Full Text CA-94-019 CANCER PREVENTION AND RURAL HEALTH NIH GUIDE, Volume 23, Number 19, May 20, 1994 RFA: CA-94-019 P.T. 34 Keywords: Cancer/Carcinogenesis 0730075 Disease Prevention+ Diagnosis, Medical National Cancer Institute Letter of Intent Receipt Date: June 20, 1994 Application Receipt Date: August 19, 1994 PURPOSE The Public Health Applications Research Branch, Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), invites research grant applications for research projects to develop, implement, and evaluate cancer prevention and early detection intervention strategies for rural populations. 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), Cancer Prevention and Rural Health, is related to the priority area of cancer. Potential applicants may obtain a copy of "Health 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 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, public and private, for-profit and non-profit, organizations such as universities, public health departments, voluntary organizations, research centers, hospitals, consortia of health providers, and units of state and local governments serving a substantial rural population. Collaborating applicant organizations and/or institutions with multidisciplinary expertise and access to rural populations are encouraged. Awards will not be made to foreign institutions and applicants from domestic organizations may not include international components. Applications from minority and women investigators are encouraged. MECHANISM OF SUPPORT Support of this program will be through the NIH individual research grant (R01). Applicants will be responsible for the planning, direction, and execution of the proposed project. However, it is anticipated that grantees funded under this RFA will meet regularly for purposes of sharing design and evaluation strategies, comparing results where possible, and distilling lessons learned from all grant projects. (See Special Requirements section.) The total project period for an application submitted in response to this RFA may not exceed four years. The anticipated award date is March 1995. This RFA is a one-time solicitation. Generally, future unsolicited competitive continuation applications will compete with all investigator-initiated applications and be reviewed by the Division of Research Grants (DRG). However, if the NCI determines that there is a sufficient continuing program need, a request for competitive continuation applications will be announced. Only recipients of awards under this RFA will be eligible to apply. FUNDS AVAILABLE Approximately $1,000,000 in total costs per year for up to four years will be committed to specifically fund applications that are submitted in response to this RFA. It is anticipated that three to five awards will be made and that the average annual direct costs will be $175,000 per award. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. The total project period for an application submitted in response to the present RFA may not exceed four years. The earliest feasible start-date for the initial awards will be March 1, 1995. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background The NCI is interested in stimulating research to develop effective methods for increasing cancer prevention and early detection services in rural populations and settings. Although rural residents are characterized by relatively low mortality rates, they experience higher rates of chronic disease, including cancer. The majority of elevated cancer mortality rates among rural versus urban residents are reversed with age, sex, and race adjustments for most cancers; however, some notable exceptions exist, such as lip and some skin cancers. In addition, there is evidence that cancer mortality among rural populations may be increasing more rapidly than increases among urban populations. Rural cancer patients are reportedly diagnosed at later stages of disease, have higher proportions of unstaged cancers at diagnosis, and are at more advanced stages of illness when referred to home health care agencies. Cancer prevention and early detection practices in rural settings appear to lag behind urban settings. Smoking rates appear to be dropping more slowly in predominately rural states and use of breast and cervical cancer screening is reported to be lower in rural compared to urban settings. A number of studies indicate that rural residents receive fewer cancer services than their urban counterparts, that rural residents utilize telephone cancer information services less frequently than urban residents, and that rural communities have fewer cancer prevention activities than urban communities. Rural communities differ from urban communities in other important ways. Rural residents tend to have lower income, higher poverty, less education, greater adherence to traditional gender roles and longer periods of public assistance than urban residents. Rural residents have fewer choices about where and from whom they will receive health care: almost one-half of the resources for rural health comes from Federal sources, fewer specialized services are available in rural settings and rural hospitals are closing at an alarming rate. In addition, rural residents are limited by lack of public transportation and poorer roads, they are more physically isolated than urban counterparts and they have been characterized by a tradition of individualism, self-sufficiency and community and family orientations. Major reductions in U.S. cancer mortality and morbidity are believed to be dependent on the widespread adoption of cancer prevention behaviors and use of early detection services; this includes rural populations. Unfortunately, relatively little research has been published on effective intervention strategies for meeting the unique needs of rural populations. This RFA is intended to address this problem. Research Goals and Scope The primary goal of this project is to develop, implement, and evaluate cancer prevention and early detection intervention strategies for rural populations and settings. Definition of Rural - For purposes of this procurement, rural refers to areas of low population size and density that are categorized as (1) nonmetropolitan, using the designation of Metropolitan Statistical Areas by the U.S. Office of Management and Budget (OMB) or (2) rural, using the definition formulated by the U.S. Bureau of the Census (RHRP 1991). Intervention Approaches - Investigators are encouraged to submit applications that focus on the prevention and/or screening and early detection of cancer. Research projects should address the cancer concerns of special relevance to rural populations. For example, cancer prevention research projects might address protection from lip and skin cancer, tobacco use reduction, diet and nutrition modification, or control of pesticides and other occupational/environmental carcinogens. Cancer screening and early detection research projects might address the frequency and/or quality of clinical breast exams and mammography screening for the early detection of breast cancer, pap smears for the early detection of cervical cancer and/or rectal exams and proctosigmoidoscopy for the early detection of colon cancer. Appropriate behavioral, educational and/or organizational scientific theories should provide the foundation for identification of barriers to cancer prevention and control in rural populations and settings, design of appropriate intervention approaches and evaluation of intervention