Full Text CA-93-030

NATIVE AMERICAN WOMEN'S CANCER INITIATIVE

NIH GUIDE, Volume 22, Number 22, June 18, 1993

RFA:  CA-93-030

P.T. 34, FE, II

Keywords: 
  Cancer/Carcinogenesis 
  Disease Control+ 
  Disease Prevention+ 


National Cancer Institute

Letter of Intent Receipt Date:  July 30, 1993
Application Receipt Date:  October 13, 1993

PURPOSE

The Special Populations Studies Branch (SPSB), Division of Cancer
Prevention and Control (DCPC), National Cancer Institute (NCI)
invites grant applications to conduct research to develop and
determine the effectiveness of cancer control and prevention
intervention strategies in Native American women, including American
Indian, Alaska Native, Native Hawaiian and/or American Samoan women.
The long range goals of this initiative are to improve cancer
survival rates and reduce cancer mortality rates among Native
American women through cancer prevention and control 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 Request
for Applications (RFA), Native American Women's Cancer Initiative
(NAWCI), 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 public and private, for-profit and
non-profit organizations serving the indigenous female community in a
specified geographic area such as Native American health clinics
(e.g., P.L. 93-638 clinics); voluntary Native American organizations;
Native American research centers or consortia; hospitals that serve
large numbers of Native American women; consortia of female health
providers; and/or Federal (e.g., the Indian Health Service), State or
local governments.  Teams of applicants are encouraged, but one
organization must be identified as the lead institution to assume
responsibility for the conduct of the project.

MECHANISM OF SUPPORT

The assistance mechanism used to support these studies will be the
traditional National Institutes of Health (NIH) research project
grant (R01).  The applicant has sole responsibility for planning,
direction, and execution of the proposed project.  Total project
period for applications submitted in response to this RFA may not
exceed four years.  The anticipated award date is May 1, 1994.

Awards will be administered as stated in this RFA and 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.

This RFA is a one-time solicitation.  Future unsolicited competing
continuation applications will compete as research project
applications with all other investigator initiated applications and
be reviewed according to the customary peer review procedures.  If
the NCI determines that there is sufficient continuing program need,
the NCI will invite recipients of awards under this RFA to submit
competing continuation applications for review.  The range of the
amounts of the direct cost will vary from $130,000 to $320,000 per
year.

FUNDS AVAILABLE

Approximately $1.5 million in total costs per year for four years
will be committed to specifically fund grants awarded under this RFA.
It is anticipated that up to five awards will be made, at least one
from each of the options listed under RESEARCH OBJECTIVES.  This
level of support is dependent on 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 research
grants pursuant to this RFA is contingent upon the availability of
funds for this purpose.

RESEARCH OBJECTIVES

Background

In 1987 the NCI sponsored a working group on cancer among Native
Americans.  As a result of that meeting, two RFAs were issued in 1989
(one on avoidable mortality from cancer among Native Americans and
the other on primary prevention of cancer among Native Americans).
Eight awards were made for these RFAs, four for avoidable mortality
and four for primary prevention.  The target populations for these
five year cooperative agreements were reservation and rural American
Indians, urban American Indians, Alaska Natives (urban and rural),
and Native Hawaiians.

The Native American Women's Cancer Initiative (NAWCI) evolved from
these five year cooperative agreements.  Based on the preliminary
findings, this initiative has been developed to appropriately respond
to emerging cancer needs and issues of Native American women.  At the
turn of the century, cancer was an extremely rare disorder among
American Indian people (Hrdlicka, 1904, Jones, 1989, p.45).  Although
American Indians and Alaska Natives continue to experience low cancer
incidence rates in comparison with other racial groups such as
whites, blacks, and Asians, within the last few generations cancer
has become the leading cause of death for Alaska Native women, and is
the second leading cause of death among both American Indian and
Native Hawaiian women. (Department of Health and Human Services, IHS
Trends, 1992, p. 34, IHS, Cancer Mortality, 1992.)

A report entitled, "A National Strategic Plan for Cancer Prevention
and Control to Benefit the Overall Health of American Indians and
Alaska Natives" was prepared by the NCI-supported Network for Cancer
Control Research among American Indian and Alaska Native Populations.
The purpose of this plan is to enhance the awareness in federal
agencies and in others about the problems of cancer among American
Indian and Alaska Native populations.  This plan emphasizes the poor
cervical and breast cancer survival rates, the lack of access to
early detection services, the lack of Indigenous health care
providers and researchers, and the cultural barriers that interfere
with effective cancer prevention and control programs (Network, 1992,
pp. 8-10, 24, 26-28, 30, 32 and 35).

