Full Text PA-97-055
 
PRIORITIES IN BEHAVIORAL RESEARCH IN CANCER PREVENTION AND CONTROL
 
NIH GUIDE, Volume 26, Number 13, April 18, 1997
 
PA NUMBER: PA-97-055
 
P.T. 34

Keywords: 
  Cancer/Carcinogenesis 
  Behavioral/Social Studies/Service 
  Disease Prevention+ 

 
National Cancer Institute
National Institute of Dental Research
 
PURPOSE
 
The National Cancer Institute (NCI), and the National Institute of
Dental Research invite researchers to submit research grant
applications which address behavioral research issues in cancer
prevention and control.  This Program Announcement (PA) addresses
recommendations made by a special Behavioral Research in Cancer
Prevention and Control Working Group in 1996 which consisted of
leading national experts whose role was to identify behavioral
research needs in cancer prevention and control during the coming
years.
 
This multi-disciplinary Working Group reviewed and refined the series
of recommendations for priorities in behavioral research which was
generated at a 1995 meeting.  Members were asked to consider the
successes and failures of behavioral research in the past decade, as
well as the emerging challenges posed by scientific advances and
changes in health care delivery.  The recommendations that were
generated based on these considerations and on the following
criteria: (1) strength of the scientific evidence, (2) potential for
reducing the cancer burden, (3) responsiveness to opportunities
arising from advances in basic science and technology, (4)
availability of technologies, (5) feasibility of implementation, and
(6) achievable and measurable goals and outcomes. The full copy of
the Report of the Working Group: Priorities in Behavioral Research in
Cancer Prevention and Control can be obtained from the National
Cancer Institute, EPN, Suite 232, 6130 Executive Blvd MSC 7330,
Bethesda, Maryland 20892- 7330; Phone (301) 496-8520; or via the
Internet: http://www.dcpc.nci.nih.gov/PCEB/research/
 
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 PA,
Cancer Prevention and Control Research Small Grant Program, is
related to the priority areas of cancer, nutrition and tobacco.
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, D.C. 20402-9325
(telephone (202) 512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic and foreign, for- profit
and nonprofit organizations, public and private, such as
universities, colleges, hospitals, laboratories, units of State and
local governments and eligible agencies of the Federal government.
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.
 
MECHANISM OF SUPPORT
 
Support for this research will be through the NIH research project
grant (R01) award. Responsibility for the planning, direction, and
execution of the proposed research will be solely that of the
applicant.
 
RESEARCH OBJECTIVES
 
Background
 
Behavioral research is central to the prevention, early detection,
and control of cancer.  Approximately 65% of cancer deaths are
attributable to behaviors such as smoking and diet (e.g., excess fat
and inadequate fiber intake) (Doll & Peto, 1981).  Use of smokeless
tobacco or the exposure of oral tissues to the combined effects of
smoked or smokeless tobacco and alcohol may account for up to 80% of
oral cancers. Efforts to modify these and other behaviors have led to
a reduction in the U.S. cancer burden.  For example, since 1965, the
proportion of Americans who smoke has decreased from 52% to 26%
(Centers for Disease Control and Prevention, 1994a), and lung cancer
rates in men have declined (Devesa et al., 1995).  In addition, an
increased understanding of barriers to cancer screening has made it
possible to develop effective strategies to promote adherence to
breast and cervical cancer screening (Hiatt, in press), although
barriers to oral cancer screening in the dental office have received
considerably less attention from researchers.  Although neither
correlations nor causation can be attributed, from 1987-1992, the
period in which behavioral interventions increased substantially, the
proportion of NHIS respondents who reported a recent mammogram
increased at least twofold for women in every age and ethnic group
(Breen & Kessler, 1996).  Behavioral research has also made major
contributions to our knowledge of individual and treatment-related
variables that impact on quality of life in persons with cancer.
This knowledge has been translated into effective psychosocial and
behavioral interventions to reduce cancer pain, enhance quality of
life, and in some cases, prolong survival (Fawzy et al., 1995).
 
