Full Text CA-93-15

RESEARCH IN PUBLIC AND PROFESSIONAL EDUCATION FOR THE PREVENTION AND
CONTROL OF SKIN CANCER

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

RFA:  CA-93-15

P.T. 34

Keywords: 
  Health and Safety Education 
  Cancer/Carcinogenesis 
  Skin Diseases 


National Cancer Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases

Letter of Intent Receipt Date:  March 15, 1993
Application Receipt Date:  May 20, 1993

PURPOSE

The National Cancer Institute (NCI) and the National Institute of
Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invite
applications for grants to conduct research on educational strategies
for the prevention of melanoma and non-melanoma skin cancers through
controlled studies in defined populations.  These behavioral studies
should be aimed toward reduction of high levels of exposure to
natural or artificial ultraviolet light.

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), Research in Public and Professional Education
for the Prevention and Control of Skin Cancer, is related to the
priority area of skin cancer risk reduction.  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 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign non-profit and
for-profit organizations and by public and private entities such as
universities, colleges, hospitals, laboratories, units of state and
local governments, and eligible agencies of the Federal government.
Foreign institutions are not eligible for First Independent Research
Support and Transition (FIRST) (R29) awards.  Applications from
minority and women investigators are encouraged.  Investigators
should be capable of assembling a multidisciplinary team including
health education specialists responsible for public education
interventions, trained medical personnel knowledgeable in skin cancer
for professional education interventions, and associated
statisticians, research designers, communication specialists, etc.,
for the successful implementation and reporting of a full-scale
research project.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) research
project grant (R01), and the First Independent Research Support and
Transition (FIRST) award (R29).  It is anticipated that the average
direct costs for each award will be $183,000 per year.  This is a
one-time solicitation.  Future unsolicited competing continuation
applications will compete with investigator-initiated applications
and will be reviewed according to customary NIH peer review
procedures.  Responsibility for the planning, direction, and
execution of the proposed project will be that of the applicant.

FUNDS AVAILABLE

It is anticipated that three NCI sponsored awards and one or two
NIAMS sponsored awards will be made under this RFA, and that the
total expenditures for these grants will not exceed $1,500,000 (total
costs) for the first year.  This level of support is dependent on the
receipt of a sufficient number of applications of high scientific
merit.  Although this RFA is provided for in the financial plans of
the NCI and the NIAMS, awards are contingent on the availability of
funds.  The project period for studies funded through this RFA may
not exceed four years.  The anticipated award date is April 1, 1994.

RESEARCH OBJECTIVES

Skin cancer is the fastest rising and most common form of cancer in
the United States, accounting for well over 600,000 new cases
reported every year, or about one-third of all cancer incidence.  Of
these cases, about 75 percent are basal cell and 20 percent are
squamous cell carcinomas, both of which are highly treatable and
rarely metastasize.  The remaining 5 percent of skin cancer cases are
malignant melanomas, which are far more lethal and currently account
for an estimated 32,000 new cases, and more than 6,700 deaths per
year.  Between 1973 and 1989, the incidence rate for melanoma
increased by 80.6 percent, more than any other cancer site, and far
greater than the 16.1 percent increase for all sites combined.  The
mortality rate during the same period for all races and both sexes
was 32.1 percent for melanoma, compared to the 6.1 percent cancer
mortality rate for all sites combined.  Theoretically, however, most
skin cancer morbidity, and almost all skin cancer mortality should be
preventable.

Solar radiation appears to be the primary risk factor for more than
90 percent of nonmelanoma skin cancer cases, and it has also been
linked to melanoma.  Evidence for the effect of ultraviolet (UV)
light exposure, especially the shorter wavelength UV-B rays, on skin
cancer shows that a 1 percent relative increase in UV-B radiation may
result in a 2 percent increase in skin cancer incidence.  UV-B is the
radiation that produces tanning and burning in human skin.  Concern
about the harmful effects of longer wavelength UV-A rays, which are
more common in sunlight though less mutagenic than UV-B rays, is
growing among researchers.  Overall, data appear to indicate that
nonmelanoma skin cancer is related to annual cumulative exposure, and
that melanoma may be related to high intensity, intermittent UV
radiation exposure (i.e., sunburns) particularly at a young age.

Incidence of skin cancer is also influenced by degree of skin
pigmentation and sex.  Rates are highest for Whites, lower for
Asians, and lowest for Blacks.  Skin cancer incidence is also highly
influenced by intensity of sunlight as a function of proximity to the
equator or high altitude.