Numerous barriers have been identified that interfere with cancer
prevention and control efforts among Indigenous women.  These
barriers include, but are not limited to, culturally inappropriate
recruitment protocols, lack of culturally appropriate cancer
prevention and control materials and programs, inaccessible science
and/or research educational and training opportunities, English as a
second language, poverty, transportation, cancer causation beliefs,
lack of Native health providers, and unavailability of health
facilities.  The types and impact of such barriers vary among Native
communities in different regions of the country.

Several of the factors that may contribute to cancer among Native
American women may differ from women of other races and differ among
Indigenous women due to genetic factors, acculturation, and
socioeconomic status.

The research studies will determine the effectiveness and efficacy of
cancer control and prevention intervention strategies that are
designed to address one of the following objectives: (1) address the
barriers to culturally appropriate quality cancer control services
including screening, appropriate follow-up, diagnostic, treatment,
and rehabilitation programs for cancers that are common and/or
disproportionately elevated within Indigenous women; (2) reduce
cancer risk behaviors in Native American women (e.g., high dietary
fat intake, tobacco use, alcohol consumption); or (3) assist in
providing technical assistance to improve Native American women's
research skills and eventually increase the number of Native American
women who are in key research positions (e.g., Principal
Investigators).  These objectives are more fully defined Research
Options and Scope, below.

1.  American Indian Women

According to the New Mexico SEER Registry (1977-83), the most
commonly occurring cancers in American Indian women are (in order of
their occurrence) breast, cervix uteri, gallbladder, and stomach
cancer.  According to the National Center for Health Statistics
(1977-83), the most common causes of cancer death among American
Indian women are (in order) lung and bronchus, breast, colon and
rectum, cervix uteri, and stomach.  Nine of the twelve IHS Areas
(1984-88) identify the five leading causes of cancer mortality among
American Indian females to be lung cancer (17%), ill-defined/unknown
(11.2%), breast (11.0%), cervix (7.4%), and colon/rectum (7.2%).
(IHS, Cancer Mortality among Native Americans in the United States,
1992 , p. 53).  The New Mexico SEER Registry (1975-84) five-year
relative survival rates among American Indian women are poorer for
all sites combined than for all other racial groups, such as whites,
blacks, and Asians.  In addition, survival rates for breast, kidney
and renal, pelvis, colon and rectum, pancreas, gallbladder, stomach,
lung and bronchus, and non-Hodgkins lymphoma are lower among American
Indian women than are survival rates for whites, blacks, Hispanics,
and Asians.

2.  Alaska Native Women

Based on the State of Alaska data (1969-83) in comparisons with U.S.
white women, Alaska Native female incidence rates are higher for oral
cavity and pharynx, nasopharynx, esophagus, stomach, colon and
rectum, liver, gallbladder, pancreas, cervix uteri, and kidney and
renal pelvis cancers.  According to the Alaska Area IHS (1984-88),
Alaska Native women have significantly higher age-adjusted mortality
rates than do U.S. All Races Females for the following cancers:  Lung
and bronchus (Alaska Native women = 68.5; U.S. All Races females =
27.3); colon-rectum (Alaska Native women = 33.0; U.S. All Races
females = 17.1); ill-defined/unspecified sites (Alaska Native women =
28.8; U.S. All Races females = 10.3); cervix uteri (Alaska Native
women = 9.3; U.S. All Races females = 3.1); stomach (Alaska Native
women = 9.3; U.S. All Races females = 3.3); and, gallbladder (Alaska
Native women = 7.6; U.S. All Races females = 1.0). (IHS, Cancer
Mortality among Native Americans in the United States, 1992 , pp.
58-61)

Five year survival data are not available for Alaska Natives.

3.  Native Hawaiian Women

Based on Hawaii SEER Registry data (1977-83), when compared with
other racial groups such as blacks or whites, Native Hawaiian women
have the highest age adjusted (1970 U.S. Standard) incidence rates
per 100,000 for breast (108.5), lung (45.8), corpus uteri (29.4),
stomach (19.5), ovary (15.1), urinary bladder (5.7), and brain and
central nervous system (3.5).  In addition, they have excessive
cancer incidence for cervix uteri (15.2) when compared with whites.
(NCI, Report of the Special Action Committee, 1992, p. A-4)

Based on Hawaii SEER Registry data (1975-84) Native Hawaiian women
have the poorest survival from cancer of oral cavity and pharynx
(36.4) than any racial group.

4.  American Samoan Women

Cancer incidence, mortality, and survival data are available for very
small numbers or groups of American Samoan women. Informal reports
from the island of American Samoa and from American Samoan women
living in the continental United States indicate that cancer is a
significant problem and appears to be increasing.  There is need for
accurate collection and recording of such data.

