Full Text PA-96-034
 
AGING WOMEN AND BREAST CANCER
 
NIH GUIDE, Volume 25, Number 12, April 19, 1996
 
PA NUMBER:  PA-96-034
 
P.T. 34

Keywords: 
  Aging/Gerontology 
  0715036 
  Epidemiology 
  Behavioral/Social Studies/Service 
  Clinical Medicine, General 

 
National Institute on Aging
National Cancer Institute
National Institute of Nursing Research
National Institute of Mental Health
 
PURPOSE
 
The National Institute on Aging (NIA), the National Cancer Institute
(NCI), the National Institute of Nursing Research (NINR), and the
National Institute of Mental Health (NIMH) invite research
applications to focus on the unique problems of older women with
breast cancer.  Breast cancer affecting elderly women is a major
health problem.  The purpose of this broad-based program announcement
is to expand the knowledge base on breast cancer in older women
through studies in the fields of biology, clinical medicine,
epidemiology, and the behavioral and social sciences.
 
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 PA,
Aging Women and Breast Cancer, 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
202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by foreign and domestic 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 the research program
project or First Independent Research Support and Transition (FIRST)
awards (R29).  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 investigator-initiated research
project grant (R01) and FIRST award (R29).
 
RESEARCH OBJECTIVES
 
Background
 
Of the 182,000 breast cancer patients diagnosed in 1994, 91,000 were
women 65 years or older (American Cancer Society, 1994). As national
incidence and mortality data show, aging is an important risk factor
for breast cancer.  Age- adjusted rates reported by the National
Cancer Institute Surveillance, Epidemiology, and End Results (SEER)
Program reveal that women 65 years or older have an incidence rate of
444.7 per 100,000 population as compared to 72.8 per 100,000 for
women under 65 years of age.  The peak breast cancer incidence rate
of 483.9 per 100,000 is in the age group 75-79 years.  The breast
cancer mortality rate for women under 65 years of age is 16.6 per
100,000 as compared to the rate for women 65 years and older which is
125.8 per 100,000.  The peak mortality rate is 191.0 per 100,000 for
women 85 years and older (SEER, 1994).
 
This population-based epidemiologic evidence demonstrates the
disproportionate number of older-aged women afflicted with breast
cancer.  Yet, there is insufficient information on biological
mechanisms affecting the onset and progression of cancer in older
women, recommended treatment, response of older women to cancer risks
and symptoms, individual and family coping with breast cancer, and
survival outcome (including quality of life).  The dearth of data on
these issues makes it difficult to provide answers to the many
questions that arise about breast cancer in older women.
 
The problems of breast cancer and its association with advanced age
have not been adequately addressed.  Breast cancer prevention, early
detection, and management in older women may be complicated by the
presence of other diseases, age-associated problems, and risk
factors.  No comprehensive guidelines for prevention, diagnosis,
pretreatment evaluation, or treatment have been formulated which take
into account the multiple health problems and recurrent medical,
economic, and social needs of women age 65 and older who survive
breast cancer or are newly diagnosed with the disease. Although older
women are less likely to engage in cancer prevention practices such
as mammography screening, little research has promoted the
development of strategies to improve either patient or physician
behavior to encourage communication about cancer prevention.
Sufficient data on the treatment of elderly women with breast cancer
are not available from clinical trials.  With the changing age and
ethnic profiles in the United States which project an expansion of
the aged female population in coming decades, there is an even
greater need to address the problems of breast cancer control for
older women.
 
The targeted areas of research relevant to this multidisciplinary
solicitation are identified below.
 
