Full Text PA-97-082
 
MANAGEMENT OF SYMPTOMS SECONDARY TO TREATMENT
 
NIH GUIDE, Volume 26, Number 24, July 25, 1997
 
PA NUMBER: PA-97-082
 
P.T.


Keywords: 

 
National Institute of Nursing Research
National Cancer Institute
National Institute of Mental Health
 
PURPOSE
 
The National Institute of Nursing Research (NINR), the National
Cancer Institute (NCI), and the National Institute of Mental Health
(NIMH) seek research applications concerning the clinical management
of treatment-associated symptoms.  The purpose of this initiative is
to stimulate research that will lead to improved adherence to
treatment regimens and better quality of life by the development and
testing of strategies to decrease the negative impact of physical and
psychosocial symptoms that are the secondary result of treatment or
prevention regimens.
 
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 Program
Announcement (PA), Management of Symptoms Secondary to Treatment, is
related to all preventive services. 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 202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Research applications may be submitted by domestic and foreign, for-
profit and non-profit organizations, public and private, such as
universities, colleges, hospitals, laboratories, units of State and
local governments, and eligible agencies of the Federal government.
Foreign institutions are not eligible for First Independent Research
Support and Transition (FIRST) (R29) awards. Racial/ethnic minority
individuals, women, and persons with disabilities are encouraged to
apply as Principal Investigators.
 
MECHANISM OF SUPPORT
 
The mechanisms of support will be the National Institutes of Health
(NIH) research project grants (R01) and FIRST awards (R29),
Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant.
 
BACKGROUND
 
Preventive and treatment regimens often cause uncomfortable,
disabling, or even life-threatening secondary clinical problems.  In
some cases, effective management of such responses is necessary to
permit individuals to undergo the appropriate intensity and duration
of the regimen.  For example,  control of nausea and vomiting is
essential in the management of many cancer patients undergoing
chemotherapy in order to administer sufficient therapy to cure or
slow the progression of the disease.  In other situations,  such as
with the use of some antibiotics, gastrointestinal disturbances may
not be life-threatening but are sufficiently disruptive and annoying
to cause individuals to decide not to take medications as prescribed.
The results of such incomplete treatment may include the development
of resistant pathogens, wasted health care resources, and inaccurate
information about treatment efficacy. Simultaneous with research
directed toward the elimination of side effects by the formulation of
better therapies, research is needed to develop interventions to
better manage side effects and reduce their negative impact on
treatment completion and quality of life.
 
The secondary symptoms of treatment regimens that affect adherence
and quality of life are diverse.  A few examples include mental
status and behavioral changes associated with seratonin agonists,
postural sway found with benzodiazepines,  involuntary movements
common with neuroleptic therapy, skin yellowing attributed to beta-
carotene,  bleeding associated with estrogen replacement therapy, and
constipation noted with iron supplementation. The focus of this
research initiative is on those situations in which secondary
symptoms are disruptive but not life-threatening and where nurse-
initiated interventions could contribute to reducing the distress,
thereby increasing adherence and quality of life.
 
Behavioral interventions have been demonstrated to reduce the impact
of treatment induced symptoms.  For example, systematic
desensitization has been effective in reducing chemotherapy-induced
nausea and vomiting. (1) Aerobic exercise has been demonstrated to
attenuate adverse changes in mood states and anxiety associated with
taking beta blockers.  (2)  The development and testing of
interventions that may be used to reduce symptom frequency, severity,
and duration is an important goal of this initiative.
 
Symptom distress, a subjective evaluation of the impact of a symptom
on function and quality of life, is also important. The same degree
of a physical sensation or the same frequency or duration of an
adverse event may cause different levels of distress in different
individuals or in the same individual at different times.  An
important component of reducing secondary symptom distress may found
in the interaction between the health care provider and the
individual experiencing the symptom.  Research is needed to better
understand the effect of different counseling and coaching styles on
individuals' self management abilities, such as the capacity to
tolerate unpleasant experiences or the motivation to creatively
modify daily routines to minimize the impact of annoying side
effects.  Interventions designed to enhance shared decision making
between health care providers and patients could be evaluated to
determine if they affect the subjective response to drug side effects
and treatment adherence.
 