It is hypothesized that there may be a growing risk of increased
exposure to UV radiation due to depletion of the Earth's atmospheric
ozone.  The effects of a significant loss of the ozone layer on human
health are not precisely known, but scientists speculate that skin
cancer rates could increase as a result.

In addition to health risks, the yearly estimated costs of treatment
for skin cancer are substantial: approximately $37.6 million for
basal cell, $28.2 million for squamous cell, and $99.7 million for
malignant melanoma, totalling $165.5 million per year.

Despite the hazards of sunlight exposure, National Health and
Nutrition Examination Survey self-report data show that a large
proportion of the U.S. population engages in moderate to high
sunlight exposure: 61.6 percent of white males, 51.2 percent of white
females, 49.8 percent of black males, and 41.6 percent of black
females.  Accordingly, the need for committed national efforts to
reduce exposure to sunlight for the purpose of preventing skin cancer
is great, and significant progress is clearly necessary.  This is
reflected in the U.S. Department of Health and Human Services' goal
for the year 2000: "Increase to at least 60 percent the proportion of
people of all ages who limit sun exposure, use sunscreens and
protective clothing when exposed to sunlight, and avoid artificial
sources of ultraviolet light (e.g., sun lamps, tanning booths)".

Thus, based on current knowledge of the risks for skin cancer, the
most prudent step, especially for those with light complexions,
males, and children, is to limit or protect against UV radiation
exposure.  Parents and caregivers should see that children receive
limited sun exposure.  For adults, decreased exposure to sunlight and
artificial sources of UV light, and use of protective clothing or
sunscreen products shown to be capable of reducing UV rays is
advisable.  Special care should also be taken by people in lower
latitudes and higher altitudes, and by everyone during the
summertime, and during the midday.

In addition to primary prevention, screening examinations could
reduce the discomfort and cosmetic problems associated with
nonmelanoma skin cancer.  And most skin cancer deaths could be
prevented through early detection of malignant melanoma, where
five-year survival rates for localized melanomas may be greater than
90 percent.  The appeal of skin cancer screening is great, not only
because of this high survival rate, but also because it is
noninvasive, quick, regarded as diagnostically reliable, and when
part of regular medical practice, has little or no cost.  Skin cancer
is also probably the foremost cancer that most people can be taught
to self-screen for with a moderate degree of reliability.  Over 90
percent of melanomas can be recognized by unaided visual examination.

This RFA has two major research objectives related to skin cancer
prevention:  (1) to study the effects of public education
interventions aimed at increasing use of sunscreens and protective
clothing, limiting exposure to solar radiation, avoiding artificial
methods of tanning, teaching skin self-examination, and improving
other behaviors related to skin cancer risk reduction; and (2) to
study the effects of professional education interventions aimed at
increasing caregivers' awareness of skin cancer, their ability to
provide advice, and their knowledge on the importance of screening
and early detection for the prevention and control of skin cancers.

Most research will take place through a facility capable of
community-based cancer prevention research, and will consist of
intervening and measuring change in a sample drawn from a population
shown to be at-risk by the investigator.  This includes pilot testing
survey instruments and techniques for feasibility and acceptability,
validating instruments, and assessing participation and adherence
rates.  Investigators may develop their own, or select from or adapt
existing materials or strategies that have been shown to be effective
in reducing exposure to ultraviolet radiation, and informing health
professionals about the risks associated with skin cancer and the use
of screening and early detection.  Techniques for validating
effectiveness of methods and materials will be the responsibility of
investigators.  To ensure results that are representative,
investigators should randomize subjects into intervention and control
groups.  These groups should be matched on risk factors such as skin
pigmentation, age, sex, ethnicity, type of UV radiation exposure
(solar, artificial, high altitude, etc.), and current or past
exposure habits.  Experimental groups must also be of sufficient size
to provide the statistical power to detect significant differences
between groups on variables of interest.

Evaluations should be designed to test questions such as:  (1) what
are the most effective educational conditions that lead to a
quantifiable reduction in skin cancer risk behaviors in specific
populations?; and (2) what are the most effective educational
conditions for increasing professional knowledge on primary
prevention, screening, and early detection of skin cancer?

The use of intermediary organizations and the formation of
public/private partnerships is strongly encouraged.  Investigators
should strive to bring together diverse groups such as producers of
sunscreen products, voluntary organizations, and organizations such
as swimming pools, or golf, yacht, or tennis clubs.