Biology --- Age-related factors in carcinogenesis.  Applicants are
encouraged to focus on biological factors that contribute to the
increased incidence of breast cancer in older women and/or affect
treatment outcome.  The following examples are illustrative, but not
exclusive:
 
o  The control of repair and cell death "programs," and how that
relates to cell senescence, aging and cancer (e.g., research on BPH,
caloric restriction, lymphocyte selection, cell loss);
 
o  Any age-related biological factors that affect the initiation,
promotion, or treatment of cancer, including protein or gene therapy
(e.g., research on control of telomerase expression, oxidative
damage, mitochondrial function);
 
o  Age-related differences in invasion and metastases of breast
cancer in older women;
 
o  Cell senescence in breast tissue, and age-related changes in gene
expression affecting predisposition to cell immortalization;
 
o  Age-related differences in drug sensitivity and metabolism;
 
o  Age-related changes in sensitivity to systemic and local hormones,
growth factors, and cytokines on breast cell proliferation and
carcinogenesis;
 
o  Age-related changes in secretion of hormones, growth factors, and
cytokines by breast tissue which act in a paracrine manner to alter
the secretion of growth-promoting factors from nearby adipose and
stromal tissues.
 
Of major interest to the NIMH are:
 
o Age-related differences in stress, pain, and mood which contribute
to the functional impairment of neuroendocrine, neuroimmunology, and
neurotransmitter systems.
 
Clinical Medicine --- The full range of prevention and treatment
issues that involve screening, early detection, diagnosis,
perioperative and/or postoperative management, adverse physical
influences on surgical outcome, and influence of age on
physician/surgeon treatment decisions for operative risk. Research
questions centering on these processes may be addressed individually
or combined.  While related issues designated by the applicant will
be considered, the following topics are of major interest to the NIA,
NCI, and NINR:
 
o  Testing new interventions or treatment strategies, in older women
especially, in the presence of patients' comorbid conditions to
reduce age-associated complications or lessen age-associated
reduction in treatment efficacy (as measured by treatment outcomes
such as quality of life, functional status, and/or survival
experience);
 
o  Age-associated and ethnicity-associated differences in breast
cancer treatment efficacy and effectiveness for such outcomes as
survival rates, treatment complications, side effects of treatment,
and functional status;
 
o  Factors responsible for differences in treatment received (e.g,
stage at diagnosis, presence of comorbid conditions, age selection
bias by physicians) and the effects of interactions among such
factors;
 
o  Special features of aging and/or symptoms of illness in old age
that influence the treatment and care of older-aged breast cancer
patients and relate to treatment differences or modifications made
because of old age;
 
o  Assessment of the effectiveness of different treatments relative
to the stage of disease and characteristics of old age (e.g., poor
repair mechanisms, functional loss, greater susceptibility to
toxicity of treatment);
 
o  Evaluation of tolerance and response to standard or experimental
adjuvant chemotherapy regimens or multimodality breast cancer
treatment interventions, controlling for physiologic parameters and
other factors;
 
o  Effects of age-associated, cultural, and life-style changes on
sensitivity, specificity, prognostic value, and predictive value for
treatment responsiveness, of breast cancer screening and diagnostic
techniques (e.g., mammography, MRI, gross and histopathologic breast
and lymph node biopsy measures, receptor assays).  Testing new
methods and technologies to reduce age-associated problems in
diagnosis and prognosis;
 
o  Barriers to recruitment of older women to breast cancer clinical
trials (e.g., comorbid conditions, physical frailty, lack of
transportation).
 
The NIMH encourages:
 
o  Studies designed to examine the impact of mental health
interventions on the treatment outcomes and treatment costs for
comorbid breast cancer in older women, with a focus on special
populations (e.g., oldest-old, nursing home populations, minorities,
older women diagnosed with genetic markers);
 
o  Exploration of the interaction of aging, the pharmacodynamics and
pharmacokinetics of medications (e.g., anti-estrogen therapeutics and
other types of chemotherapy) used to treat breast cancer, on mood and
other measures of mental status in older women.
 
Epidemiology --- Studies in the context of aging and/or old age that
(1) investigate risk factors in cancer etiology, (2) evaluate methods
of prevention, (3) elucidate the pattern of breast cancer as an
illness for patients, and (4) improve clinical effectiveness of the
diagnostic and management processes for older-aged women breast
cancer patients.  Studies may focus on the etiology of breast cancer
in combination with data from other disciplines such as genetics and
molecular epidemiology, or on issues in epidemiology and clinical
practice that represent pressing clinical problems.
 
