REHABILITATION AND PSYCHOSOCIAL RESEARCH IN YOUNGER WOMEN WITH BREASTCANCER NIH GUIDE, Volume 22, Number 26, July 23, 1993 RFA AVAILABLE: CA/HD-93-033 P.T. 34 Keywords: Cancer/Carcinogenesis Rehabilitation/Therapy, Emotional Rehabilitation/Therapy, Physical Social Psychology National Cancer Institute National Institute of Child Health and Human Development Letter of Intent Receipt Date: August 31, 1993 Application Receipt Date: November 9, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE The Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI) and the National Center for Medical Rehabilitation Research (NCMRR), National Institute of Child Health and Human Development (NICHD) invite investigator-initiated grant applications for research directed at decreasing the medical and psychological morbidity and disability associated with breast cancer diagnosis and treatment in younger women. Applications must develop and test interventions that address health issues, psychosocial problems, and potential disability faced by women diagnosed with breast cancer during early adult life. 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 RFA, Rehabilitation and Psychosocial Research in Younger Women with 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 202-783-3238. ELIGIBILITY REQUIREMENTS 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. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research project grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to this RFA may not exceed four years. The anticipated award date is July 1, 1994. Because the nature and scope of research proposed in response to this RFA may vary, it is anticipated that the size of award will vary also. The anticipated amount of the direct costs per award will vary from $100,000 to $400,000. This RFA is a one-time solicitation. Future unsolicited competitive continuation applications will compete with all investigator-initiated and be reviewed according to the customary NIH peer review procedures. FUNDS AVAILABLE Total costs of $2,400,000 per year for four years will be committed to specifically fund applications that are submitted in response to this RFA. It is anticipated that four to seven awards will be made. RESEARCH OBJECTIVES The goal of this RFA is to enhance the quality of life of younger women with breast cancer. Objectives are to: (1) identify and describe the medical, psychosocial, and disability-related sequelae of breast cancer diagnosis and treatment in younger women and (2) develop and test interventions directed at the specific problems associated with breast cancer diagnosis and treatment in this age group. Projects will develop, implement, and evaluate interventions directed at problems including (1) medical sequelae of therapy; (2) body image, sexuality, and reproductive issues; (3) interpersonal and family relationships; (4) concrete needs; (5) education, career development/advancement, employment, and insurance; (6) living with medical uncertainty; (7) special needs of younger patients during periods of progressive disease and/or terminal care; or (8) the impact of ethnic and cultural factors on issues listed above. Younger women are defined by chronologic age (<50 years) or by menopausal status (pre- and/or peri-menopausal) at diagnosis and study entry, depending on the study intervention. Formal evaluation of efficacy is required, with outcome variables of health-related quality of life (QOL), domains reflecting medical and psychological morbidity, and relevant aspects of disability, such as personal productivity and community participation. A multidisciplinary research approach is recommended. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women and minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by August 31, 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 identities of other key personnel and the participating institutions; and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, it contains information that is helpful in planning for the review. The letter of intent allows NCI and NICHD 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. Susan G. Nayfield 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. Applications must be received by close of business November 9, 1993. REVIEW CONSIDERATIONS Applications responsive to this competitive solicitation will be reviewed according to the following criteria: (1) scientific merit, clinical significance and originality, and feasibility of the proposed research; (2) appropriateness and adequacy of the research approach and proposed methodology to the goal and objectives of the RFA; (3) appropriateness of the study population and inclusion of or direction of research toward special populations; (4) feasibility of interventions for the community setting; (5) qualifications and experience of the Principal Investigator and staff; (6) use of multidisciplinary expertise from related health care specialty fields (7) adequacy of facilities and resources; and (8) adequacy of protection from hazardous or unethical research procedures. Scientific merit, availability of funds, and program balance among research areas will be considered in funding decisions. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA, inquiries regarding programmatic issues, and address the letter of intent to: Susan G. Nayfield, M.D., M.Sc. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 300-F Bethesda, MD 20892 Telephone: (301) 496-8541 Louis A. Quatrano, Ph.D. National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 2A-0 Bethesda, MD 20892 Telephone: (301) 402-2242 FAX: (301) 402-0832 Direct inquiries regarding fiscal matters to: Ms. Victoria Price Grants Administration Branch National Cancer Institute Executive Plaza South, Suite 243 Bethesda, MD 20892 Telephone: (301) 496-7800, Ext. 52 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399, Cancer Control 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. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. .
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