Despite these successes, important needs for behavioral research
remain (Greenwald, in press).  While overall smoking rates and
mortality have declined in men, these rates have increased in women,
in minorities, and most alarmingly, in children and teenagers
(Centers for Disease Control and Prevention, 1994b, 1995; Johnston et
al., 1995).  There is also a need to develop effective treatments for
heavily nicotine dependent smokers and smokeless tobacco users who
have been least responsive to smoking cessation interventions.
Despite evidence for the health benefits of fruit and vegetable
consumption, only 23% of U.S. adults eat 5 or more servings of fruits
and vegetables a day (Subar et al., 1995).  In addition, avoidable
mortality from breast, cervical and oral cancers can be reduced
further by increasing adherence to screening, particularly among
persons of low socio-economic status (Hiatt, in press).  Rates of
adherence to recommendations for colon cancer screening remain
extremely low in all adults over age 50. To have optimum impact,
behavioral research must also respond to new opportunities and
challenges resulting from advances in basic science and technology
and from changes in healthcare delivery.  Breakthroughs in cancer
genetics have created unprecedented opportunities for individuals to
learn whether they carry mutations in cancer-predisposing genes. As
yet, however, little is known about how to communicate this
information in a way that will facilitate informed decision-making
and minimize potential adverse psychosocial effects.  Additional
challenges to risk communication and informed consent are posed by
the application of new screening tests with unproven benefits and
possible risks (e.g., PSA) and by controversial medical
recommendations (e.g., mammography for women in their 40's, estrogen
replacement therapy for women who had breast cancer).  Behavioral
research can also make important contributions to our understanding
of how cancer prevention and control interventions can be integrated
successfully and efficiently into emerging models of primary
healthcare delivery, such as managed care (Kaluzny, in press).
 
Ultimately, the successful application of new knowledge from basic,
clinical, and cancer control research will depend on the behavior of
the public, patients, and health professionals. Thus, it is
essential that the National Cancer Institute (NCI) support a strong
program of behavioral research with collaboration across Divisions.
 
Research Issues
 
Examples of priority areas for behavioral research in cancer
prevention and control areas which might be addressed by applicants
are listed below.  The list is illustrative rather than
comprehensive.  It is expected that additional relevant and important
research topics will be identified by investigators responding to
this announcement.
 
1.  Prevention and Cessation of Smoked and Smokeless Tobacco Use
among Children, Teenagers, and Adults: Children and teenagers are at
significant risk to become regular smokers (Glynn et al., 1993).
Overall, 19% of high school seniors are daily smokers, and there has
been little change in this proportion for the last 10 years (Johnston
et al., 1995). The reduction of adult use of tobacco has also slowed
considerably in recent years (Centers for Disease Control, 1996). New
efforts are therefore needed to identify determinants of smoking
initiation and maintenance in U.S. youth and, especially, to design
and evaluate innovative strategies to reduce the prevalence of this
high risk behavior among both youth and adults.
 
2.  Enhancing Risk Communication, Comprehension, and Informed
Decision-Making Under Uncertainty: As new technologies are integrated
into mainstream medical and dental care, patients are being
challenged to make difficult decisions in the face of uncertain risks
and benefits.  Examples include prostate specific antigen (PSA),
mammography for women in their 40's, colorectal screening, genetic
susceptibility tests, and investigational treatments offered to
patients with late-stage cancer.  While people tend to overestimate
their personal risks of cancer, there are circumstances in which
significant under-estimation of risk and over-valuation of medical
intervention occurs.  This can lead to inappropriate use of
diagnostic and treatment technologies.  Research is needed to design
and evaluate strategies to improve cancer risk communication, enhance
comprehension, and facilitate informed decision-making about options
for cancer prevention, screening and treatment (Rimer, 1995).  This
priority is consistent with the 1989 recommendations of the National
Research Council which identified risk communication research as an
important priority area (National Research Council, 1989).
 
3.  Integrating Preventive and Early Detection Services into Changing
Health Delivery Systems: The proportion of the insured population
covered by a managed care arrangement has increased from 47% in 1991
to 65% in 1994, and continues to rise steadily (Eckholm, 1994).
Increasingly, primary care providers, and physicians in particular,
are becoming part of larger organizations.   Over three-fourths of
physicians now participate in managed care (Emmons & Simon, 1994).
Behavioral research must respond to this change in healthcare
delivery by designing and testing innovative cancer prevention and
control interventions that can be integrated into healthcare systems
in a cost-effective manner.  Also, research directed toward health
care providers, such as dentists, who deliver care in predominantly
solo practice settings, is still needed to test innovative approaches
to improve dissemination/adoption of up-to-date approaches in oral
cancer prevention and detection, including appropriate dental
office-based screening, identification of risk factors, and referral.
 
4.  Improving the Outcomes of Genetic Testing for Cancer
Susceptibility: Breakthroughs in cancer genetics have created
unprecedented opportunities for individuals to learn whether they
carry mutations in cancer-predisposing genes.  These include rare
cancer genes that confer an 80- 90% lifetime cancer risk (e.g.,
BRCA1) as well as more common, but less penetrant, genes that
interact with environmental and lifestyle factors (e.g., CYP2D6).
Genetic information has potentially far-reaching consequences for the
psychological well-being and medical care of individuals at high risk
for cancer (Lerman et al., 1996).  A better understanding of the
behavioral and social impact of disclosure of genetic information is
critical to designing optimal education and counseling approaches.
Efforts are also needed to evaluate behavioral interventions to
enhance quality of life and maximize adoption of cancer control
practices among participants in genetic testing programs.
 