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 will
be required to include minorities and women in study populations so
that research findings can be of benefit to all people at risk of the
disease, disorder, or condition under study.  Special emphasis should
be placed on the need for inclusion of minorities in studies of
diseases 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.  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 must 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 to enable results of the study to be applied
broadly.

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,
the application will be returned.

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.

LETTER OF INTENT

Prospective applicants are requested to submit, by March 15, 1993, 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 this RFA.

Although a letter of intent is not required, is not binding, and does
not enter into the review of the subsequent application, the
information that it contains is helpful in planning for the review of
applications.  It allows NIH staff to estimate the potential review
workload, and helps to avoid conflict of interest among reviewers.

The letter of intent is to be sent to:

D. Michael Anderson, Ph.D., M.P.H.
Director, Skin Cancer Prevention Research
National Cancer Institute
Executive Plaza North, Room 218
Bethesda, MD  20892
Telephone:  (301) 496-8577
FAX:  (301) 496-8675

or

Alan N. Moshell, M.D.
Skin Disease Program Director
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 405
Bethesda, MD  20892
Telephone:  (301) 402-3342
FAX:  (301) 480-7881

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for this RFA.  These forms are available at most
institutional offices of sponsored research and may be obtained from
the Office of Grant Inquires, Division of Research Grants, National
Institutes of Health, Westwood Building, Room 449, Bethesda, MD
20892, telephone 301/496-7441.

The RFA label available in the PHS 398 application kit must be
affixed to the bottom of the face page of the application. Omission
of this label could result in delayed processing of the application
and its failure to reach the review committee in time for review.  In
addition, the number and title of this RFA must be typed on line 2a
on the face page of the application, and the YES box must be marked.

A signed, typewritten original of the application, including the
Checklist, and three signed copies must be sent or delivered in one
package to:

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 also 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 May 20, 1993.  An application
received after that will be returned to the applicant.  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 by NCI staff for
completeness and responsiveness.  Incomplete applications will be
returned to the sender without further consideration.  If the
application is not responsive to the RFA, NCI staff will contact the
applicant to determine whether to return the application to the
applicant or submit it for review in competition with unsolicited
applications in the next review cycle.

Applications may undergo triage by an NCI peer review group on the
basis of relative competitiveness.  The NCI will withdraw from
further competition those applications judged to be non- competitive
for award and notify the application's Principal Investigator and
institutional official.  Those applications that are judged to be
complete and responsive will be evaluated in accordance with the
criteria stated below for scientific or technical merit by an
appropriate peer review group convened by the NCI.  The second level
of review will be provided by the National Cancer Advisory Board or
the National Arthritis and Musculoskeletal and Skin Disease Advisory
Council.

Review criteria include, but are not limited to:

o  scientific significance and originality of proposed research;

o  appropriateness and adequacy of the experimental design and
methodology proposed to carry out the research;

o  qualifications and research experience of the Principal
Investigator and staff, particularly in the area of the proposed
research;

o  availability of resources necessary to carry out the research;

o  availability of, and capacity to recruit, adequate numbers of
subjects for statistically significant research outcomes.

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

AWARD CRITERIA

The anticipated date of award is April 1, 1994.

Applications considered responsive will be reviewed by an Initial
Review Group (IRG).  IRGs are allowed two types of recommendations;
they may give an application a priority score, or they may suggest
that an application be "not recommended for further consideration"
(NRFC).  Availability of funds, geographic distribution of awards,
characteristics of study populations, and other programmatic
priorities are also important criteria in making grant awards.

INQUIRIES

Written and telephone inquiries concerning the objectives and scope
of this RFA, whether or not specific proposed research is responsive,
the scientific content and objectives of an application, the size and
focus of a research program, and the organization of an application,
are strongly encouraged and may be directed to:

D. Michael Anderson, Ph.D., M.P.H.
Director, Skin Cancer Prevention Research
National Cancer Institute
Executive Plaza North, Room 218
Bethesda, MD  20892
Telephone:  (301) 496-8577

or

Alan N. Moshell, M.D.
Skin Disease Program Director
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 405
Bethesda, MD  20892
Telephone:  (301) 402-3342

Requests for information on fiscal policies may be directed to:

Eileen Natoli
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 242
Bethesda, MD  20892
Telephone:  (301) 496-7800, ext. 56

or

Diane Watson
Extramural Research Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 720
Bethesda, MD  20892
Telephone:  (301) 402-3352

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 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 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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