o  Relationships and interactions of aging and age to breast cancer
risk (e.g., relative prominence of various physiologic and etiologic
risk factors at different ages, factors affecting risk and age of
onset of breast cancer in high-risk individuals);
 
o  Improved methods to identify high risk older women through
development of new techniques to distinguish premalignant changes
from nonmalignant age-associated changes in breast tissue;
 
o  Development of epidemiologic approaches addressing the possible
role of related changes such as hormonal status, both endogenous and
exogenous (exercise, education, nutrition, and immune function) as
risk factors for breast cancer in women;
 
o  Prospective studies on the early detection, diagnosis, and
treatment of aged breast cancer patients;
 
o  Analyses of existing databases applicable and relevant to
addressing treatment of older women breast cancer patients. Emphasis
on older ethnic populations is encouraged;
 
o  Effects of previous and/or concurrent illnesses on breast cancer
treatment recommendations;
 
o  Occurrence of second breast cancer primaries: synchronous (two or
more cancers present at the same time) and/or metachronous (first
cancer followed by a second tumor at a later date);
 
o  Validation of new methodologies to identify high-risk older women;
 
o  Molecular epidemiology and epidemiologic studies of age- related
biological factors that affect the onset, progression, metastatic
behavior, and mortality outcome of breast cancer in older women;
 
Behavioral and Social Sciences --- Special concerns include health
behaviors and beliefs about aging and breast cancer, interactions
between health professionals and older people, effects of breast
cancer on psychosocial and physical functioning, sociodemographic
factors related to breast cancer prevention in older women, long-term
care for older women with breast cancer, and the complex interactions
among aging, breast cancer and psychosocial disease, and gender
influences.
 
Research is also needed on older people's attitudes toward breast
cancer and aging;  age differences in current cancer- related
behaviors (e.g., willingness to obtain or prescribe a mammogram);
strategies for encouraging doctor-patient interactions and treatment
decisions; and the effects of living with cancer in later life.
Researchers are invited to make age comparisons and to look at aging
processes across the life course.  Specific behavioral and social
research issues of interest are listed. Related issues will be
considered.
 
o  How age (e.g., aging processes or age-related attitudes or
behaviors) affects the diagnosis, treatment and care of persons with
breast cancer;
 
o  How age interacts with race, ethnicity, and socioeconomic status
(SES) to affect attitudes and behavior and consequent diagnosis,
treatment, and care;
 
o  Strategies for promoting behavioral change by older women and
their health care providers to increase preventive health behaviors,
and how to implement such changes on community-wide basis over long
periods of time (e.g., institutional and financial incentives as in
coverage for mammograms);
 
o  Social and behavioral processes and interventions in symptom
recognition of breast cancer, as well as interpretation and action
for cancer-related symptoms in older women;
 
o  Doctor/older patient interactions and their influence on breast
cancer-related behaviors.  Strategies for improving cancer related
communications, adherence to medical and life-style recommendations,
and encouraging appropriate health utilization and functional
outcomes;
 
o  Behavioral and social factors affecting cancer treatment decisions
(e.g., joint influence of age, SES, and race/ethnicity as well as
patient preferences, payer source, coverage);
 
o  Self-management interventions for coping with breast cancer, such
as increasing self- efficacy regarding cancer treatment and employing
pain management strategies;
 
o  Relationship of community and area level factors (e.g. location
and availability of preventive diagnosis and treatment services)
independent of, or in interaction with, sociodemographic and
psychosocial characteristics of older women that affect diagnosis,
treatment, self-care, and family caregiving;
 
o  Consequences of cancer in older women for household arrangements
and the provision of resources by family and social network members;
 
o  Strategies to reduce caregiver burden and how caregiving is
influenced by age, family and household structure and composition,
and the economic and social burdens caregiving imposes.
 
The NIMH invites applications on:
 
o Clarification of the relationships and interactions of aging,
biologic and psychosocial factors which contribute to the comorbidity
of breast cancer and mental disorders in older women (e.g., late
onset depression, early onset depression with recurrent episodes,
schizophrenia, etc.) and how these factors contribute to the course,
diagnosis and treatment of both illnesses.
 
