Subject: RFA CA 9l-05 2/l/9l NIH Guide
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Wed, 06 Feb 91 08:11 EST

Hi Paul,
     # 6 in the revised string.  Please post as: RFACA-91-05.910201
  Thanks.  dottie
 ---------------------------- Text of forwarded message -----------------------
 
INTERVENTIONS TO PROMOTE APPLICATION OF STATE-OF-THE-ART CANCER
MANAGEMENT IN RURAL AREAS
 
RFA AVAILABLE:  CA-91-05
 
P.T. 34; K.W. 0715035, 0403004
 
National Cancer Institute
 
Letter of Intent Receipt Date:  March 20, 1991
Application Receipt Date:  May 20, 1991
 
INTRODUCTION
 
The National Cancer Institute (NCI) invites applications for
research projects aimed at strengthening the application of
state-of-the-art cancer diagnosis and management practices in
rural areas by enhancing links between rural health care
providers and regional cancer specialists.  The researchers are
to test methods that enhance the utilization of existing cancer
expertise and resources by rural providers.  The development and
evaluation of interventions that are sensitive to the cancer
problems in a selected rural area and are supported by rural
practitioners are important.  Researchers are encouraged to be
innovative in the development of interventions.  Outcomes should
be designed to capture changes in cancer diagnosis and
management.
 
BACKGROUND AND PURPOSE
 
To date, the treatment programs of the NCI have been designed to
conduct state-of-the-art cancer treatment research through a
network of cancer specialists in university centers and community
programs.  With this initiative, the NCI strives to reach
practitioners who provide care in rural communities and link them
with cancer specialists.  Such ties are critical to assuring that
patients in rural and remote areas have access to the full range
of state-of-the-art cancer care.
 
Tremendous obstacles exist in the delivery of cancer care to
rural populations.  Access to even basic health care is complex.
Community resources for delivering comprehensive care are
diminishing, resulting in hospitals without medical specialty
resources and technical equipment, fewer physicians per capita
than in urban areas, and poorly developed transportation systems.
Even such limited resources are becoming more scarce as small
rural hospitals close due to lack of funds.  The lack of public
transportation, the need to travel long distances to obtain
health care, and limited or nonexistent health insurance or
medical benefits combine to form a major barrier to obtaining
optimal health care.
 
The rural population has a higher portion of elderly than in
urban areas, a tendency to seek medical care only for burdensome
symptoms, and few economic resources to devote to health care
plus less insurance or other third-party coverage.  In some
areas, population characteristics include additional features,
such as a large proportion of migratory farm workers.
 
Many rural health practitioners are generalists, caring for
individuals with a wide variety of diseases.  The pressures to
keep current in cancer care across many tumor types compete with
similar demands in other diseases.  Thus, it is unrealistic to
expect these clinicians to keep up to date with state-of-the-art
cancer care.  In addition, the threat that the oncology
specialist will not return patients to the rural physician for
follow-up management is real and acts as a deterrent for
referrals.  Even when cancer care is provided by a specialist,
continuing care of the patient often must occur in the rural
community where the general health provider is the only resource.
 
Major reductions in cancer mortality are believed to be dependent
upon widespread dissemination of state-of-the-art management.
Widespread dissemination must include practitioners in rural
areas.  There now exists a network of cancer care medical and
nursing specialists located in community settings as well as
university cancer centers.  These individuals and their programs
are a resource for state-of-the-art cancer management that needs
to be linked effectively with practitioners in rural areas.  The
purpose of this initiative is to develop interventions aimed at
building durable relationships between such specialists and rural
health care providers.
 
RESEARCH GOALS AND SCOPE
 
The purpose of the project is to test ways of enhancing links
between rural health care providers and cancer specialists.  The
NCI expects the interventions to be designed to strengthen
associations between the rural generalist providers and regional
cancer specialists and may include targeted training, visiting
specialists, and/or clinical trials participation.  Evaluation
should address indicators of changes in cancer diagnosis and
management practices and efficiency of the intervention.
 