5.  Brief Summary of Selected Cancer Sites and Regional Data

A brief description follows of a few of the common and/or
disproportionate cancer sites in Indigenous women. Data provided
below should be viewed as examples only; other cancer sites would be
considered as well.

a.  Cervical Cancer

Incidence:  Alaska Native women have the highest cervical cancer
incidence rate of any racial group (with a rate of 28.0) (State of
Alaska, 1969-83).  According to the New Mexico SEER Registry
(1977-83), American Indian women living in New Mexico and Arizona
have a cervical cancer incidence rate of 20.5.  Native Hawaiian women
have an incidence rate of 15.2 (Hawaii SEER Registry, 1977-83).  The
white female rate is 8.6.  When existing incidence data are reviewed,
each American Indian and Alaska Native tribe or IHS Area has higher
cervical cancer incidence than SEER whites.  For example, Tohono
O'Odham/Pima Tribes (rate=41.7), Athabascan Alaska Natives
(rate=39.4), Eskimo Alaska Natives (33.1), Billings IHS Area (32.3),
Apache Tribes (31.8), Albuquerque IHS Area (31.3), Aleut Alaska
Natives (29.7), Alaska IHS Area (29.5), Sioux Tribes (29.2).
(Nutting, et al, "Cancer in American Indians and Alaska Natives,
1982-87", AJPH, 1993)

Mortality:  The Alaska Tumor Registry (1977 to 1983) reported that
Alaska Native women have the highest death rate from cervical cancer
of any race with a rate of 12.5.  According to the National Center
for Health Statistics 1977-1983, the American Indian cervical cancer
mortality rate was 5.5 and the Native Hawaiian rate was 5.6.  The
white rate was 3.2.  When IHS Area data are reviewed (1984-88), all
IHS Areas have cervical cancer mortality rates higher than the U.S.
rate and six of the nine Areas have rates significantly higher than
the U.S.  All Races rate: Billings, Aberdeen, Nashville, Albuquerque,
Alaska, and Navajo. (IHS, Cancer Mortality among Native Americans in
the United States, 1992 p. 39).

Survival:  According to the New Mexico SEER Registry (1975-84),
American Indian women have the second poorest five-year relative
survival rate from cervical cancer than all other racial groups with
a rate of 65.1.  Blacks have the poorest with a rate of 61.3.  The
Native Hawaiian female rate is 67.3 and the white rate is 67.2.
Survival data for Alaska Native women are not available.

b.  Breast Cancer

Incidence:  Native Hawaiian women have the highest age-adjusted
breast cancer incidence rates of any race with a rate of 108.5
(Hawaii SEER Registry, 1977-83).  The rate among white women is 93.3.
Based on data from American Indian women living in Arizona and New
Mexico (1977-83), the age-adjusted breast cancer incidence rates are
much lower among American Indian women (rate of 21.7) than among
white women.  Alaska Native women also have low breast cancer
incidence with a rate of 44.2.  However, regional variability among
breast cancer incidence data are apparent.  The age-adjusted
incidence of breast cancer is lower among American Indian women of
the lower 48 states, and among Aleuts and Eskimos.  However,
Athabascan Alaska Native women have a rate (106.1) comparable to the
U.S. female rate.  American Indian women who live in the northern
states have poorer rates (e.g., Sioux tribes, Aberdeen IHS, Billings
IHS).  (Nutting, et al, "Cancer in American Indians and Alaska
Natives, 1982-87", AJPH, 1993)

Mortality:  Native Hawaiian women have the highest breast cancer
mortality rates of any race (37.8) (Hawaii SEER Registry, 1977-83).
The white female rate is 26.7.  According to U.S. mortality data
(1977-83), the age-adjusted breast cancer mortality rates are lower
for American Indian females (9.0) and Alaska Native females (12.8)
than the white rate.  Unfortunately, a recent review of the limited
trend data indicate that the breast cancer mortality rates are
accelerating.  (O'Brien, AIHCA, 1991)  Examples of IHS Areas breast
cancer mortality rates that illustrate the variability of data follow
(1984-88):  Nashville IHS Area (25.5), Aberdeen IHS Area (24.0),
Bemidji IHS Area (19.0), and Albuquerque IHS Area (10.4).  (IHS,
Cancer Mortality among Native Americans in the United States, 1992)

Survival:  Although the overall breast cancer incidence and mortality
rates are lower among American Indian women, according to the New
Mexico SEER Registry (1975-84), American Indian women living in
Arizona and New Mexico have the poorest survival rate (49.7) of any
racial group.  The Native Hawaiian survival rate is 69.4 and the
female white survival rate is 75.7.  Alaska Native survival data are
not available.