5.  Enhancing Survivorship of Cancer Patients:  Due to advancements
in early detection and treatment, people are living longer with
cancer, dramatically increasing the number of cancer- affected
life-years in our nation.  There are now over eight million cancer
survivors in the U.S.  This raises the question of the quality of
that extended survival time, including its effect upon productivity,
family functioning, and both medical and psychiatric comorbidity
(Lewis, in press). Behavioral and psychosocial interventions are
needed to enhance functional health status (e.g., return to work),
improve the delivery of palliative care, and promote health behaviors
that may reduce the risk of second malignancies.
 
6.  Promoting a Healthy Diet and Physical Activity: Nutrition and
physical activity play a central role in the initiation, promotion,
and progression of cancer.  U.S. guidelines recommend diets that are
low in fat and high in fiber, fruits, and vegetables.  Yet, only a
small proportion of the U.S. population adheres to recommended
guidelines for diet or participates in regular physical activity
(Glanz, in press). Efforts are needed to examine the determinants of
changes in these behaviors  and to design innovative interventions,
particularly those that can be targeted to populations at high risk
for cancer.
 
Cross-Cutting Themes
 
The following are relevant to all areas of priority behavioral
research, and therefore, are strongly encouraged as cross- cutting
themes to be considered in applications prepared in response to this
Program Announcement.
 
1.  Consideration of Race, Social Class, and Culture: To have the
broadest impact on cancer morbidity and mortality, behavioral
research must take into account the racial, cultural, and
socioeconomic factors that influence adoption of cancer prevention
and control practices.  This is especially true since, for example,
education and income are key predictors of cancer screening (Breen &
Kessler, 1994). Special efforts are required to enroll these
population subgroups into cancer prevention and control studies.
There is a need to examine healthcare financing and utilization
patterns to broaden our understanding of how barriers and incentives
operate in underserved populations.  Interventions and measurement
tools that are practical and culturally appropriate are encouraged.
 
2.  Theory-Driven Research: There is a need to expand existing
theories of health behavior to take account of underserved
populations, new healthcare technologies, and changes in service
delivery.  Cognitive and emotional variables (e.g., risk perception,
distress), which receive insufficient attention in the dominant
models of health behavior, need to be addressed (Glanz, Lewis, &
Rimer, in press).  Researchers are encouraged to use theory both to
guide intervention development and to test hypotheses about
mechanisms of intervention impact.
 
3.  Multiple Level Interventions Targeted to Multiple Risk Factors:
Cancer control interventions are likely to be most effective if aimed
at multiple levels, including  individuals, families, healthcare
providers, and organizations.  This could involve systemic changes
such as broad policies and social norms. Wherever possible, multiple
risk factors and health behaviors should be targeted by interventions
in order to achieve the maximal benefit for the lowest cost.
Hypothesis- driven interventions delivered in primary care settings
and those which address public policy change are particularly
important.
 
4.  Research Settings:  Behavioral research initiatives should span
all phases of cancer control research and take place in a variety of
settings.  For example, basic behavioral research and longitudinal
(non-intervention) studies in clinical settings are likely to be
necessary in research areas that are relatively new (e.g., genetic
testing, informed decision- making).  For areas in which a
considerable body of research is already available (e.g., smoked or
smokeless tobacco use, screening adherence), it is anticipated that
interventions addressing systemic change would be  recommended.  In
these areas, research in community settings would be especially
important.  However, basic behavioral research in all areas of cancer
control will be valuable to foster continued improvements in
interventions.
 
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 form
the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43).
 
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, Vol. 23, No. 11, March 18, 1994.
 
APPLICATION PROCEDURES
 
Applications are to be submitted on the grant application form PHS
398 (rev. 5/95) and will be accepted at the standard application
deadlines as indicated in the application kit. 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, MSC
7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, e-mail:
[email protected], and the program administrator listed
under INQUIRIES.  The title and number of the program announcement
must be typed in Section 2 on the face page of the application.
Following presentation of the research plan, include the discussion
of Human Subjects and the literature cited.
 
The completed original application and five copies must be sent or
delivered to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD  20892
BETHESDA, MD  20817 (for express/courier service)
 
REVIEW CONSIDERATIONS
 
Applications will be assigned on the basis of established PHS
referral guidelines.  Applications that are complete will be
evaluated for scientific and technical merit by an appropriate peer
review group convened in accordance with the standard NIH peer review
procedures.  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 applications under review, will be
discussed,  and assigned a priority score, and receive a second level
review by the appropriate National Advisory Council or Board.
 
