DIET, LIFESTYLE AND CANCER IN U.S. SPECIAL POPULATIONS

Release Date:  February 23, 1998

PA NUMBER:  PA-98-028

P.T.

National Cancer Institute

PURPOSE

The Division of Cancer Control and Population Sciences of the National Cancer
Institute (NCI) invites grant applications for epidemiologic studies to
elucidate causes of cancer and means of prevention in African Americans,
American Indians, Alaska Natives, Asian and Pacific Islanders, Native
Hawaiians, Hispanics, rural, older, low income and low-literacy groups.  These
groups experience unusually high cancer incidence and mortality for some
cancer sites.

The reasons for the disparate rates may be differences in environmental
exposures, socioeconomic factors, modifiable behavioral risk factors (such as
diet, smoking, alcohol intake and physical activity), access and utilization
of screening, treatment and rehabilitation services, and the presence of
inherited susceptibilities.  Furthermore, changing demographics in the U. S.,
revolutions in communications and informatics, and health care management
coupled with explosive growth in molecular biology research open up vast new
areas for research, the success of which will require multidisciplinary
efforts.

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 Program Announcement (PA) is
related to the priority area of cancer in minorities. and underserved
populations.  Potential applicants may obtain a copy of "Healthy People 2000"
(Full Report: Stock No. 017-001-00474-0 or 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 or local Government, and eligible
agencies of the Federal Government, and small businesses.  Foreign
institutions are not eligible for program project (P01) grants.  Racial/ethnic
minority individuals, women and persons with disabilities are encouraged to
apply as Principal Investigators.

MECHANISM OF SUPPORT

Support of this program will be through the National Institutes of Health
(NIH) program project  grant (P01) and traditional research project grant
(R01).  Applicants will be responsible for the planning, direction, and
execution of the proposed project.

Applicants requesting budgets greater than $500,000 in direct costs are
required to contact program staff in the appropriate NIH institute prior to
submitting their applications (NIH GUIDE, Vol. 25, No. 14, May 3, 1996).
Applicants with budget of more than $500,000 in direct costs that are
submitted without prior communication with NIH program staff will not be
accepted for review.

Prospective applicants are encouraged to discuss their ideas with NCI program
staff listed under INQUIRIES.

RESEARCH OBJECTIVES

Background

Cancer incidence varies widely among racial and ethnic groups around the
world.  The diversity of the US population offers unique opportunities for
epidemiologic studies of cancer etiology in various ethnic/minority and
underserved populations.  A recently prepared monograph on "Racial/Ethnic
Patterns of Cancer in the United States 1988-1992" published by the
Surveillance, Epidemiology and End Results Program of the National Cancer
Institute reveals strikingly varying cancer rates across population subgroups 
(1).

Overall, age-adjusted cancer incidence rates are higher in men, ranging from
196 for American Indians (New Mexico) to 560 for African Americans per 100,000
population.  In women, cancer incidence rates range from 180 for American
Indians (New Mexico) and Koreans to 354 for White Non-Hispanic women per
100,000 population (Table 1).

Epidemiologic studies of secular trends in cancer incidence and of cancer
patterns among migrants suggest environmental factors as the major
determinants of cancer risk.  Higgins and Muir (2) attributed over 85% of the
cancer burden to exogenous exposures.  However, to date, only cigarette
smoking has been established clearly as a major risk factor for cancer. 
Several other causes of cancer are known, including ultraviolet and ionizing
radiation, certain drugs, infectious agents such as hepatitis B virus and
human papillomavirus, and exposure to certain chemicals in the occupational
environment (3).  The contributions of these non-smoking exposures to the
total cancer burden in the U S. appear to be relatively small.  Doll and Peto
(4) estimated that dietary factors are responsible for about one-third of all
cancers in the U.S.