c.  Gallbladder Cancer

Incidence:  Gallbladder cancer incidence rates are disproportionately
high among indigenous females.  According to the New Mexico SEER
Registry (1977-83), American Indian women living in Arizona and New
Mexico have an incidence rate of 14.7.  Alaska Native females also
have an incidence rate of 14.7 (State of Alaska, 1969-83).  These
rates are the highest of any other racial group and indicate that
gallbladder cancer is approximately nine times more likely to occur
in an American Indian or Alaska Native woman than in a white woman.
The female white gallbladder incidence rate is 1.6.  The Native
Hawaiian female gallbladder incidence rate is 1.0 (NCI, Report of the
Special Action Committee, 1992, pp. A-2, A-3, A-4).

The gallbladder incidence rates vary among American Indian women from
different tribes and among different regions.  For example,
gallbladder incidence rates from selected tribes and IHS Areas (IHS,
1982-87) include the following:  Tohono O'Odham/Pima Tribes (33.4),
Apache Tribes (20.5), Phoenix IHS Area (16.1), Alaska IHS Area
(14.4), Navajo Tribe (10.8), Eastern Band Cherokee Tribe (10.7), and
Sioux Tribes (5.9).  (Nutting, et al, "Cancer in American Indians and
Alaska Natives, 1982-87", AJPH, 1993)

Mortality:  American Indians women also have disproportionately high
gallbladder cancer mortality rates.  According to the National Center
for Health Statistics (1977-83) American Indian women have a rate of
3.6 and Alaska Native females have the highest rate of any racial
group with a rate of 6.3.  The female gallbladder mortality rate for
nine of the IHS Areas (IHS, 1984-88) is 7.6.  The IHS Tucson Area
(1984-88) had the highest age-adjusted gallbladder cancer mortality
rate for females (24.1) which is about 20 times the white female rate
of 1.2.  Native Hawaiian women have a low mortality rate of 0.3.
(NCI, Report of the Special Action Committee, 1992, , p. A-7)

Survival:  According to the New Mexico SEER Registry (1975-84),
American Indian females who live in Arizona and New Mexico also have
the poorest gallbladder survival rates of any racial group with a
rate of 6.4 (white female rate is 9.4).  There were too few cases to
accurately determine a survival rate for Native Hawaiian women.
(NCI, Report of the Special Action Committee, 1992, pp. A-8, A-9,
A-10) Survival data for Alaska Natives are not available.

d.  Lung Cancer

Incidence:  According to Hawaii SEER Registry 1977-83, Native
Hawaiian female lung and bronchus cancer incidence rate is the
highest of any racial group at 45.8 (white female rate is 33.3). The
Alaska Native female lung cancer incidence rate is 23.2 (State of
Alaska, 1969-83).  According to the New Mexico SEER Registry
(1977-83), lung cancer incidence rates of American Indian females
living in Arizona and New Mexico is the lowest of any racial group
with a rate of 4.4.  Examples of female tribal and IHS Area lung
cancer incidence rates follow (IHS, 1982-87):  Athabascan Alaska
Natives (111.3), Aleut Alaska Natives (101.7), Eskimo Alaska Natives
(53.2), Alaska IHS Area (58.4), Bemidji IHS Area (52.3), Billings IHS
Area (37.8), Aberdeen IHS Area (32.1), Eastern Band Cherokee Tribe
(35.2), and Sioux Tribes (34.1).  (Nutting, et al, "Cancer in
American Indians and Alaska Natives, 1982-87", AJPH, 1993)

Mortality:  Native Hawaiian women have the highest lung cancer
mortality rates (35.3) of any race (Hawaii SEER Registry, 1977-83).
Alaska Native women have a rate of 15.0 and white women are 20.9.
According to the National Center for Health Statistics death records,
the age-adjusted American Indian female lung cancer mortality rates
are among the lowest of any race with a rate of 9.3.  However, as
geographic areas indicate rates which are higher than those reported
in NCHS.  IHS age-adjusted lung cancer mortality rates (1984-88) for
females follow:  Alaska IHS Area (68.5), Billings IHS Area (65.7),
Aberdeen IHS Area (45.0), Bemidji IHS Area (40.7), and Nashville IHS
Area (25.1). (IHS, Cancer Mortality among Native Americans in the
United States, 1992 , p. 34)

Survival:  Survival data are not available for Alaska Natives.
American Indian women living in New Mexico and Arizona have a poorer
lung cancer survival rate (14.1) than do white women (17.1).  Native
Hawaiian women have a five-year relative survival rate of 17.0. (NCI,
Report of the Special Action Committee, 1992, p. A-10)

6.  Research Options and Scope

This RFA for the NAWCI has three options.  Option A focuses on
common/disproportionate cancer rates and barriers to early detection
services, Option B emphasizes reduction of risk factors, and Option C
stresses research capacity development among Native American women.
It is anticipated that up to five awards will be made, at least one
from each option.  The total project period of these awards may not
exceed four years.  The applicant must specify which option is the
focus in the application and it is recommended that only one option
be the focus of any application.

