Full Text CA-93-035

CANCER PAIN MANAGEMENT IN THE OUTPATIENT SETTING

NIH GUIDE, Volume 22, Number 26, July 23, 1993

RFA:  CA-93-035

P.T. 34

Keywords: 
  Cancer/Carcinogenesis 
  Pain 


National Cancer Institute

Letter of Intent Receipt Date:  August 12, 1993
Application Receipt Date:  November 16, 1993

PURPOSE

The Division of Cancer Prevention and Control (DCPC) of the National
Cancer Institute (NCI) invites  investigator- initiated grant
applications for research directed at developing and testing
interventions to improve the management of cancer pain outside of the
acute care or hospice settings, thereby improving the quality of life
of persons with cancer living at home or being managed on an
out-patient basis.

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), Cancer Pain Management in the Outpatient
Setting, 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 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, for-profit and
non-profit, public and private organizations, such as universities,
colleges, hospitals, laboratories, units of state and local
governments, and eligible agencies of the Federal government.
Applications from minority individuals and women are encouraged.

MECHANISM OF SUPPORT

Support of this program will be through the National Institutes of
Health (NIH) individual research project grant (R01).  Applicants will
be responsible for the planning, direction, and execution of the
proposed project.  The total project period for applications submitted
in response to this RFA may not exceed four years.  Except as otherwise
stated in this 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.

Because the nature and scope of the research proposed in response to
this RFA may vary, it is anticipated that the size of an award will
vary also.  The anticipated amount of the direct costs per award will
vary from $100,000 to $300,000.  Allowable direct costs for the
intervention will NOT include payment for cancer screening tests or
services and procedures which are a routine part of cancer treatment
and patient care.  Expenses incurred in development and implementation
of the proposed research, including baseline and follow-up surveys,
design of materials, and professional education are allowable costs.
Budgets should include travel funds for the Principal Investigator and
co-investigator to one two-day meeting in Bethesda, MD, in year four to
facilitate review with  program staff and to foster sharing of work in
progress with other researchers.

This RFA is a one-time solicitation.  Future unsolicited competitive
continuation applications will compete with all other
investigator-initiated research grant applications and be peer reviewed
by a chartered study section in the Division of Research Grants (DRG),
NIH.  However, if the NCI determines 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.

FUNDS AVAILABLE

Total costs of $1,500,000 per year for four years will be committed to
specifically fund applications that are submitted in response to this
RFA.  It is anticipated that five awards will be made.  This funding
level is dependent upon the receipt of a sufficient number of
applications of high scientific merit.  The earliest feasible start
date for the initial awards will be July 1994.  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.

RESEARCH OBJECTIVES

Background

Effective cancer pain management is a topic that continues to receive
much attention.  Undertreatment of pain of all types, in all age
groups, has been apparent for almost two decades.  There is agreement
that the scientific basis for effective pain management exists, but
that the dissemination of information and transfer to clinical practice
has not kept up with the science.  The focus has been most often on the
acute care setting or effective palliation in the hospice setting.

Current practice in oncology settings is shifting from the acute care
cancer center to outpatient and community settings for continuing care,
maintenance, and follow-up.  Many patients who are followed in these
settings are those with pain from bone metastases of breast or prostate
cancer.  These patients are relatively healthy and can manage the usual
activities of daily living.  They would have a greater comfort level
and greater quality of life if their pain were managed optimally.  The
shift in care setting results in many patients with cancer being
managed by primary care physicians, home health care providers, and
others not associated with cancer care.

The current literature addresses concerns with management of cancer
pain in the acute care and hospice settings.  Families are assuming the
responsibility for pain management at home.  Ferrel et al (1,2 )
recently reported that family members play an important role in pain
management.  This is increasingly true in an era of health care cost
containment.  Advances in technology now require that families manage
complex medication regimens, parenteral infusion devices and even
epidural catheters in the home.  The management of pain for those
individuals who are at home, cared for by a family member, a community
physician and/or visiting nurse or other health care provider outside
of major cancer centers has not had the same attention as pain
management in acute care settings and hospice.  There are attitudinal
influences, legal barriers or obstacles, knowledge deficits by the
professional as well as the lay care givers that contribute to less
than optimal pain management in these settings.