1 Dependent Variables
 
Rural in this concept refers to geographical areas characterized
by low population density that are remote from sophisticated
specialty health care providers.  All rural areas are not alike.
Examples of rural areas can be found in Appalachia, Montana,
Iowa, and the northern portions of Minnesota and Wyoming.  Rural
areas are distinguished from medically underserved populations in
urban or high population density areas, which are excluded from
this initiative.
 
State-of-the-art cancer management refers to the diagnosis,
treatment, and continuing care of the cancer patient.  Diagnosis
needs to be timely in the course of the patient's symptomatic
disease, rely on the selection of appropriate diagnostic studies,
and encompass an accurate interpretation of results.  Treatment
must use currently accepted standard treatments, which are
available through such resources as Physicians Data Query (PDQ).
While treatment may include participation in clinical trials,
this is not required.  Treatment administration includes the safe
administration of chemotherapy and other medications.  The
continuing care of the patient is an integral part of
state-of-the-art care and includes prevention and/or management
of cancer-related symptoms and treatment toxicities.  For the
purposes of this research, screening of healthy populations and
palliative or hospice type care are excluded.  At a minimum, both
medical and nursing practitioners are involved in
state-of-the-art cancer management.
 
Characteristics of the Rural Environment.  The researchers are to
identify a target rural area and describe the potential
population.  Rationale for the selection of the area should
include unfavorable cancer trends, such as:
 
o late stage at cancer diagnosis, especially among tumor types
with great potential for a successful treatment when diagnosed at
an early stage;
 
o escalating mortality rates from one or more cancers that
exceeds the national trends; or
 
o predominance of a minority or special population (e.g., elderly
or pediatric patients) that is experiencing mortality from one or
more cancers at rates greater than national trends.
 
Recognizing that there are numerous approaches to health care
delivery in rural areas, it is important that the researchers
define the health care system as it exists in a specific rural
area.  In particular, the contributions to cancer diagnosis and
management of the following elements should be described:  the
informal health care system (e.g., voluntary organizations,
churches); the connections between primary care providers, local
and state health departments and local hospitals; and the
financial relationships between formal health care providers and
third-party payers (such as pre-paid health plans) and distant
medical organizations (e.g., ownership by distant hospital
corporations).  If a state cancer plan exists, existing and
planned programs that may influence cancer care should be
described.
 
Characteristics of Rural Providers.  In many localities, the
professionals, physicians and nurses will most likely be
generalists.  Their educational background, certification (if
applicable), and a description of their typical case-load should
be provided.  The rural providers must agree to participate in
the proposed intervention in making patient care decisions, and
to evaluate the effect on practice patterns of having such
resources readily available.
 
Characteristics of Cancer Specialists.  While rural community
practitioners are generalists, larger communities and urban areas
have cancer specialists who may treat rural residents or be
consultants on their care.  Researchers should describe:  (a) the
qualifications of the physician specialists and, where available,
additional specialists such as oncology nurses; and (b) location
of the specialists and whether or not any consultation or
practice time is spent in the designated rural area.
 
Existing Links Between Rural Practitioners and Cancer
Specialists.  It is anticipated that previous experience with
management of cancer patients has resulted in, at a minimum,
informal relationships or referral patterns between the rural
practitioners and cancer specialists.  Formal relationships, such
as hospital affiliations, may exist that tie the rural
generalists to some or all of the nearby cancer specialists.
 
2 Independent Variable
 
The key element of the intervention is the development of methods
to strengthen the connection between cancer specialists located
in community centers of cancer care or university-based cancer
centers and rural health care professionals.  The purpose of the
intervention is to promote the use of state-of-the-art cancer
management practices in the rural area and to allow patients to
remain in their own communities, whenever possible.
 