Option A:  Common/Disproportionate Cancer and Barriers

Cancer Intervention Research in Native American Women will focus on
cancers that are more common among Native American Women and support
the development of long-term intervention strategies.  These projects
will develop, implement and evaluate interventions that are designed
to overcome the barriers that Native American women experience in
obtaining culturally appropriate quality cancer control services
including screening, appropriate follow-up, diagnostic, treatment,
and rehabilitation programs.  The efficacy and effectiveness of these
culturally appropriate interventions will be assessed.  These
projects will focus on cancers that are more common among Native
American women from a specified area (e.g., breast cancer among
Native Hawaiian women, gallbladder cancer among Southwestern Indian
women, lung cancer among Alaska Native women), or they may address
the unusually aggressive forms of cancers in Native American women
(e.g., young Southwestern American Indian women progressing from
Class II Pap smear to invasive cervical cancer within 24 months)
(Becker, 1992).

Option B:  Risk Factors

Cancer Risk Factors among Native American Female Populations will
develop, implement and assess cancer prevention and control
interventions that are designed to reduce risk factors of this
population in regions of the country where the cancer control needs
of American Indian and Alaska Native women have been increasing and
data are sparse (e.g., Northern Plains region, Northwestern U.S.,
Northeast U.S., Southeast U.S., remote Alaska Native Villages).
Unusual behaviors, such as frequent use of smokeless tobacco, high
consumption of smoked, high fat foods; or access to high fat
commodity as a sole source of food availability, may be emphasized.

Option C:  Research Capacity Development

Research Capacity Development Workshops will be designed to provide
technical assistance to increase the research application and
scientific skills of Native American women.  The aim of these
workshops is to increase the number of Native American women who
pursue research careers and/or become co-investigators or Principal
Investigators of NCI research projects.  These grants would involve
developing and implementing workshops in different hard-to-reach
Native populations and providing them with technical assistance in
the development of research ideas and applications.  The
effectiveness of these workshops will be evaluated.  The Research
Capacity Development workshops will be limited to human research and
the clinical-behavioral fields only.

The aim of the NAWCI is to support studies in four or five different
geographic regions of the United States.  Although every attempt will
be made to provide regional representation, the possibility exists
that applications may not be awarded for all geographic regions
and/or Native American populations.

Intervention strategies may differ between Native Americans living in
urban areas, those remaining on reservations or villages, and/or
those residing on American Samoa or Hawaii.  All such groups are
eligible for study under this RFA.

The NCI considers it essential that multiple and key Native American
community organizations and groups be involved in the development and
implementation of comprehensive, community-wide programs to prevent
and control cancer within communities.  The NCI recognizes the
heterogeneity of Native American women and their unique status of
being from Sovereign Nations.

An active collaboration among investigators, the selected Indigenous
groups, and local health care providers is essential.

One of the challenges of this RFA is to collect new or obtain
existing data.  The applicant may use SEER data when appropriate and
other data sources, such as Indian Health Service or local
clinic/hospital records when available.  The applicant needs to
acknowledge the strengths and weaknesses of data appropriate for the
target populations and to determine how sufficient data are to be
collected to assist in the development, implementation and assessment
of an innovative cancer prevention and control project within a four
year period of time.

These studies will have three phases within the four years.  Phase I
- A planning phase, Phase II - an intervention and evaluation plan
implementation phase, and Phase III - data analysis, report
preparation and dissemination among both lay and professional Native
Americans and non-Natives.

Note:  Option C may not require the full 48 months.

a.  Phase I:  Planning and Organization (12 months)

Depending on which option is being addressed, the planning and
organization phase includes tasks such as the hiring of project
staff, meeting with the community advisory groups, maintaining
collaboration with the Native American populations, obtaining special
equipment that was approved in the project budget, selecting through
randomization, which study populations are to be controls and which
are to receive the intervention(s), developing or adapting data
collection instruments, development of intervention materials,
implementing qualitative assessment of developed instruments or
materials to determine cultural acceptability, implementing the
collection of baseline data, developing and revising the recruitment
plan of study participants, and developing and implementing the
training program for data collectors.

b.  Phase II:  Intervention and Evaluation Plan Implementation (30
months)