OBJECTIVES
 
Specific areas of interest include the following topics:
 
o studies of the efficacy of nonpharmacologic or multi-modal
management strategies to alleviate physical or psychological side
effects of treatment regimens;
 
o studies of the efficacy of strategies to reduce the distress
associated with treatment side effects;
 
o basic and clinical studies to identify the basis of treatment-
related symptoms;
o small-scale studies to develop and test instruments that are
sensitive to the distress associated with secondary symptoms and
patterns over time;
 
o studies that demonstrate the impact of secondary symptoms on
treatment adherence and quality of life;
 
The National Institute of Mental Health interest in these studies is
limited to those  involving patients with HIV.
 
Projects may be descriptive or experimental.  With adequate
justification of knowledge gaps, data may be collected that will
enhance the development of clinical interventions. However, where
possible, interventions which are designed to reduce the severity,
frequency, duration or distress of secondary symptoms should be
evaluated for efficacy under conditions that will permit
comprehensive analysis of appropriate outcome measures.  It is
imperative that proposed interventions not compromise the
effectiveness of the treatment regimen.  Interventions should also
have the potential for implementation into routine clinical practice.
 
Because of the complex interaction of clinical symptoms and the
associated subjective response, a multidisciplinary research approach
is recommended.  Expertise from health-related disciplines should be
included as appropriate for both the target symptom and the clinical
population.
 
Applicants are encouraged to make use of ongoing clinical trials or
other medical research efforts where feasible. Applications from
institutions that participate in ongoing clinical trials or have a
General Clinical Research Center (GCRC) may wish to identify these
programs as a resource for conducting the proposed research.  If so,
a letter of agreement from the program director or the Principal
Investigaor should  be included with the application.
 
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS
 
It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990. The new policy contains some
provisions that are substantially different from the 1990 policies.
 
All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.
 
Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.
 
APPLICATION PROCEDURES
 
Applications are to be submitted on grant application form PHS 398
(rev. 5/95) and will be accepted at the standard application
deadlines as indicated in the application kit. Application kits are
available at most institutional offices of sponsored research and may
be obtained from the Office of Extramural Outreach and Information
Resources, National Institutes of Health, 6701 Rockledge Drive, MSC
7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email:
[email protected].  The title and number of the program
announcement must be typed in Section 2 on the face page of the
application.
 
Applications for the FIRST Award (R29) must include at least three
sealed letters of reference attached to the face page of the original
application.  FIRST Award (R29) applications submitted without the
required number of reference letters will be considered incomplete
and will be returned without review.  FIRST  Award applications must
follow "just-in-time"  procedures as described in the NIH Guide,
Volume 25, Number 10, March 29, 1996.
 
The complete original application and five legible copies must be
sent or delivered to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)
 
REVIEW CONSIDERATIONS
 
Applications will be assigned on the basis of established PHS
referral guidelines.   Applications that are complete will be
evaluated for scientific and technical merit by an appropriate peer
review group convened in accordance with the standard NIH peer review
procedures.  As part of the initial merit review, all applications
will receive a written critique.  Applications will also undergo a
process in which only those deemed to have the highest scientific
merit, generally the top half of applications under review, will be
discussed, assigned a priority score, and receive a second level
review by the appropriate national advisory council or board, when
applicable.
 
Review Criteria for research grant applications:
 
The goals of NIH-supported research are to advance our understanding
of biological systems, improve the control of disease, and enhance
health.  In the written review, comments on the following aspects of
the application will be made in order to judge the likelihood that
the proposed research will have a substantial impact on the pursuit
of these goals.  Each of these criteria will be addressed and
considered in the assignment of the overall score:
 
(1)  Significance
 
Does this study address an important problem?  If the aims of the
application are achieved, how will scientific knowledge be advanced?
What will be the effect of these studies on the concepts or methods
that drive this field?
 