Based on the characteristics of the health care providers and the
patients in the rural area in which the research is to be
conducted, the researchers are to test approaches to link rural
providers and cancer specialists to enhance state-of-the-art
cancer management practices of physicians and nurses in the
selected rural area.  The interventions should incorporate, as
appropriate, established resources of the NCI, specifically the
Cancer Information Service (CIS) or the PDQ or Cancer FAX.
Examples of possible interventions include:
 
o review of screening and/or biopsy specimens;
 
o computer-assisted diagnosis and/or management algorithms;
 
o free telephone consultation between cancer specialist and
generalist provider;
 
o PDQ protocols for patient management with specialist
consultation available; and
 
o telephone hot-line service for consultation.
 
The research design should consider both process and health
outcome measures, as appropriate.  The researchers are to focus
the intervention on aspects of current cancer patient management
that are well described in the baseline data.  For example, a
pattern of head and neck cancer diagnosis at stages III and IV or
the lack of appropriate adjuvant chemotherapy for breast cancer
could be the focus.
 
Researchers should design the studies so that they can
differentiate outcomes related to the intervention(s) from
outcomes of standard, customary practices.  Methodological
issues, such as the controls learning from the intervention
group, must be considered in the design, sample size, and
analysis.  Multi-institutional participation is encouraged to
assure adequate numbers of participants in the target population
and cancer patients receiving care.  The potential for
generalization of the intervention to other rural areas must be
addressed.
 
3 Outcomes
 
While mortality rate changes may be sought, NCI realizes that the
research design may not have the power to discern such changes.
An outcome of interest is the stage of cancer at diagnosis and
the proportion of patients who receive state-of-the-art cancer
management in the target rural area.  Changes in practice are
extremely important to document, as well as evaluation of the
implementation techniques.  Numerous direct and indirect
indicators are possible.
 
Indirect indicators are acceptable if they can be measured
objectively, such as the complexity of the inquiries made by the
generalist practitioners to the cancer specialists, the use of
relevant cancer diagnostic procedures, or the intensity and
duration of side effects associated with treatment.  In
conducting the analysis, researchers should consider features of
the setting that may be either facilitators or barriers to the
actual implementation of the intervention.  Through evaluating
results of the interventions, the investigators are to determine
if any features of the intervention were more effective than
others.  In addition, recommendations should be made concerning
the potential for generalization of the intervention to other
rural settings.
 
While researchers should obtain as much baseline data as possible
in the process of the preparation of the grant application,
refinement and development of key elements can occur at the
beginning of the project period.  Researchers must justify what
information is necessary and how it will be obtained and
integrated into the refinement and finalization of the
intervention.
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF
NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN
CLINICAL RESEARCH STUDY POPULATIONS
 
NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical
research grants and cooperative agreements will be 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 need for inclusion of minorities and
women in studies of diseases, disorders and conditions which
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
compelling rationale should be provided.
 
The composition of the proposed study population must be
described in terms of gender and racial/ethnic group, together
with a rationale for its choice.  In addition, gender and
racial/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 in the form
PHS 398 in Section 2, A-D of the Research Plan AND summarized in
Section 2, E, Human Subjects.
 
Applicants/offerors are urged to assess carefully 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/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 of 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, the applicant 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 address specifically 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 the 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 or cooperative agreements that do not comply
with these policies.
 
MECHANISM OF SUPPORT
 
Support of this program will be through the National Institutes
of Health (NIH) grant-in-aid (RO1).  Applicants will be
responsible for the planning, direction, and execution of the
proposed project.  Except as otherwise stated in this Request for
Applications (RFA), awards will be administered 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.  Generally, future
unsolicited competitive continuation applications will compete
with all investigator-initiated applications and be reviewed by
the Division of Research Grants (DRG).  However, should the NCI
determine that there is a sufficient continuing program need, a
request for competitive continuation applications will be
announced.  Only recipients of awards under this RFA will be
eligible to apply.
 