Review Criteria
 
1.  scientific, technical, or medical significance or originality of
proposed research;
 
2.  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;
 
3.  qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;
 
4.  availability of the resources necessary to perform the research;
 
5.  appropriateness of the proposed budget and duration in relation
to the proposed research.
 
The initial review group will also examine the provisions for the
protection of human and animal subjects, the safety of the research
environment, and conformance with the NIH Guidelines for the
Inclusion of Women and Minorities as Subjects in Clinical Research.
 
AWARD CRITERIA
 
Applications will compete for available funds with all other approved
applications.  Funding decisions will be based upon quality of the
proposed project as determined by peer review, availability of funds,
and program balance among research areas of the announcement.
 
The National Institute of Nursing Research (NINR) has an interest in
behavioral research in cancer prevention and control.  Applications
that are of mutual interest may be given assignment to NINR in
accordance with the NIH referral guidelines.  Contact Dr. June R.
Lunney, Division of Extramural Activities, NINR, telephone
301/594-6908, FAX 301/480-8260, email [email protected].
 
INQUIRIES
 
Inquiries are encouraged.  Direct inquiries regarding programmatic
issues to:
 
Ms. Veronica Chollett
National Cancer Institute
6130 Executive Boulevard, Room 232 - MSC 7330
Bethesda, MD  20892-7330
Telephone:  (301) 435-2837
Email:  [email protected]
 
Dr. Patricia Bryant
Behavior, Health Promotion, and Environment Program
National Institute of Dental Research
45 Center Drive, Room 4AN24E
Bethesda, MD  20892
Telephone:  (301) 594-2095
Email:  [email protected]
 
Inquiries regarding fiscal matters may be directed to:
 
Mr. Mark Hodor
National Cancer Institute
Executive Plaza North
6120 Executive Boulevard, Room 243
Bethesda, MD  20892
Telephone:  (301) 496-7800 ext 215
Email:  [email protected]
 
Mr. Martin R. Rubinstein
National Institute of Dental Research
45 Center Drive, Room 4AN44A
Bethesda, MD  20892
Telephone:  (301) 594-4800
FAX:  (301) 480-8301
Email:  [email protected]
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.399.  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 grant 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.
 
The PHS strongly encourages all grant and contract 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
 
Breen, N. and Kessler, L.  Changes in the use of screening
mammography: Evidence from the 1987 and 1990 National Health
Interview Surveys.  American Journal of Public Health, 1994, 84(1),
62-67.
 
Breen, N. and Kessler, L.  Trends in cancer screening United States,
1987 and 1992.  Morbidity and Mortality Weekly Report, 1996, 45(3),
57-61.
 
Centers for Disease Control and Prevention.  Cigarette smoking among
adults United States, 1993.  Morbidity and Mortality Weekly Report,
1994a, 43(50), 925-930.
 
Centers for Disease Control and Prevention.  Surveillance for
selected tobacco-use behaviors United States, 1900-1994. Morbidity
and Mortality Weekly Report, 1994b, 43(SS-3), 1-33. Centers for
Disease Control and Prevention.  Trends in smoking initiation among
adolescents and young adults.  Morbidity and Mortality Weekly Report,
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Devesa, D.S., Blot, W.J., Stone, B.J., Miller, B.A., Tarone, R.E.,
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Eckholm, E.  RWhile Congress Remains Silent, Health Care Transforms
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Emmons, D.W., and Simon, C.J.  RRecent Trends in Managed CareS.  In
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Glanz, K., Lewis, F.M., and Rimer, B.K. (Eds).  Health Behavior and
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Glynn, T.J., Greenwald, P., Mills, S.M., and Manley, M.W.  Youth
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Greenwald, P.  Consequential behavioral research and cancer
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Lerman, C., Narod, S., Schulman, K., Hughes, C., Gomez- Caminero, A.,
Bonney, G., Gold,  K., Trock, B., Main, D., Lynch, J., Fulmore, C.,
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Lynch, H.  BRCA1 testing in families with hereditary breast-ovarian
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Lewis, F.M.  Behavioral research to enhance adjustment and quality of
life in adults with cancer.  Preventive Medicine, in press.
 
National Research Council.  Improving Risk Communication. Washington,
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703-704.
 
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Pivonka, E., and Kessler, R.  Fruit and vegetable intake in the
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Publication No. (PHS) 91-50212. Washington, DC: U.S. Government
Printing Office, 1991.
 
.

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