This phase is the implementation and evaluation of the proposed
intervention.  The applicant should discuss how each aspect of the
proposed intervention is to occur and when and how process evaluation
measures will be conducted.  Progress towards planning,
implementation, evaluation, and documentation will be measured.
Publications should be developed and submitted regarding significant
aspects of the project (e.g., the development of innovative
intervention materials; successful recruitment plan, baseline data).
Regular articles of information should be provided to the Native
American population for inclusion in local newspapers, radio stations
and so on to keep them apprised of research progress and their
involvement throughout the project.

c.  Phase III:  Data analysis, report preparation and dissemination
(6 months)

Analysis of outcome measures will be organized into reports that
include a discussion of findings and conclusions.  These reports must
involve the participation of the Native American population to avoid
repeated problems of Indigenous participants being excluded from this
aspect of the study.  A series of appropriate articles should be
generated and submitted to refereed publications.  A series of
articles needs to be adapted for inclusion in Native American media.

SPECIAL REQUIREMENTS

The NAWCI Program Director will review all key personnel recruitment
and changes during the project period and may approve or disapprove
any changes.  Key personnel are the Principal Investigator,
co-investigators, and others specifically identified in the Notice of
Grant Award.

1.  Participation in Meetings

The awardees will be invited to attend periodic NCI-coordinated
meetings, approximately two each year.  These meetings will serve as
a forum to exchange ideas and information on program progress.  The
Principal Investigators and other appropriate project staff will
attend these meetings.  "Appropriate" project staff will be
identified by the NAWCI Program Director and by the nature of the
agenda of each meeting.  Approximately two 2-day meetings will be
held in Washington, DC each year.  Up to three project staff may
attend, including the Principal Investigator.  Travel funds for these
meetings must be included in the applicant's proposed budget.

2.  Implementation of Common Data Collection among Grantees

Applicants will be encouraged to collaborate with other NAWCI
grantees on the development, implementation and assessment of common
data collection items and techniques tht are culturally acceptable to
the subjects.

3.  Reporting requirements

The awardees will provide brief annual reports and additional
information as requested by the NAWCI Program Director.

4.  Publications and Presentations

It is expected that data and program findings will be presented and
published through a variety of mechanisms to reach health
professionals and the Native American population.  Publication of
data findings and process activities by the awardees is encouraged.
As noted in the instructions of the PHS 398, copies of reports,
publications, and major presentations are to be provided to the NAWCI
Program Director.  The awardees will acknowledge NCI support in
publication or oral presentation of work completed under this
research grant.

5.  Data Management

Although the awardees retain custody of and primary rights to the
data developed under these awards, consistent with current HHS, PHS,
and NIH policies; the NAWCI Program Director will be provided access
to all data developed under this award.

6.  Program Materials

Program materials developed for training sessions, media campaigns,
community meetings, public education, and other purposes will be
inventoried and copies requested by the NAWCI Program Director.

7.  Process and Outcome Measures

The applicants must identify the sorts of cancer prevention and
control outcome measures they would use to evaluate the project and
describe in detail the observations and records they would use.
Methods of data accrual, coordination of data accrual, and data
analysis should be described and any contemplated studies or
publication plans.

8.  Other

The applicants should define the geographic boundaries of the
proposed project and describe in detail how they plan to involve
Native American organizations (e.g., tribal councils, Native health
planning councils/committees, Native Health Boards, 93-638 health
clinics, the Indian Health Service, Indigenous hospitals, cancer
centers, etc.).  Efforts to ensure community acceptance should be
described and where specific cultural barriers are important, the
applicants must provide a plan for addressing those barriers.
Applicants are expected to include Indigenous women as
co-investigators on the research team.

STUDY POPULATIONS

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

The targeted population intended under this RFA is the approximately
1.5 million American Indian, Alaska Native, Native Hawaiian, and
American Samoan women living in U.S. territory.  The study population
for this RFA complies with the NIH policy that women and minorities
must be included in clinical study populations.

LETTER OF INTENT

Prospective applicants are asked to submit, by July 30, 1993, a
letter of intent that includes a descriptive title of the proposed
research, the name and address of the Principal Investigator, the
names of other key personnel, the participating institutions, 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 subsequent applications, the information
it contains is helpful in planning for the review of applications.
It allows NCI staff to estimate the potential review workload and to
avoid possible conflict of interest in the review.  The letter of
intent is to be sent to Dr. Linda Burhansstipanov at the address
listed under INQUIRIES.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research and from the Office of
Grants Inquiries, Division of Research Grants, National Institutes of
Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone
301/435-0714.

The RFA label available in the PHS 398 application form 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 title and number should 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 clear and single-
sided photocopies,
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, Referral Officer
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 636
Bethesda, MD  20892

Applications must be received by October 13, 1993.  If an application
is received after that date, it will be returned to the applicant.
The Division of Research Grants (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 substantial revisions of applications already
reviewed, but such applications must include an introduction
addressing the previous critique.