Epidemiologic studies have provided clues about the influence of environmental
exposures and cultural/lifestyle factors in cancer causation.  However, the
specific role of dietary practices and nutritional status in host
susceptibility needs to be clarified.  Diet may influence cancer risk in a
number of ways: through exposure to carcinogens as food contaminants; through
the formation of carcinogens during the storage, processing or cooking of
foods; through carcinogens produced in vivo from ingested food; through the
protective effect of certain dietary components and through effects from under
nutrition on the immune system.  It is unknown whether dietary interactions
with other exposures, such as cigarette smoke or occupational substances,
influence cancer development.

Research Scope and Goals

The purpose of this program announcement is to stimulate epidemiologic studies
of cancer etiology and behavior in special populations of the US.  Innovative
approaches that involve inter-disciplinary collaborations of basic, behavioral
or clinical researchers with epidemiologists are encouraged.  Whenever
possible, studies should make cost-efficient use of existing resources, such
as population-based cancer registries or specimen repositories.

The initiative permits a wide range of epidemiologic investigations of cancer
in US special populations.  The areas of research listed below are not
intended to be all-inclusive, but are designed to give the applicant some
direction for the types of research that the NCI is interested in stimulating
to enhance knowledge about the etiology of various cancers and means for their
prevention.

1.  Cross-cultural studies of cancers with striking ethnic disparities in
incidence rates, among  groups residing in the same or different geographic
areas, to identify more specifically the etiologic factors and to study their
relationships with biomarkers of exposure.

2.  Analytic studies of specific cancer sites to determine the impact of age-
specific changes in exposure over time, due to waves of migration within the
US as well as from other countries, and/or secular changes in lifestyle,
occupation and environment.

3.  Studies of ethnic differences in the histologic and cytologic parameters
of particular cancers that may reflect differences in exposures or
susceptibility.

4.  Studies addressing methodological issues related to the heterogeneity of
ethnic groups, especially dietary and genetic parameters.

5.  Molecular epidemiologic studies exploring differences in genetic
predisposition to cancer due to variations in carcinogen metabolism, DNA
repair activities, response to tumor promoters, measures of immune function,
chromosome sensitivity to mutagens, or other factors.

6.  Development and validation of instruments for assessing diet and lifestyle
factors such as smoking, alcohol intake and exercise and their role in the
risk of cancer among understudied special populations.

7.  Studies among Hispanics with special consideration given to the assessment
of Hispanic ethnicity within the study population.

8.  Feasibility studies to establish cohorts of Native Americans for
elucidating causes of illness and assessing influence of lifestyle changes on
disease risk.

9.  Studies exploring culturally sensitive and socioeconomically sensitive,
appropriately tailored approaches for dietary modification, monitoring
compliance via appropriate means, to assess cancer risk in U. S. special
populations.

10.  Studies of motivational and behavioral strategies, including use of
adjuncts, on diet modification and other lifestyle changes.

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).

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.

APPLICATION PROCEDURES

Applications are to be submitted on the research grant application form PHS
398 (rev. 5/95) and will be accepted on the standard 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, email: ASKNIH@od.nih.gov.  The title and number of the program
announcement must be typed in line 2 of the face page of the application and
the YES box must be marked.

It is strongly recommended that P01 applicants follow the instructions
contained in the Program Project Guidelines of the National Cancer Institute
booklet.  Copies of the Guidelines are available from the NCI Referral Officer
at the address listed below.

The completed original application and five legible copies of the R01
application or three legible copies of the P01 application must be sent or
delivered to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

Send two additional exact photocopies of the program project (P01) application
to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6130 Executive Boulevard, Room 636, MSC-7407
Bethesda, MD  20892-7407
Telephone:  (301) 496-3428
FAX:  (301) 402-0275
Email:  Friedbergt@dea.nci.nih.gov

REVIEW CONSIDERATIONS

Traditional research project grant (R01) applications will be assigned on the
basis of established Public Health Services 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, assigned a priority
score, and receive a second level review by the appropriate national advisory
board or council.

