EDUCATIONAL INTERVENTION RESEARCH ON CANCER RISK REDUCTION FORHIGH-RISK YOUTH



NIH GUIDE, Volume 23, Number 2, January 14, 1994



PA NUMBER:  PA-94-027



P.T. 34, AA



Keywords:

  Cancer/Carcinogenesis 

  05020170411005 



National Cancer Institute



PURPOSE



The National Cancer Institute (NCI) invites applications for studies

to develop, evaluate, and disseminate effective cancer risk reduction

methods and materials for high-risk youth.  This population is here

defined as children or adolescents aged 1 to 18 years who are from

low socioeconomic status households or communities.



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,

Educational Intervention Research on Cancer Risk Reduction for

High-Risk Youth, is related to the priority areas of tobacco,

nutrition, alcohol, HIV infection, and general cancer prevention.

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 foreign and domestic, non-profit and

for-profit organizations and by public and private entities such as

universities, colleges, hospitals, laboratories, units of state or

local governments, and eligible agencies of the Federal government.

Applications from minority and women investigators are encouraged.

Foreign institutions are not eligible for First Independent Research

Support and Transition (FIRST) (R29) awards.



MECHANISM OF SUPPORT



Grant mechanisms include Research Project Grants (R01); and FIRST

(R29) awards.  Awards will be administered under the PHS grants

policy as stated in the PHS Grants Policy Statement.  It is

anticipated that size of awards will vary based on nature and scope

of proposed research.



RESEARCH OBJECTIVES



It is estimated that more than 20 percent of all American children

under 18 years of age live in poverty.  Included in this group are

approximately 15 percent of all White children, 40 percent of all

Hispanic children, and 45 percent of all Black children.  These young

people are extremely vulnerable to several cancer causing behaviors.

Children of poverty often experiment with or are regular users of

tobacco or alcohol, are sexually active without the benefits of

barrier protection, and have nutritional habits that are unhealthy.

Many of these young people live in a world where adult guidance is

inadequate, and where the social and institutional environment

challenges rather than nurtures development.  From a public health

perspective, the effects of these conditions are at least two-fold:

first, they make programmatic efforts especially difficult to

implement, frequently causing impoverished youth to become

underserved and hard-to-reach; and second, these conditions

predispose children to health-compromising behaviors, thus making

them 'high-risk'.



Most experts agree that high-risk youth are typified by several

characteristics: they are often economically disadvantaged, the

children of substance abuser parents, and/or the victims of physical,

sexual, or emotional abuse; they have experienced chronic failure in

school or have dropped out of school; and they have had mental health

problems, attempted suicide, or committed violent or delinquent acts.



An NCI Expert Advisory Panel considered those youth who are

economically disadvantaged, come from dysfunctional families, have

little or no parental supervision, have family members or peers who

are substance users, have non-substance related deviant behaviors,

have low educational achievement and/or aspirations, have experienced

chronic school failure or have dropped out of school, or are members

of minority or ethnic groups, to be at highest risk and in most need

of targeted programs.



While any or all of these characteristics, particularly lack of

commitment to education, are important predictors of high-risk

behavior, the single most influential antecedent is poverty.  Thus,

for the purposes of this PA, the following serves as a working

definition of high-risk youth:  children or adolescents aged 1 to 18

years who are living in low socioeconomic status households or

communities.  The exact dollar amount of this status is usually

determined locally, but may be derived through average income by

census tract, high unemployment by census tract, family eligibility

for medicaid, eligibility for school breakfast programs or lunch

supplements, or as defined in each local jurisdiction.



This PA has two major research objectives related to the high-risk

youth population:  1) to develop and conduct educational

interventions to reduce cancer risks associated with tobacco use,

poor dietary choices, alcohol use, and early, unprotected sexual

activity among high-risk youth; and 2) to design and conduct

randomized controlled studies among a representative sample of

high-risk youth to determine the knowledge, attitude, and behavioral

effects of these educational interventions.