REVIEW CONSIDERATIONS

Review Procedures

Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by NCI staff.  Incomplete applications will be
returned to the applicant without further consideration. If the
application is not responsive to the RFA, NCI program 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 at the next cycle.

Applications may receive a preliminary scientific peer review
(triage) by an NCI peer review group on the basis of relative
competitiveness.  The NCI will remove from further competition those
applications judged to be non-competitive for award and notify the
applicant Principal Investigator and institutional official.  Those
applications that are competitive will be evaluated in accordance
with the criteria stated below for scientific/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
(NCAB).

Generic Review Criteria (for all 3 Options)

Each research application will be reviewed on its own merit.
Applicants are encouraged to submit and describe their own ideas on
how best to meet the goals of this RFA.  Applications will be judged
on the following review criteria:

1.  Collaboration with and availability of a Native American female
population for study

a.  Applicants (whether Native or non-Native) must provide detailed
evidence of their ability to obtain cooperation and information from
the selected Native groups, and verify the involvement of indigenous
peoples in key research roles (e.g., co-investigators) on the
project.  Substantiating data to verify Native participation should
be included, such as a letter of agreement or a tribal resolution
from the target Native American population indicating agreement to
participate and collaborate in the study.  Applicants should
incorporate plans for including indigenous researchers in the
subsequent publications related to this study.

b.  The application must be consistent with the goals and objectives
of the RFA, and include feasible and appropriate time line,
resources, proposed budget to accomplish the objective(s) of this RFA
in a culturally acceptable manner.

2. Evidence of ability to establish collaboration with Indigenous
groups and other agencies involved in health care of the selected
populations.

3.  Originality and scientific merit of the application submitted,
the discussion of considerations relevant to this RFA.

a.  Capability to perform the work proposed.

b.  The research plan, design, and evaluation should be culturally
sensitive and acceptable to Native American women.

c.  Documentation of cancer needs of the target population.

d.  The evaluation (process and outcome) methods should be identified
within the timeline.

e.  Outcome evaluation should be based on clear and measurable
indicators of progress toward project goals and designed to result in
valid conclusions concerning the effectiveness of the project.

f.  The application should include a plan to disseminate results,
findings, outcome measures to both Native and non-native
professionals and to members of the target populations' community.

4.  Experience of the applicants.

a.  The Principal Investigator, co-investigators and other key
personnel should have appropriate qualifications, experience and
commitment for their respective roles on the project.

b.  Key personnel should be able to devote adequate time for the
effective conduct of the study.

c.  Qualified indigenous people should be in key research roles and
involved in each phase of research.

d.  The research team should include key personnel who have
experience working with Native Americans and demonstrated evidence of
cultural acceptability by Indigenous women.

5.  Demonstrated willingness to work together with other project
staff and NCI staff as well as a willingness to collaborate with
other applicants on common research tasks if feasible.

6.  Appropriateness of the proposed budget and duration in relation
to this proposal initiatives.

a.  The application should include a budget which is reasonable for
the tasks specified in the research plan and includes budgetary
justification.

b.  A description of facilities and resources available and/or needed
should be included in the application.

c.  Travel funds for the Principal Investigator to attend semi-annual
meetings in Washington, DC must be included in the applicant's
proposed budget.

Review Criteria for Option A:  Common/Disproportionate Cancer and
Barriers

In addition to the generic review criteria, applications that focus
on Option A will be judged on the following criteria:

a.  Demonstrated ability to recruit sufficient numbers of Native
American women for the intervention and evaluation phase.

b.  Documentation of (1) cancers that are disproportionate to the
selected group of Native American women; and/or, (2) barriers to
obtaining state-of-the-art prevention and/or early detection
technology.

c.  Cancer incidence, mortality, and survival rates for the selected
group of Native American women.  NCI recognizes that there is a
dearth of cancer data for Native American women.  When no quality
data are available that can appropriately describe the selected
Native American female population, the applicant needs to explain how
such data will be collected to assist in the development of the
proposed intervention.  Whenever possible, the applicant must cite
the best available data (e.g., Onondaga tribe may cite Seneca or
Mohawk data and New York State data, and then explain in what ways
those data are appropriate to the Onondaga Peoples or why those data
are not generalizable to their tribe).

d.  Demonstrated originality of the research design; illustrated
appropriateness of control population; and, inclusion of
interventions which are culturally acceptable and sensitive to Native
American women and are likely to overcome barriers to early detection
technology.

e.  Evidence of qualifications, training, and competency of key
personnel who have experience in the conduct of cancer prevention and
control intervention studies.

f.  Evaluation plans should be appropriate for the interventions,
feasible, comprehensive and culturally acceptable to Native American
populations.

