CANCER SURVIVORSHIP STUDIES IN ESTABLISHED EPIDEMIOLOGIC COHORTS Release Date: February 18, 1998 PA NUMBER: PA-98-027 P.T. National Cancer Institute PURPOSE The Division of Cancer Control and Population Sciences (DCCPS) of the National Cancer Institute (NCI) invites investigator-initiated grant applications (R01s) and applications for competing supplements to existing NIH-funded research project grants (R01s, P01s) or cooperative agreements (U01s) for innovative, interdisciplinary research using existing epidemiologic study populations to address issues related to long-term survivorship of cancer, particularly in the areas of specific health or lifestyle outcomes and their modulation by common risk factors or other exposures. During the past decades, the National Cancer Institute and other Institutes and Centers at NIH have sponsored many epidemiologic studies which now present special opportunities for research in long-term cancer survivorship. Since many of these studies were implemented, new methodology has been developed for computerized linkage to augment original data sets and for follow-up of study participants, and advances in cellular biology have made it possible to evaluate risk and prognostic factors at the molecular level and to more accurately identify precursors of invasive disease. This initiative seeks to build on existing resources from previous epidemiologic studies through the application of these new technologies, to enhance knowledge and understanding of long-term cancer survivorship. 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), "Cancer Survivorship Studies in Established Epidemiological Cohorts," 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 Stock No. 017-001-10473-1) 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 or local government, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT The mechanism of support will be the individual research project grant (R01) and competing supplements to existing NIH-funded research project grants and cooperative agreements. R01 applications may be based on cohorts from grants or cooperative agreements previously funded by NCI or other Institutes and Centers at NIH. Applications may be submitted for competing supplements to ongoing grants or cooperative agreements supported by NCI or other Institutes and Centers at NIH for innovative, interdisciplinary research using existing epidemiologic study populations to address issues related to long-term survivorship of cancer, particularly in the areas of specific health or lifestyle outcomes and their modulation by common risk factors or other exposures. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total requested project period for an application submitted in response to this PA may not exceed five years. Competing supplements may not extend beyond the funding period of the parent grant; the parent grant must have at least one year remaining in its project period after award of the supplement. RESEARCH OBJECTIVES Background Scientific advances in cancer prevention, early detection, and treatment have changed the course of cancer from an acute terminal illness to a more chronic disease process which, for many, includes prolonged remission or cure. Currently in the United States, there are over 10 million persons who have survived a diagnosis of cancer; approximately 8 million of whom have survived five or more years. However, despite the broad impact of survivorship throughout the lives of patients and their families and caregivers, relatively little research has been directed at problems of survivorship beyond the immediate post-treatment phase. The NCI Office of Cancer Survivorship was established in 1996 to articulate the opportunities and challenges of survivorship research and to provide a focus for programmatic research to address questions posed by the scientific and survivor communities. The Office held a meeting on "Unresolved Issues in Cancer Survivorship" in November 1996 at which panels of researchers and survivors explored the need for research in areas including quality of life, physiologic outcomes, reproduction and sexuality, second malignancies, and economic impact of cancer survival. Conference participants concluded that current support for research dealing with issues of concern to survivors is inadequate and that additional research directed toward outcomes is necessary to determine appropriate long-term medical care and psychosocial needs and to identify interventions which are likely to improve the quality of life for long-term survivors. Participants recognized the importance of considering risk factors for second cancers and other chronic diseases in health outcomes and, for all areas of study, encouraged the use of existing data resources for cohort identification. During the past decades, the National Cancer Institute has sponsored many epidemiologic studies in cancer etiology and epidemiology which now present special opportunities for research in long-term survivorship. Utilization of these existing study populations for survivorship research by prospective or historical follow-up of the original study participants offers unique advantages in study design and implementation: --Cancer cases and controls have already been identified, diagnoses have been confirmed, and an initial contact has been established with each participant as part of the original study. --Risk factor and exposure information has been collected as part of the original study, so that these data are complete and are available even for participants who are now deceased. --The existence of cohorts established at the time of cancer diagnosis allows description of the survivorship experience over time, including an overview of who survives and which characteristics contribute to survival and other outcomes. --The existence of an established control group allows direct comparisons of risk factors, exposure data, and outcomes. --For selected studies, serum banks or specimen repositories may allow inclusion of physiologic or molecular variables as covariates, or of changes in physiologic function as outcome variables. Additional advantages include the ability to : Incorporate recently adopted epidemiologic techniques. New methods for tracking individual participants (e.g., credit bureau locators), computerized matching and merging records from diverse sources (e.g., cancer registry data, vital statistics files, health care billing codes), and new approaches to ascertainment of health outcomes (e.g., quality of life/health status measures, comorbidity scores) may provide additional dimensions to traditional approaches for participant follow-up and outcomes assessment. Include newly recognized molecular markers for risk factors and disease outcomes. The use of molecular markers for disease predisposition and/or diagnosis of preneoplastic changes, and consideration of genetic polymorphisms which potentially modulate exposure effects, allow exploration of interactions between genetic and environmental risk factors. Promote collaboration between epidemiologists and clinicians experienced in survivorship research. This approach links expertise from scientific backgrounds in cancer epidemiology and clinical oncology, assuring optimal use of existing and new data bases for study purposes. While prospective studies of patients currently completing cancer therapy can eventually provide detailed information on survivorship issues, particularly about physiologic outcomes and quality of life, late events associated with survivorship may not be recognized for many