DEFINITION OF "OLD AGE" OR "ELDERLY" FOR THIS PROGRAM ANNOUNCEMENT
 
This PA focuses in particular on women aged 65 years and older
because the highest cancer incidence and mortality rates are found in
this age group.  Also, women in their mid- seventies and older are
generally those most severely affected by breast cancer and are
already quite likely to have preexisting chronic conditions.
However, the definition of "old age" or "elderly" is flexible and
dependent on investigator- defined parameters. Applicants are
expected to identify what is meant by "old" in the context of their
research.  Age comparisons with younger women are appropriate and may
be included.
 
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 20, 1994 (FR 59 14508-14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.
 
Investigators 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 the grant application form PHS
398 (rev. 5/95) and will be accepted at the standard application
deadlines as indicated in the application kit.  Applications kits are
available at most institutional offices of sponsored research and may
be obtained from the Grants Information Office, Office of Extramural
Outreach and Information Resources, National Institutes of Health,
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone
301/435-0714, email:  ASKNIH@odrockm1.od.nih.gov.
 
The title and number of the program announcement must be typed in
line 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.
 
The completed original application and five legible copies must be
sent or delivered to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, SUITE 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)
 
Receipt dates for new Research Project Grants and FIRST Awards
applications are February 1, June 1, and October 1 of each year.
 
REVIEW CONSIDERATIONS
 
Applications will be assigned on the basis of established Public
Health Service referral guidelines.  Applications will be reviewed
for scientific and technical merit by study sections of the Division
of Research Grants, NIH (or by the review group of the relevant
Institute, Center, or Division), in accordance with the standard NIH
peer review procedures.  As part of the initial merit review, all
applications will receive a written critique and undergo a process in
which only those applications 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.
 
Review Criteria
 
o  Scientific, technical, or medical significance and originality of
proposed research;
 
o  Appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;
 
o  Qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;
 
o  Availability of the resources necessary to perform the research;
 
o  Appropriateness of the proposed budget and duration in relation to
the proposed research;
 
o  Adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.
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.
 
AWARD CRITERIA
 
Applications will compete for available funds with all other approved
applications assigned to that IC.  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.  The opportunity to clarify any issues or
questions from potential applicants is welcome.
 
Direct inquiries regarding programmatic issues to:
 
Rosemary Yancik, Ph.D.
Cancer Section, Geriatrics Program
National Institute on Aging
Building 31, Room 5C05
Bethesda, MD  20892
Telephone:  (301) 496-5278
FAX:  (301) 496-2793
Email:  YancikR@31.nia.nih.gov
 
Claudette G. Varricchio, DSN, RN, OCN, 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:  Varricci@dopcepn.nci.nih.gov
 
June R. Lunney, Ph.D., R.N.
Scientific Program Administrator
National Institute of Nursing Research
Building 45, Room 3AN12
Bethesda, MD  20892-6300
Telephone:  (301) 594-6908
FAX:  (301) 480-8260
Email:  Jlunney@ep.ninr.nih.gov
 
Enid Light, Ph.D.
Mental Disorders of the Aging Research Branch
National Institute of Mental Health
Parklawn Building, Room 18-105
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-1185
FAX:  (301) 594-6784
Email:  ELight@nih.gov
 
Direct inquiries regarding fiscal matters to:
 
Mr. Joseph Ellis
Grants and Contracts Management Office
National Institute on Aging
Gateway Building, Suite 2N212
7201 Wisconsin Avenue, MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-1472
FAX:  (301) 402-3672
Email:  EllisJ@gw.nia.nih.gov
 
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:  HawkinsR@gab.nci.nih.gov
 
Mr. Jeff Carow
Grants Management Office
National Institute of Nursing Research
Building 45, Room 3AN-32
Bethesda, MD  20892-6301
Telephone:  (301) 594-5974
FAX:  (301) 480-8256
Email:  JCarow@ep.ninr.nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.866, Aging Research, No. 93.399, Cancer Control
Research, No. 93.393, Cancer Cause and Prevention Research, No.
93.396, Cancer Biology Research, No 93.399, Cancer Treatment
Research, No. 93.361, Nursing Research, and No. 93.242, Mental Health
Research.  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.
 
.

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