Behaviors related to these risk conditions may lead to cancer in

several sites.  Tobacco use, the single most important and

preventable cause of cancer mortality in the U.S., is associated with

cancers of the lung, lip, mouth, tongue, pharynx, larynx, esophagus,

bladder, kidney, prostate, pancreas, and uterine cervix.  More than a

third of all cancers in this country may be related to excessive fat

consumption and inadequate fiber consumption.  Alcohol consumption

increases the risk of cancers of the mouth, pharynx, larynx, and

esophagus, particularly when combined with smoking.  Unprotected

sexual activity has been linked to Burkitt's lymphoma (Epstein-Barr

virus), cancer of the uterine cervix (herpes simplex type 2 and human

papilloma virus), liver cancer (hepatitis B virus), as well as

non-Hodgkin's lymphoma and other cancers associated with the AIDS

(human immunodeficiency syndrome) virus.  These behaviors are

changeable, and the cancers associated with them are preventable.



Previous interventions targeted to middle-class populations of youth

have been shown to be effective in increasing health knowledge,

developing health enhancing attitudes, and causing changes in

behavior, particularly when delivered through schools and other

community-level organizations.  Unfortunately, many poor and

underserved children have limited exposure to classroom health

education or neighborhood programs.  Few studies have demonstrated

effective school-based prevention strategies for low-income

adolescents, and there is a noticeable lack of proven community

interventions that specifically target low socioeconomic populations

and ethnic minorities.  More research is needed, for instance, on the

effects of culturally appropriate intervention models emphasizing

cultural pride and history, and the use of ethnically matched staff

and peer educators.  Also, since clearly not all low socioeconomic

status children engage in high risk behaviors, there must be

antecedents to risk avoidance. The premise of this PA is that there

are factors that predispose, enable, and reinforce health status,

that they are identifiable, and that they may be used in a variety of

risk reduction interventions for populations of high-risk youth.



Interventions should be based on appropriate behavioral,

developmental, and educational scientific theories.  They should also

be built on the results of previous strategies shown to be

efficacious in changing risk factors related to knowledge, attitudes,

and behaviors, especially in populations of adolescents.

Intervention sites may include community health centers, the juvenile

justice system, community youth organizations, or schools.

Investigators will be required to give full details of how they

intend to accomplish their evaluation, and explain how they will

recruit and track what is likely to be a hard-to-reach population.

Interventions should use a variety of culturally sensitive approaches

rather than a single approach, and should be adapted to the special

needs of high-risk youth to provide them with skills to make their

own decisions to refrain from unhealthy behaviors in spite of peer,

advertising, and other pressures endemic to their social environment.



Projects will consist of intervening and measuring change in a sample

drawn from a population of 1 to 18 year olds shown to be of low

socioeconomic or other high-risk status by the investigator.

Projects will usually include pilot testing survey instruments and

techniques for feasibility and acceptability, validating instruments,

assessing participation and adherence rates, and adapting materials

to cultural sensitivities. Investigators may develop their own, or

select from or adapt existing materials or strategies that have been

shown to be effective in reducing cancer risks.  Techniques for

validating effectiveness of methods and materials will also be the

responsibility of investigators.



To ensure results that are representative, investigators will be

required to randomly assign individuals or groups to treatment and

comparison conditions, and to practice the accepted methods of social

science and quasi-experimental research.  Experimental groups should

be matched on socioeconomic status, age, sex, ethnicity, current or

past behavioral risk factors, and other relevant variables.

Experimental groups must also be of sufficient size to provide the

statistical power necessary to detect significant differences between

groups on variables of interest.



Both outcome and process evaluations should take place under this PA.

While outcome evaluation is justifiably seen as evidence of the

degree to which an intervention was successful in helping to

ultimately reduce morbidity and mortality, process evaluation should

be regarded as equally important in this research because of the need

to know more about how to conduct interventions with high-risk

populations.