(2)  Approach
 
Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of
the project?  Does the applicant acknowledge potential problem areas
and consider alternative tactics?
 
(3)  Innovation
 
Does the project employ novel concepts, approaches or methods?  Are
the aims original and innovative?  Does the project challenge
existing paradigms or develop new methodologies or technologies?
 
(4)  Investigator
 
Is the investigator appropriately trained and well suited to carry
out this work?  Is the work proposed appropriate to the experience
level of the principal investigator and other researchers (if any)?
 
(5)  Environment
 
Does the scientific environment in which the work will be done
contribute to the probability of success?  Do the proposed
experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements?  Is there
evidence of institutional support?
 
In addition, the adequacy of plans to include both genders and
minorities and their subgroups as appropriate for the scientific
goals of the research will be reviewed.  Plans for the recruitment
and retention of subjects will also be evaluated.
 
The initial review group will also examine the provisions for the
protection of human and animal subjects, the safety of the research
environment, and conformance with the NIH Guidelines for the
Inclusion of Women and Minorities as Subjects in Clinical Research.
 
 AWARD CRITERIA
 
Applications will compete for available funds with all other approved
applications assigned to that institute or center. The following will
be considered in making funding decisions: quality of the proposed
project as determined by peer review, availability of funds, and
program priority.
 
INQUIRIES
 
Inquiries are encouraged.  We welcome the opportunity to clarify any
issues or questions from potential applicants.
 
Direct inquiries regarding NINR programmatic issues to:
June R. Lunney, PhD,  RN
Division of Extramural Activities
National Institute of Nursing Research
Building 45, Room 3AN-12
Bethesda, MD 20892-6300
Telephone: (301) 594-6908
FAX: (301) 480-8260
Email: [email protected]
 
Direct inquiries regarding NCI programmatic issues to:
Claudette G. Varricchio, DSN, RN,  FAAN
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
Email:  [email protected]
 
Direct inquiries regarding NIMH programmatic issues to:
Dianne Rausch, PhD
Office on AIDS
National Institute of Mental Health
Parklawn Building, Room 10-75
Rockville, MD 20857
Telephone: (301) 443-6100
FAX: (301) 443-7274
 
Direct inquiries regarding NINR fiscal matters to:
Jeff Carow
Grants Management Officer
National Institute of Nursing Research
Building 45, Room 3AN-12
6300 Center Drive MSC 6301
Bethesda, MD  20892-6301
Telephone:  (301) 594-6869
FAX:  (301) 480-8260
Email:  [email protected]
 
Direct inquiries regarding NCI fiscal matters to:
Robert E. Hawkins, Jr.
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD 20892
Telephone:  (301) 496-7800 Ext. 213
FAX:  (301) 496-8601
Email: [email protected]
 
Direct inquiries regarding NIMH fiscal matters to:
Diana S. Trunnell
Assistant Chief, Grants Management Branch
National Institute of Mental Health
Parklawn Building, Room 7C-08
Rockville, MD 20857
Telephone: (301) 443-2805
FAX: (301) 443-6885
Email:  [email protected]
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.361 (NINR), No. 93.399 (Cancer Control Research),
and 93.242 (NIMH).  Awards are made under 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.
This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency
review.
 
The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education,
library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.
 
(1) Morrow GR: Behavioural factors influencing the development and
expression of chemotherapy-induced side effects.  Br J Cancer 1992;
66 (suppl XIX) S54-S61). (2) Head A; Kendall MJ; Ferner R; Eagles C:
Acute effects of beta blockade and exercise on mood and anxiety.  Br
J Sports Med 1996 Sep;30(3): 238-42.
 
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