years. There is an immediate need for information about health consequences late in the survivorship experience, to assure appropriately targeted surveillance and quality medical care for long term-survivors and to enable them to achieve and maintain the highest possible quality of life. Building survivorship research on a foundation of existing and relevant resources such as established epidemiologic cohorts and case-control study populations provides the opportunity to expand our knowledge and understanding of long-term problems of survivorship in a timely and efficient manner and enhances our understanding of survival determinants in the context of documented etiologic/risk factors. Research Scope and Goals This goal of this PA is to foster effective and efficient research in issues related to long-term cancer survivorship through the use of existing epidemiologic study populations, particularly in the areas of specific health or lifestyle outcomes (e.g., general health outcomes, reproductive patterns, second cancers, comorbid diseases) and their modulation by common risk factors and other exposures. Its major objective is to expand the scope of existing epidemiologic data sets to more comprehensively address survivorship issues through the use of innovative epidemiologic and molecular approaches. The PA requests R01 applications and competing supplements to existing grants or cooperative agreements for survivorship research which are based on established epidemiologic study populations from NIH-supported research projects. In contrast to RFA CA-97-018 "Long-Term Cancer Survivors: Research Initiatives," this PA encourages applications exploring differences between cancer survivors and non-survivors that may be linked to mechanisms of disease development or progression, including genetic predisposition and modulating factors. The original project may be a retrospective epidemiologic study (e.g., case- control study of etiologic or risk factors) or a prospective study or demonstration project in which incident cancer cases have been identified. For either approach, the number of cases and duration of potential follow-up must be sufficient to provide a clear picture of the survivorship experience from time of diagnosis and to address specific questions about late effects and long-term consequences in cases surviving more than two years from completion of therapy. Applications should address specific issues in any of the following areas: 1) Physiologic function and/or medical diagnoses, including but not limited to: competing causes of mortality; comorbid medical conditions, modulation of medical outcomes by epidemiologic or molecular risk factors. 2) Reproduction and sexuality, including but not limited to: post-treatment fertility, complications of pregnancy, occurrence and consequences of early menopause, medical/surgical interventions for sexual dysfunction. 3) Second cancers, including premalignant and predisposing conditions. 4) Other areas: psychosocial issues (including quality of life); career, employment, and economic impact. To address these questions, investigators are encouraged to use innovative and efficient approaches toward augmenting original study data and collecting cancer treatment information and follow-up. These may include: 1) To provide follow-up and/or expand outcome information on participants in the parent study; 2) To add new data variables (e.g., risk factors, confounding variables, prognostic indicators, outcome variables) by computerized data linkage with other information systems; 3) To incorporate routinely-collected clinical data not usually considered in survivorship studies (e.g., performance status scores, physiologic measurements during treatment); and 4) For projects with existing tissue or serum banks, or for cancer cohorts with tissue blocks from primary cancer diagnosis (and/or second cancer diagnosis, as applicable), to include molecular variables as indicators of exposure, physiologic risk factors, or prognostic indicators. Whenever possible, study designs should incorporate risk factor and other epidemiologic information from the original study as secondary study hypotheses or as potential confounders of primary study questions. Investigators are also encouraged to integrate methodologic approaches from social science research and health services research to address diverse, non- medical outcomes and to include collaborators and consultants with experience in these areas on the investigative team. Expertise in other medical/surgical subspecialties, rehabilitation medicine, psychosocial sciences, outcomes assessment, medical informatics and data management, and statistical analysis should be included in the study team as needed. Applications submitted in response to the Program Announcement should represent collaborative efforts between investigators skilled in clinical and/or preventive oncology and colleagues with expertise in cancer epidemiology. R01 applications based on completed epidemiologic studies should, if possible, include the Principal Investigator of the original epidemiologic studies as a collaborator in the proposed research. If the Principal Investigator of the original study is not included in the research team, assurance of access to the original study population, epidemiologic data, and repository specimens must be provided. 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 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). 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, Vol. 23, No. 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 the grant application form PHS 398 (rev. 9/95) 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 Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-435-0714, E-mail: ASKNIH@od.nih.gov. The title and number of the program announcement must be typed in Item 2 on the face page of the application and the "YES" box marked. The completed original application and five legible copies must be sent or delivered to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD, 20817 (for courier/overnight 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 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 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 the study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effects 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? 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 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 will compete for available funds. 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, particularly during the planning phase of the grant applications. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Susan G. Nayfield Division of Cancer Control and Population Sciences National Cancer Institute 6130 Executive Boulevard, Suite 535, MSC 7395 Bethesda, MD 20892-7395 Telephone: (301) 594-7344 FAX: (301) 435-5477 Email: nayfiels@epndce.nci.nih.gov Direct inquiries regarding fiscal matters to: Mr. Bill Wells Grants Administration Branch National Cancer Institute Executive Plaza South 6120 Executive Boulevard, Suite 243, MSC 7150 Bethesda, MD 20892-7150 Telephone: (301) 496-7800, EXT. 250 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.393 and No. 93.856. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-140, as amended by Public Law 99.158, 42 USC 241 and 285) and administered under DHHS policies and grant regulations. 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. 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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