Applications must be sufficiently complete so that they can be reviewed
without a site visit.

Review Criteria

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 discuss the following aspects of the application to assess 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 in assigning the overall score, weighting them as appropriate for
each application.  The application does not need to be strong in all
categories to be judged likely to have a major scientific impact.  For
instance, the proposed research may not be innovative but is essential to move
a field forward. The review criteria are:

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 strategies?

3.  Innovation: Does the project employ novel concepts, approaches or methods? 
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?

In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:

6.  Adequacy of plans to include both genders, and minorities and their
subgroups as appropriate for the scientific goals of the research.  Plans for
the recruitment and retention of subjects will also be evaluated.

7.  The adequacy of the proposed provisions for the protection of human
subjects and animal welfare and the safety of the research environment.

8.  The reasonableness of the proposed budget and duration in relation to the
proposed research.

Additional Review Criteria for P01 Applications:

The R01 review criteria listed above apply to P01 applications.  In addition,
potential applicants should contact the NCI Referral Officer listed under
APPLICATION PROCEDURES for detailed information on P01 review guidelines.

AWARD CRITERIA

Applications will compete for available funds. The following will be
considered in making funding decisions: quality of the proposed project as
determined by peer review, availability of funds, and program balance and
priority.

INQUIRIES

Inquiries are encouraged, particularly during the planning phase of the grant
applications. The opportunity to clarify any issues or questions from
potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Dr. A.R. Patel
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, Suite 535, MSC 7395
Bethesda, MD  20892-7395
Telephone:  (301) 496-9600
FAX:  (301) 402-4279
Email:  Patela@epndce.nci.nih.gov

Direct inquiries regarding fiscal matters to:

Mr. Bill Wells
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Suite 243, MSC 7150
Bethesda, MD  20892-7150
Telephone:  (301) 496-7800, ext 250
FAX:  (301) 496-8601
Email:  Wellsw@gab.nci.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.393.  Awards are made under authorization of the Public Health Service Act,
Title IV, Part A (Public Law 78-140, as amended by Public Law 99.158, 42
U.S.C. 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 PHS strongly encourages all grant recipients to provide a smoke-free
workplace and promote the non-use of all tobacco products.  In addition,
Public Law 103-227, The Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care or early childhood
development services are provided to children.  This is consistent with the
PHS mission to protect and advance the physical and mental health of the
American people.

References

1.  Racial/ethnic patterns of cancer in the United States 1988-1992.  NIH
Publication 96-4104, April 1996.

2.  Higginson, J. and Muir, C.S., Environmental carcinogenesis: misconceptions
and limitations to cancer control.  J. Natl. Cancer Inst., 63, 1291-1298,
1979.

3.  Schottenfeld, D. and Fraumeni, J.F., Jr., Cancer epidemiology and
prevention 2nd edition, 1996 Oxford  University Press, New York, 1996.

4.  Doll, R. and Peto, R., The causes of cancer: quantitative estimates of
available risks of cancer in the United States today. J. Natl. Cancer Inst.,
66, 1191-1308, 1981.

Table 1

ALL CANCERS COMBINED: SEER INCIDENCE RATES 1988-1992

Men                       Rate         Women                     Rate
African American          560          White, Non-Hispanic       354
White, Non-Hispanic       481          Alaska Native             348
Alaska Native             372          African American          326
Hawaiian                  340          Hawaiian                  321
White Hispanic            336          Vietnamese                273
Vietnamese                326          White Hispanic            256
Japanese                  322          Hispanic (total)          243
Hispanic (total)          319          Japanese                  241
Chinese                   282          Filipino                  224
Filipino                  274          Chinese                   213
Korean                    266          Korean                    180
Amer. Indian (NM)         196          Amer. Indian (NM)         180

Note: rates are average annual per 100,000 population, age-adjusted to 1970 US
standard

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