Approximately $2,000,000 in total costs per year for 5 years will
be committed to specifically fund applications that are submitted
in response to this RFA.  It is anticipated that 6 to 10 awards
will be made.  This funding level is dependent on the receipt of
a sufficient number of applications of high scientific merit.
The total project period for applications submitted in response
to the present RFA should not exceed 5 years.  The earliest
feasible start date for the initial awards will be February 1,
1992.  Although this program is provided for in the financial
plans of the NCI, the award of grants pursuant to this RFA is
also contingent upon the availability of funds for this purpose.
NCI staff will take into account demographic and geographic
distribution of peer-reviewed and approved applications in the
final selection process.  Multiple applications approved for
funding and competing for the same patient population will be
considered, but may not be awarded.
 
ELIGIBILITY REQUIREMENTS
 
In order to conduct this research, it is anticipated that a
multidisciplinary, collaborative effort is necessary.
Individuals with expertise in the following should be included:
 
o cancer medicine
 
o cancer nursing
 
o general health care practitioners in rural areas
 
o health services research and evaluation research, preferably in
the areas of health care organizations, quality of care, and
information transfer.
 
Both non-profit and for-profit organizations and institutions,
and governments and their agencies are eligible to apply.
 
REVIEW PROCEDURE
 
Upon receipt, applications will be reviewed initially by the
Division of Research Grants (DRG) for completeness.  Incomplete
applications will be returned to the applicant without further
consideration.  Evaluation for responsiveness to the RFA is an
NCI program staff function.  Applications will be judged to
determine how well they meet the goals and objectives of the
program as described in the RFA.  Applications judged
non-responsive will be returned by the NCI, but may be submitted
as investigator-initiated research grants at the next receipt
date.  Questions concerning the relevance of proposed research to
the RFA should be directed to program staff as described in the
INQUIRIES section below.
 
In cases where the number of applications is large compared to
the number of awards to be made, the NCI may conduct a
preliminary scientific peer review to eliminate those
applications that are clearly not competitive.  The NCI will
remove from competition those applications judged to be
noncompetitive for award and notify the applicant and
institutional business official.
 
Those applications judged to be both competitive and responsive
will be further evaluated according to the review criteria stated
below for scientific and technical merit by an appropriate peer
review group convened by the Division of Extramural Activities,
NCI.  The second level of review by the National Cancer Advisory
Board considers the special needs of the Institute and the
priorities of the National Cancer Program.
 
REVIEW CRITERIA
 
The peer review group recommendations will be based on the
following criteria:
 
1 Relevance and significance of the research to the overall
objectives of the RFA, especially the utilization of existing
cancer resources by rural health care providers.
 
2 Scientific and technical merit and originality of the proposed
research approach, design, and methodology.
 
o Adequacy of design to deal with major methodological problems,
e.g., attrition, missing data, and ability to differentiate
setting effects from the intervention results.
 
o Adequacy of detail in description of methods or procedures.
Adequacy of data acquisition and quality control measures.
 
o Relevance and appropriateness of the study participants along
with assurance of their accessibility.  Feasibility of
implementing the proposed intervention in multiple settings.
 
o Appropriateness of sample definition, sampling plan, and sample
size.  Power analysis to support sample size selected.  Extent to
which sample is characteristic of other rural health providers
and their patients.
 
o Adequacy of instrumentation, including validity and reliability
information when available.  Special emphasis will be placed on
the capability of instruments to evaluate the adequacy of the
exchanges between rural practitioner and cancer specialist.
 
o Adequacy of the analysis plan.  Emphasis is placed on the
ability to distinguish factors that promote or impede the
intervention's full implementation.
 
3 Research experience and/or competence of the Principal
Investigator and proposed research team to conduct the proposed
studies.
 
4 Overall balance of the team in relation to the objectives of
the research project.  Availability and commitment of
multidisciplinary expertise as appropriate from the fields of
medicine, nursing, biostatistics, health services research,
public health, and others for the proposed study.
 
5 Adequacy of time (effort) that the Principal Investigator and
other investigator(s), if any, would devote to the proposed
studies.
 