The 1989 conference "Drug treatment of cancer in a drug oriented
society" (4) produced a consensus that ... "Despite more knowledge
about pain and wider dissemination of that knowledge through
conferences and volumes such as this, progress in improving the quality
of pain treatment in cancer patients has been inadequate, resulting in
many cancer patients suffering needlessly" (3, 4).  The reasons for the
problem can be divided into three categories according to Hill et al:
(1) cultural and attitudinal barriers to rational and appropriate use
of narcotics; (2) knowledge deficits about pain and narcotics; (3)
influence of drug regulatory agencies.  The first two reasons are
within the scope of this RFA, the last is beyond this announcement.

Research Goals and Scope

The goals of this research initiative are to develop and test
interventions to improve the management of cancer pain outside of the
acute care or hospice settings, thereby improving the quality of life
of persons with cancer living at home or being managed on an
out-patient basis.

The specific objectives of the research are to:

o  test interventions to promote the transfer of technology in a
variety of health care delivery systems to improve knowledge about pain
management for cancer patients living at home.

o  evaluate interventions to address patient and health care provider
factors that are barriers to effective transfer and use of state-of-
the-art cancer pain management techniques.

o  improve the acceptability and use of the pain control strategies
through improved management of the side effects of analgesics and/or
modifications of attitudes towards the use of narcotics for pain
management.

The application should define the population, identify the problem,
describe the intervention, and outline the evaluation plan.
Applications should reflect a strong research orientation with
attention to quality of life and its dimensions reflected by
effectiveness of pain management, patient satisfaction or other
appropriate end points.  A multidisciplinary approach including
expertise in cancer pain management, clinical oncology, nursing, social
work, and health services research is recommended.

Study Design

This is a request for applications for research that will develop and
test interventions for the delivery of appropriate and effective pain
management to cancer patients outside of acute care and hospice
settings.  The settings where this intervention could be tested include
in-home care, out-patient based care for patients experiencing chronic
pain from metastatic disease or the sequelae of disease or therapy, or
acute pain episodes during a more stable course of disease.

The proposed interventions should build on current knowledge and
research findings that indicate appropriate pain management approaches
in different types of pain etiology (i.e., bone pain from metastatic
disease such as from breast or prostate cancer, or neurogenic pain from
surgery, other therapy or disease progression) as well as using
different drug combinations for optimum effect.  This is not to be
structured as a clinical trial of drug effectiveness, nor as a
comparison of the acceptability or effectiveness of competitive drug
delivery techniques.

Some examples of target areas for the development of interventions
might include, but are not limited to, the following:

o  Effects of patient concerns, patient choices, decision making
strategies, and care giver values on effective pain management.

o  Impact of systematic use of clinical practice guidelines and
documentation of the effect of the intervention on patient care
outcomes.

o  Overcoming barriers to application of state of the art knowledge
about cancer pain management, (attitudes of the health care provider;
feasibility, cost effectiveness and effectiveness of hi-tech vs.
low-tech delivery techniques for the drugs in outpatient settings;
structure of the care delivery system).

o  Interface of ethical and legal codes and the effect of adherence to
each on the quality of pain management outside of the acute care
setting.

The cultural, ethnic, and developmental aspects of the population
targeted for study must be considered in designing interventions.
Validation of established assessment guides in low literacy and
non-English speaking populations should be considered as part of a
broader intervention where appropriate.  Biological and behavioral
variables should be included as appropriate to the research question.
The inclusion of biological variables that can be measured directly is
encouraged.  This will require collaboration across disciplines and the
inclusion of community care givers and primary care providers on the
research team.

This intervention research may incorporate a descriptive phase for
collection of baseline data, or a short pilot phase for refining the
proposed intervention.  Applicants are expected to have a foundation of
previous work so that only a minimal descriptive, exploratory phase
will be required before moving to the intervention and evaluation
phases.

