Full Text CA-97-018 LONG-TERM CANCER SURVIVORS: RESEARCH INITIATIVES NIH GUIDE, Volume 26, Number 30, September 5, 1997 RFA: CA-97-018 (see reissuance RFA-CA-04-003) P.T. Keywords: National Cancer Institute Letter of Intent Receipt Date: October 24, 1997 Application Receipt Date: November 25, 1997 PURPOSE The National Cancer Institute invites research grant applications to identify important areas that have an impact on long term survivors of cancer. The purpose of this RFA is to support research that will lead to a decrease in the physiologic and psychological morbidity associated with long term (more than 5 years) survival after cancer treatment by addressing specific areas that affect cancer survivors to a greater extent than members of the population at large. Questions related to the experiences of the cancer survivor encompassing both physiologic and psychological variables are to be explored and interventions to promote positive outcomes evaluated where appropriate. This initiative is expected to provide information about the incidence and scope of the effects of cancer and its treatment on survivors, the relationship of treatment to late effects and to yield new insights about measures that are appropriate to the potential problems and needs of long term survivors. This RFA is not intended to address questions that explore differences between survivors and non-survivors that may be linked to mechanisms of disease progression or genetic predisposition. 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), Long-Term Cancer Survivors: Research Initiatives, is related to the priority areas of long term and late effects of cancer and its treatment. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No.017-001-00474-0) or "Healthy People 2000" (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 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. Teams of applicants representing a multi-disciplinary approach to the problem identified are encouraged. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign institutions are not eligible to apply for First Independent Research Support and Transition (FIRST) awards. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Research Project Grant (R01), the Small Grant (R03) and the FIRST (R29) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed 5 years. The small grant (R03) is limited to 2 years. The anticipated award date is July, 1998. 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. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. Except as otherwise stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health services Grant Policy Statement, DHHS Publication No. (OASH) 94-50,000 (REV.) April 1, 1994. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for awards under this RFA will be $3,000,000. Pending receipt of a sufficient number of applications of high scientific merit, the NCI intends to fund a total of approximately 12 to 15 awards in response to this RFA in FY98. Usual PHS policies governing grants administration and management related to the three mechanisms (R01, R03 and R29) will apply. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is contingent upon the continuing availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and the availability of funds. RESEARCH OBJECTIVES Background There are now approximately 10 million cancer survivors in the United States, 7 million of whom have survived for at least 5 years. SEER ( Surveillance , Epidemiology and End Results) data demonstrate improvements in the 5 year relative survival rates for melanoma, breast, uterine, prostate, testicular and bladder cancer, and for Hodgkin's Disease and non-Hodgkin's lymphoma, from 1974 - 76 to 1981 - 87 . There has been a decline in cancer mortality in the US from 1990 to 1995. Problems facing cancer survivors are multifaceted. They include physical, emotional and social stresses arising as a result of the effects of treatment, changes in lifestyle, disruption of home and family roles, and the fear of recurrence. Physical morbidity is an issue for the cancer survivor, as are psychologic and social morbidity. Cancer survivors often live with compromise, and face potential challenges arising as a result of changes in their strength and endurance, reproductive capacity, sexuality and body image . Cancer is a disease with both physical and psychosocial sequelae. Survivors have indicated that their concerns shift over time from illness related problems and towards societal and interpersonal issues. There is currently no consensus as to the defined needs of cancer survivors, or the long term physiologic and/or psychologic sequelae of the disease. Research into these areas is essential to delineate the long term health outcomes of cancer survivors. It is anticipated that new collaborative teams will be formed to address the issues that range from the biological/physiologic level to the psychosocial realm. The nature of the issues suggests a multi- disciplinary approach that will generate focused methods of assessment, provide impetus for research on quality of life, explore outcomes of different approaches to follow-up and surveillance of survivors as well as inquiries into the impact on family life, insurance and employment. Many late physiologic effects have been documented for survivors of childhood cancer. These include late effects from chemotherapy and irradiation, and the effects of multi-modal treatment including new primary cancers, impairment of cognitive, pulmonary, cardiac, hepatic, and gonadal function , and cosmetic changes. Reviews of the existing body of literature point to an increasing number of such physiologic effects. Areas that continue to be of particular importance to cancer survivors include: issues of quality of life and psychosocial adjustment beyond the acute period of treatment; reproduction and offspring; surveillance for the adverse sequelae of treatment and the development of new cancers; and the risk of recurrence. Knowledge of the human toll of having had, and being treated for, cancer measured in terms of quality of life, social outcomes related to jobs, insurance, social interactions is needed before interventions to lessen the negative impact or support the positive adjustment in an individual are proposed. RESEARCH GOALS The scope of this RFA is limited to long term survivors, defined here as at least five years from completion of primary cancer therapy and currently free of disease. This RFA requests applications that will provide the information about incidence and scope of effects of cancer and its treatment on survivors, their relationship to treatment, and where appropriate, proposals to test interventions, and the timing of interventions, to