Cancer Survivors, Oncology Nursing Forum, 16:3,
335-340.

4.  Smith, K, Lesko, LM. 1988, Psychosocial Problems in Cancer
Survivors. Oncology, 2:1, 33-40.

5.  Broder S. 1991, The Human Costs of Cancer and the Response of the
National Cancer Program.  Cancer. 67: 1716-1717.

6.  Cella, DF. 1987, Cancer Survival: Psychosocial and Public Issues.
Cancer Investigation, 5:1, 59-67.

7.  Berry, DL, Catanzaro, M. 1992, Persons With Cancer and Their
Return to the Workplace. Cancer Nursing.  15:1, 40-46.

8.  Johansson, S, Steineck, G, Hursti, T, Fredrikson, M, Furst, CJ,
Peterson, C.  1992, Aspects of Patient Care.  Cancer Nursing.  15:1,
54-60.

9.  Hoffman, B. 1991, Employment Discrimination: Another Hurdle for
Cancer Survivors.  Cancer Investigation.  9:5, 598-595.

10.  Schmale, AH, Morrow, GR, Schmitt, MH, Adler, LM, Enelow, A,
Murawske, BJ, Gates, C.  1983, Well-Being of Cancer Survivors.
Psychosomatic Medicine.  45:2, 163-169.

11.  Loescher, LJ, Welch-McCaffrey, D, Leigh, SA, Hoffman, B,
Meyskens, FL. 1989, Surviving Adult Cancers. Part 1: Physiologic
Effects. Annals of Internal Medicine, 111:5, 411-432.

12.  Welch-McCaffrey, D, Hoffman, B, Leigh SA, Loescher, LJ, Meyskens
FL. 1989, Surviving Adult Cancer. Part 2: Psychosocial Implications.
Annals of Internal Medicine 111:6, 517-524.

13.  Ell, K, Nishimoto, R, Morvay, T, Mantell, J, Hamovitch, M. 1989,
A Longitudinal Analysis of Psychological Adaptation Among Survivors
of Cancer.  Cancer.  63:406-413.

14.  Gerlach, RW, Gambosi, JR, Bowen, RH. 1990, Cancer Survivors'
Needs Reported by Survivors and their Families.  Journal of Cancer
Education. 5:1, 63-70.

15.  Marshall, PA. 1990, Cultural Influences on Perceived Quality of
Life. Seminars in Oncology Nursing 6:4, 278-284.

16.  Osoba, D. 1991, Effect of Cancer on Quality of Life.  CRC Press,
Inc. Boston, MA.

17.  Spiker, B. 1990, Quality of Life Assessments in Clinical Trials.
Raven Press, New York.

18.  Wilkin, D., Hallan, L., Doggett, M. 1992. Measures of need and
outcome for Primary Health Care.  Oxford University Press, Oxford.

19.  Heithoff, KA, Lohr, KN, eds, 1990.Effectiveness and Outcomes in
Health Care. Washington, DC, National Academy Press.

.

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