Study Evaluation

A strong evaluation component is required.  Existing measures of the
outcome variables of interest, with established validity and
reliability, must be used.  The investigators will be expected to
evaluate the feasibility and effectiveness of the transfer of
technology from the traditional care settings to the out-patient,
community or home setting.  This includes assessing patient outcomes,
the efficiency of the intervention with respect to use of community
resources, considerations of the costs incurred, and mechanism of
payment.  A multidisciplinary approach to the research question and to
the evaluation of the intervention is recommended.

Outcomes can include measures of satisfaction with pain control,
changes in level of pain reported either subjectively or by biological
means; functional status (cognitive and/or physical); duration of
response; changes in reported quality of life; compliance with or
persistence in cancer therapy when pain management is optimal;
effectiveness of the care delivery model in the target group;
influences of health care provider characteristics and attitudes on
adequate pain management in the target group; convenience and cost.

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 and
cooperative agreements are required to include minorities and women in
study populations so that research findings can be of benefit to all
persons at risk of the disease, disorder or condition under study;
special emphasis must 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 and compelling rationale must be
provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues must be addressed in developing a research design
and sample size appropriate for the scientific objectives of the study.
This information must be included in the 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 assess carefully the feasibility of including
the broadest possible representation of minority groups.  However, the
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 is defined as 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 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 the NIH are
required to address these policies.  NIH funding components will not
award grants or cooperative agreements that do not comply with these
policies.

LETTER OF INTENT

Prospective applicants are asked to submit, by August 12, 1993, a
letter of intent that includes a descriptive title of the proposed
research; the name, address, telephone and FAX numbers of the Principal
Investigator; the names of other key personnel; the participating
institution(s); 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 a subsequent application, it contains
information that is helpful in planning for the review.  The letter of
intent allows NCI staff to estimate the potential review workload and
helps to avoid conflict of interest in the review.

The letter of intent is to be sent to Dr. Claudette Varricchio, 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.  The application package is available at
most institutional offices of sponsored research; from the Office of
Grants Information, Division of Research Grants, National Institutes of
Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone
301-710-0267; and from the NCI Program Director listed under INQUIRIES.

The RFA label available in the application form PHS 398 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 number and title must 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 be sent to:

Ms. Toby Friedberg
Referral Officer, Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 636
Bethesda, MD  20892

If the applicant has an approved assurance covering the research, the
applicant must provide, with the application, certification of
Institutional Review Board (IRB) approval, if humans are involved.
Reviews and approval should occur prior to submission of the
application for award and the certification should be submitted with
the application.  If humans will be subjects of the research at
performance sites other than the applicant organization, the applicant
must identify, in the application, the assurance status of each
participant.  Failure to provide required certifications in the
application could result in delay of an award.  Instructions regarding
inclusion of human subjects are given on pages 22-23 and 25-26 of PHS
398 (rev. 9/91).

Applications must be received by close of business November 16, 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 a substantial revision to an
already reviewed application, but such an application must include an
introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Review Procedure

Upon receipt, applications will be reviewed initially by the DRG for
completeness.  An incomplete application 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, but may be submitted as investigator-initiated
research grant applications at the next regular receipt date.
Questions concerning the relevance of proposed research to the RFA may
be directed to the Program Director listed under INQUIRIES.

If 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
triage applications on the basis of relative competitiveness and to
eliminate those applications that are clearly not competitive.  The NCI
will withdraw from further competition those applications judged to be
noncompetitive 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 for NCI will
consider the special needs and the research priorities of the
Institute.

Review Criteria

Applications responsive to this competitive solicitation will be
reviewed in accordance with the criteria stated below:

o  Scientific merit of the research design, clinical significance and
originality of the proposed intervention.

o  Appropriateness and adequacy of the experimental approach and
methodology proposed to the goals and objectives of the RFA, including
outcome measures and the feasibility of the procedure to be used.

o  Appropriateness of the study population to the goals and objectives
of the RFA and investigator access to the study population.

o  Qualifications and research experience of the Principal Investigator
and staff, particularly, but not exclusively, in the area of the
proposed research.  Inclusion of professionals representing diverse
disciplines, as appropriate, on the leadership level.

o  Availability of resources necessary to perform the research.

o  Feasibility of applying successful interventions in community
practice settings and home care settings.

o  Adequacy of the proposed means for protecting against hazardous or
unethical research procedures.