reduce the late morbidity of cancer and cancer therapy and to promote as normal a life as possible for the survivor. To achieve these purposes, a descriptive phase may be included to generate hypotheses about the intervention to be tested. It is suggested that the proposals will represent multi-disciplinary approaches and multiple end points where appropriate. SCOPE OF RESEARCH This initiative focuses on expanding our understanding of the physiologic and psychological issues related to cancer survivorship. Examples of some pertinent areas and research topics are listed below. This list is intended to be illustrative, not exhaustive. Topics are not presented in a priority order: o Prevalence and longitudinal incidence studies of physiologic late effects, e.g. cardiac toxicities and events, pulmonary compromise, late effects of limb sparing, minimal breast surgery and reconstructive surgery, ovarian failure, renal failure, and neurologic defects. o Prevalence and longitudinal incidence studies of psychosocial late effects, e.g. job and insurance discrimination, sexuality, quality of life, depression, cognitive function and mentation. o Prevalence and longitudinal studies of second cancers, including investigation of risk factors. o Reproductive function, e.g. fertility and health of offspring. o Economic impact, e.g. evaluation of effectiveness and cost of psychosocial and other interventions that will impact on survivorship outcomes. o Evaluation of the effectiveness of prevention interventions to prevent sequelae, e.g. cardioprotective agents, prevention of second cancers, maintenance of fertility, early interventions during treatment to lessen negative impact of sequelae. o Exploration of the impact of survivorship related to insurance and employment discrimination, including that related to the identification of high risk status, including genetic susceptibility. o Studies in offspring, e.g. birth defects, delayed developmental milestones and malformation rates. o Development and testing of diverse methodologic approaches specific to cancer survivors, e.g. instrument development, adaptation and validation of existing measures for use in special populations including culturally and ethnically diverse groups and the elderly. o Targeted prevalence studies of specific cancer related effects on survivors to determine the need for large scale studies. REQUIREMENTS In order for the purposes of the RFA to be accomplished, several requirements must be addressed: o The focus must be on long term survivors of cancer. This is not limited to persons who were diagnosed and treated as adults. Studies of long term survivors of childhood cancer are encouraged, as are studies of elderly survivors. o Attention must be paid to the use of appropriately valid and reliable measures of both physiologic and psychosocial variables. A short period of time at the start of the award can be dedicated to additional validation studies if needed. o The creations of a data base of the cohort that could be used to facilitate future studies should be considered. 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 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 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. LETTER OF INTENT Prospective applicants are asked to submit, by October 24, 1997, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and 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, the information that it contains allows staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Claudette G. Varricchio DSN, RN, FAAN Division of Cancer Prevention and Control National Cancer Institute 6130 Executive Boulevard, Room 300 Bethesda, MD 20892- 7340 Telephone: (301) 496-8541 FAX: (301) 496-8667 e-mail: varriccc@dcpcepn.nci.nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, Suite 6095, MSC 7910, Bethesda, MD 20892- 7910, telephone 301/435-0714, E-mail: ASKNIH@odrockm1.od.nih.gov; and from the program administrator listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 5/95) application form 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 title and number must be typed on line 2 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, photocopies, in one package 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 services) At the time of submission, two additional copies of the application must be sent to: Mrs. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Bethesda, MD 20892 Rockville, MD 20852 (for express/ courier service) Applications must be received by November 25, 1997. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA 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 substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the National Cancer Institute. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, DRG staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Cancer Institute in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. REVIEW CRITERIA The five criteria to be used in the evaluation of grant applications are listed below. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques 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 by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 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 method? 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? The initial review group will also examine: the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the provisions for the protection of human and animal subjects; and the safety of the research environment. AWARD CRITERIA Applications found to have significant and substantial merit will be considered for funding by the following: o priority score o availability of funds o programmatic priorities SCHEDULE Letter of Intent Receipt Date: October 24, 1997 Application Receipt Date: November 25, 1997 Review by National Cancer Advisory Board: May 1998 Anticipated Date of Award: July 1998 INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Claudette G. Varricchio DSN, RN, FAAN Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 300 Bethesda, MD 20892- 7340 Telephone: (301) 496-8541 FAX: (301) 496 8667 E-mail: varriccc@dcpcepn.nci.nih.gov Direct inquiries regarding fiscal matters to: Joy L. McCauley Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 6120 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 253 FAX: (301) 496-8601 E-mail: mccaulej@gab.nci.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399, CANCER control. 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 Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non- use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. 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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