Review Criteria for Option B:  Risk Factors

In addition to the generic review criteria, applications that focus
on Option B will be judged on the following criteria:

a.  Demonstrated ability to recruit study populations of sufficient
size to generate conclusions and generalizations to other similar
groups when feasible (e.g., include power statistic calculations when
feasible).

b.  Documentation of cancer-related risk factors that are prevalent
for the selected group of Native American women should be explained.

c.  Demonstrated originality of the research design, illustrated
appropriateness of control population, and inclusion of risk
reduction or health promotion interventions that are culturally
acceptable and sensitive to Native American women and are likely to
reduce cancer risk behaviors.

d.  Evidence of qualifications, training, and competency of key
personnel who have experience in the conduct of cancer prevention and
control intervention studies.

e.  Documentation of the appropriateness of the evaluation plans for
the interventions, feasible, comprehensive and culturally acceptable
to Native American populations.

Review Criteria for Option C:  Research Capacity Development

In addition to the generic review criteria, applications that focus
on Option C will be judged on the following criteria:

a.  Clarification and inclusion of the Research Capacity Development
workshops' content, schedule, logistics, organization, and
implementation plan(s).

b.  Specification of participant selection criteria.

c.  Demonstrated ability to recruit interested educated indigenous
women as workshop participants; justification of the number of
participants to be recruited to each workshop.

d.  Documentation of the Research Capacity Development Workshops'
evaluation plan; inclusion of a description of how the workshops are
evaluated and how the participants' increased research skills are to
be assessed.

e.  Clarification regarding the types of materials and resources that
are to be provided to the participants.

f.  Clarification of the types of technical assistance that are to be
provided to the participants.

g.  Evidence of qualifications, training, and competency of the
workshops' faculty; the inclusion of qualified indigenous people
and/or people who have conducted Native American research.

AWARD CRITERIA

The anticipated date of award is May 1, 1994. NAWCI studies are
envisioned as taking place in four or five different geographic
regions of the United States.  Geographic regions may or may not be
represented by groups from Alaska, Hawaii, and/or American Samoa.
Whether Alaska, Hawaii, and/or American Samoa are or are not
represented every attempt will be made to provide regional
representation with the other states.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.  Direct inquiries regarding programmatic
issues and address the letter of intent to:

Linda Burhansstipanov, Dr.P.H.
Division of Cancer Prevention and Control
National Cancer Institute
Executive Plaza North, Room 240
Bethesda, MD  20892
Telephone:  (301) 496-8589

Direct inquiries regarding fiscal issues to:

Eileen Natoli
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD  20892
Telephone:  (301) 496-7800 Ext. 56

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.399 Cancer Control.  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 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.

REFERENCES

Becker, T.M., C.M. Wheeler, N.S. McGough, S.W. Jordan, M. Dorin, J.
Miller, Cervical Papillomavirus Infection and Cervical Dysplasia in
Hispanic, Native American, and non-Hispanic White Women in New
Mexico, Epidemiology 1991.

DHHS, PHS, IHS, Cancer Mortality among Native Americans in the United
States: Regional Differences in Indian Health, 1984-1988; Trends Over
Time, 1968-1987. Washington, D.C. 1992. [DHHS Publication number
pending; to obtain copy of publication, contact Roberta Paisano,
505/766-5557]

DHHS, PHS, IHS, Indian Women's Health Care Consensus Statement: IHS
Round Table Meeting January 1991. Rockville, MD 1991.

DHHS, PHS, NIH, NCI, DCPC, Report of the Special Action Committee
1992: Program Initiatives Related to Minorities, the Underserved, and
Persons Aged 65 and Over. Bethesda, MD, 1992. [to obtain a copy of
publication, contact Judith Swan, 301/496-1071]

DHHS, PHS, IHS, Trends in Indian Health. Rockville, MD, 1992.

Network for Cancer Control Research among American Indian and Alaska
Native Populations, A National Strategic Plan for Cancer Prevention
and Control to Benefit the Overall Health of American Indians and
Alaska Natives, October 1992. [to obtain a copy, contact
Burhansstipanov at 301/496-8589]

Nutting, P. A. and W. L. Freeman, S. G. Helgerson, D. R. Risser,
Cancer in American Indians and Alaska Natives. American Journal of
Public Health. (paper accepted for publication) [to obtain copy of
the article, contact Wm. Freeman, 602/295-2500]

O'Brien, M., J. Vanek, and L. Welper, Urban Indian Health Comparative
Analysis Report. American Indian Health Care Association, 1991.

.

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