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

AWARD CRITERIA

The earliest anticipated date of award is July 1, 1994.

The following factors will be considered in making funding decisions:
(1) the scientific merit of the proposed project as determined by peer
review; (2) availability of funds; and (3) program balance among
research areas of the RFA.

INQUIRIES

Written and telephone inquiries concerning the objectives and scope of
this RFA, and inquiries about whether or not specific proposed research
would be responsive, are encouraged.  The opportunity to clarify any
scientific or programmatic issues or questions from potential
applicants is welcome.

Direct inquiries regarding programmatic issues and address the letter
of intent to:

Claudette Varricchio, D.S.N., R.N., O.C.N., F.A.A.N.
Division of Cancer Prevention and Control
National Cancer Institute
Executive Plaza North, Suite 300
Bethesda, MD  20892
Telephone:  (301) 496-8541
FAX:  (301) 496-8667

Inquiries regarding budgetary, administrative, and/or policy issues may
be directed to:

Mrs. Crystal Elliott
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Suite 242
Bethesda, MD  20892
Telephone:  (301) 496-7800, ext. 19
FAX:  (301) 496-8601

Other institutes and agencies are also interested in research focused
on cancer pain management.  These include the National Institute for
Nursing Research.  Inquiries may be directed to:

June R. Lunney, Ph.D., R.N.
Acute and Chronic Disease Branch
National Center for Nursing Research
Building 31, Room 5B09
Bethesda, MD  20892
Telephone:  (301) 594-7397

This RFA is in addition to the ongoing program announcement on Cancer
Prevention and Control Research, published in the NIH Guide for Grants
and Contracts, Vol. 21, No. 12, March 27, 1992.

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance
No. 93.399, Cancer Control Research, and 93.361, Nursing Research.
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 52 and 45 CFR Part 74 and 45 CFR 92.
This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review.
References

1.  Ferrel BR, Ferrel BA, Rhimer M, Grant MM.  1991, Family Factors
Influencing Cancer Pain.  Pst Graduate Medical Journal 67(Supple 2):
S64-S69.

2.  Ferrel BR, Ferrel BA. 1991, Pain Management at Home.  Clinics in
Geriatric Medicine  18(8): 1315- 1321.

3.  Hill CS. 1990, Relationship Among Cultural, Educational, and
Regulatory Agency Influences on Optimum Cancer Pain Treatment.  Journal
of Pain and Symptom Management  5(1) (sup): S37-S45.

4.  Hill CS, Fields WS.  1989,  Advances in Pain Research and Therapy
Volume 11: Drug Treatment of Cancer Pain in a Drug-Oriented Society.
Raven Press, New York.

5.  Hill CS, Fields WS, Thorpe DM.  1989, A Call to Action to Improve
Relief of Cancer Pain, in, Advances in Pain Research and Therapy Volume
11: Drug Treatment of Cancer Pain in a Drug-Oriented Society, Hill CS,
Fields WS, (eds).  Raven Press, New York: 353-361.

6.  Foley KM, Bonica, JJ, Ventafridda V,eds. 1990, Advances in Pain
Research and Therapy, Vol. 16: Proceedings of the Second International
Congress on Cancer Pain.  Raven Press, New York.

7.  Pratt, RB. 1993, Cancer Pain.  JB Lippincott, Philadelphia.

8.  Portenoy, R, Foley, K. 1989, Management of Cancer Pain, in,
Handbook of Psychooncology, Holland, JC, Rowland, JH, eds.  Oxford
University Press, New York: 369-382.

9.  Schmitt, RM. 1992, Outpatient Cancer Pain Management:  Issues in
Research and Practice.  Pain Management Issues in Research and
Practice. American Cancer Society Pub. No. 50M 4503, 05 PE, Atlanta,
GA.

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