Outcome evaluations should be designed to provide quantitative

answers to questions such as:  to what degree was tobacco use onset

prevented, and tobacco use decreased; to what degree did fruit and

vegetable consumption increase, and fat consumption decrease; to what

degree was alcohol use onset prevented, and alcohol consumption

decreased; to what degree did the age of onset of sexual activity

increase, and to what degree did unprotected sexual activity

decrease?



Process evaluations should be designed to provide quantitative, and

where informative, qualitative answers to questions such as: what are

the successful elements of prevention programs for high-risk youth;

what are the culturally specific or special needs of these

populations, and how can programs be made sensitive to their needs;

what role can non-school channels play in reaching these youth; how

were community organizations recruited; how were high-risk youth

recruited; and to what extent was the program adopted by the

institution in which it was implemented?



STUDY POPULATIONS



SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH

POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

RESEARCH STUDY POPULATIONS



National Institutes of Health (NIH) policy is that applicants for NIH

clinical research grants 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 should be placed on the inclusion of

minorities and women in studies of diseases, disorders and conditions

that 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 should be provided.



The composition of the proposed study population must be described in

terms of gender and racial or ethnic group, together with a rationale

for its choice.  In addition, gender and racial or ethnic issues

should be addressed in developing a research design and sample size

appropriate for the scientific objectives of the study.  This

information should be included on grant application 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 carefully assess

the feasibility of including the broadest possible representation of

minority groups.  However, 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 or 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 includes human

biomedical and behavioral studies or 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,

applicants 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,

review will be deferred until the information is provided.



Peer reviewers will specifically address 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 a priority score to the application.



All applications for clinical research submitted to NIH are required

to address these policies.  NIH funding components will not award

grants that do not comply with these policies.



APPLICATION PROCEDURES



Applications are to be submitted on form PHS 398 (rev. 9/91) and will

be accepted at the standard applications deadlines as indicated in

the application kit.  The receipt dates for applications for

AIDS-related research are found in the PHS 398 (rev. 9/91)

instructions.



Application kits are available at most institutional offices of

sponsored research and may be obtained from the Office of Grants

Information, Division of Research Grants, National Institutes of

Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone

(301) 435-0714.  The title and number of this PA must be typed on

Line 2a on the face page of the application.



The completed original application and five legible copies must be

sent or delivered to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



REVIEW CONSIDERATIONS



Applications will be assigned on the basis of established Public

Health Service referral guidelines.  Applications will be reviewed

for scientific and technical merit by study sections of the Division

of Research Grants, NIH, in accordance with the usual NIH peer review

procedures.  Following study section scientific and technical review,

the applications will receive a second-level review by an appropriate

national advisory council.



AWARD CRITERIA



Applications will compete for available funds with all other approved

applications assigned to the NCI.  The following will be considered

in making funding decisions: (1) quality of the proposed project as

determined by peer review; (2) availability of funds; and (3) balance

among research topics within the announcement.



INQUIRIES



Written and telephone inquiries are encouraged.  The opportunity to

clarify any issues or questions from potential applicants is welcome.



Direct inquiries regarding programmatic issues to:



D. Michael Anderson, Ph.D., M.P.H.

Division of Cancer Prevention and Control

National Cancer Institute

Executive Plaza North, Room 232

Bethesda, MD  20892-4200

Telephone:  (301) 496-8584



Direct inquiries regarding fiscal matters to:



Victoria Price

Division of Grants Administration

National Cancer Institute

Executive Plaza South, Room 242

Bethesda, MD  20892-4200

Telephone:  (301) 496-7800  ext. 52



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic

Assistance No. 93.399.  Grants will be awarded under the authority of

the Public Health Service Act, Title III, Section 301 (Public Law

78-410, as amended; 42 USC 241) and administered under PHS grant

policies and Federal Regulations 42 CFR Part 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.



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