6 Adequacy of existing and proposed research facilities,
resources, and study sites.  Documentation of agreements to
participate on the part of consultants, study site personnel, or
officials of other institutions.
 
7 Reasonableness of the proposed budget and duration of the
research in relation to the research effort.
 
8 Adequacy of proposed means to protect against hazardous or
unethical procedures.  Completion of assurances to protect human
subjects.
 
The peer review group will recommend an appropriate budget and
period of support for each approved application.
 
Investigators should provide with the application, certification
of institutional review board (IRB) approval if human subjects
are involved and verification of the institutional animal care
and use committee (IACUC) approval if animals are involved.
These reviews and approvals should occur PRIOR TO SUBMISSION of
the applications for award and the certifications and
verifications should be SUBMITTED WITH the applications.  Failure
to provide required certifications and verifications within
applications could result in deferral or rejection.  If animals
or humans will be subjects of the research at PERFORMANCE SITES
OTHER THAN THE APPLICANT ORGANIZATION, the applicants must
identify, within the application, the assurance status of each
participant.  Failure to provide this information within
applications could result in deferral or rejection.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by March 20, 1991, 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 the title of the RFA in response
to which the application is being submitted.
 
Although a letter of intent is not required, is not binding, and
does not enter into the review of subsequent applications, it is
requested in order to provide an indication of the number and
scope of applications to be reviewed.
 
The letter of intent should be sent to:
 
Anne R. Bavier, M.N., F.A.A.N.
Program Director, CORB, EDCOP, DCPC
National Cancer Institute
Executive Plaza North, Room 300-E
Bethesda, MD  20892
Telephone:  (301) 496-8541
 
METHOD OF APPLYING
 
The research grant application form PHS 398 (Revised 10/88) must
be used in applying for these grants.  These forms are available
at most institutional business offices; from the Office of Grants
Inquiries, Division of Research Grants, National Institutes of
Health, Room 449, Westwood Building, 5333 Westbard Avenue,
Bethesda, Maryland 20892; and from the NCI Program Director named
above.
 
The RFA label available in the 10/88 revision of Application Form
398 must be affixed to the bottom of the face page.  Failure to
use this label could result in delayed processing of your
application such that it may not reach the review committee in
time for review.  In addition, the RFA number and title should be
typed on line 2 of the face page of the application form.
 
Submit a signed, typewritten original of the application,
including the Checklist, and four (4) signed, exact photocopies,
in one package to the address below.  The photocopies must be
clear and single sided.
 
DIVISION OF RESEARCH GRANTS
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
At time of submission, send two (2) additional copies of the
application to:
 
REFERRAL OFFICER
Division of Extramural Activities
National Cancer Institute
Westwood Building, Room 848
5333 Westbard Avenue
Bethesda, MD  20892
 
Applications must be received by May 20, 1991.  If an application
is received after that date, it will be returned.  If the
application submitted in response to this RFA is substantially
similar to a research grant application already submitted to the
NIH for review, but has not yet been reviewed, the applicant will
be asked to withdraw either the pending application or the new
one.  Simultaneous submission of identical applications will not
be allowed, nor will essentially identical applications be
reviewed by different review committees.  Therefore, an
application cannot be submitted in response to this RFA that is
essentially identical to one that has already been 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.
 
INQUIRIES
 
Written or telephone inquiries concerning the objectives and
scope of this RFA or inquiries about whether or not specific
proposed research would be responsive are encouraged and should
be directed to the program director named in Section VIII, Letter
of Intent.  The program director welcomes the opportunity to
clarify any issues or questions from potential applicants.
 
This program is described in the Catalog of Federal Domestic
Assistance Number 93.399, Cancer Control.  Awards will be made
under the authority of the Public Health Service Act, Title IV,
Section 301 (Public Law 78-410, 42 U.S.C. 241, and Section 412,
as amended by Public Law 99-158, 42 U.S.C. 258a-1) 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.