outcomes. Interventions may be targeted to individuals within rural communities, health care providers serving rural communities, public health structures, community organizations, or other appropriate individuals and/or groups. Interventions may address individual, community and/or organizational level barriers to effective cancer prevention and control. Consideration must be given to the specific demographic, socioeconomic, cultural, and geographic factors that affect rural health-related behaviors and health provider practices. Examples of interventions focusing on health-related prevention and early detection behaviors in rural populations might include increasing social support for early detection practices, providing transportation and/or enhancing availability and value judgements of services, conducting education campaigns that build upon rural values and consider sociodemographic characteristics, providing incentives for maintenance of screening behaviors, and/or stimulating policies that reduce cost barriers. These interventions might involve women's groups, fraternal organizations, youth clubs, churches, unions, worksites, and local business such as grocery stores or beauty parlors, and other community-based organizations. Examples of interventions seeking to increase cancer prevention and early detection behaviors by targeting health care providers and systems of health services delivery in rural settings might include developing training modules in conjunction with rural health training centers such as rural Area Health Education Centers (AHECs), providing training to health care providers and allied health professionals in delivering cancer risk information to minimize anxiety and motivate adherence to cancer prevention and early detection guidelines, developing office systems to enhance delivery of services, developing approaches to modify referral patterns and followup procedures especially for specialized services, assisting patients navigate the health system including for example completion of billing and insurance forms, and developing communications strategies and materials tailored to patient characteristics and beliefs, such a limited literacy skills and misconceptions about cancer cure and treatment. Evaluation - Evaluation of the effectiveness of interventions to improve the health status of rural residents is a critical component of this RFA. An adequate design must be employed to reliably demonstrate the effectiveness of interventions in reaching the target population and affecting cancer prevention and control practices. Baseline information must be obtained, including assessment of population demographics, health status, current knowledge, attitudes, beliefs and practices, health service utilization patterns, etc. as appropriate to the study questions. Randomization of the target population to intervention and nonintervention groups is the preferred study design, although other well justified study designs with appropriate comparisons, such as multiple time series designs, will be considered. Stratification into specific groups (e.g., occupation, income, education, marital status, geographic setting, etc.) also may be appropriate to address special research questions of particular importance in rural populations and settings. However, comparison groups must be of sufficient size to provide the statistical power needed to detect significant differences and appropriate power calculations should be provided. Plans for statistical analyses should be described in detail adequate to evaluate the potential for success of the application research plan. Final outcome measures should reflect improvements in health status and/or health-related behaviors, and may include for example, changes in stage at diagnosis, proportion of unstaged cases at diagnosis, number of preventive care visits, number and frequency of screening tests performed, compliance with screening guidelines, case fatality, time from diagnosis to treatment. Interim measures such as improvements in knowledge, attitudes, beliefs and/or intentions may be included if relevant to the intervention being tested. Applications must include a clear plan for process evaluation. Process evaluation should provide information about implementation of the intervention and factors that both positively and negatively influenced implementation and any changes to the intervention as it was being implemented. Process information should be used to facilitate intervention design and implementation as well as interpretation of outcome results. High priority will be given to research projects that are applicable to rural communities nationwide and that can be easily replicated and disseminated. Successful interventions developed through this research will be used to assist health professionals working in rural areas around the country to address cancer prevention and early detection needs. Research results will be disseminated through appropriate NCI programs such as the Appalachia Leadership Initiative on Cancer (ALIC), the Cancer Information Service (CIS), the Cancer Centers, and the Community Clinical Oncology Programs (CCOPs). SPECIAL REQUIREMENTS As stated under MECHANISM OF SUPPORT, grantees may be expected to collaborate on research and project reporting strategies and to share project progress and experiences. Thus, each grantee may include in her/his budget funds for at least two investigators to attend two meetings per year in Rockville, MD with fellow grantees. Investigators will be expected to supply a final report in a specific format, which summarizes both successes and failures in order to contribute to the dissemination of community intervention research. In addition, grantees may be expected to participate in a joint summary of results of all grants. STUDY POPULATIONS 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 Population) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was reprinted in the Federal Register of March 28, 1994 (59 FR 14508-14513) to correct typesetting errors in the earlier publication, and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by June 20, 1994, a letter of intent that includes a descriptive title of the proposed research, the name and address of the Principal Investigator, the names of other key personnel, the participating institutions, and the number and title of the RFA in response to which an application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the final review of subsequent applications, the information it contains is helpful in planning for the review of applications. It allows NCI staff to estimate the potential review workload and to avoid possible conflict of interest in review. The letter of intent is to be sent to Dr. Marianne Haenlein Alciati 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. These forms are 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). The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page of the applications. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee on time for review. In addition, the RFA number and title should be typed on line 2a 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, exact, clear and single-sided photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636A 6130 Executive Boulevard Rockville, MD 20852 (If hand-delivered or delivery service) Bethesda, MD 20892 (If using US Postal Service) It is important to send these copies at the same time that the original and three copies are sent to DRG, otherwise, the NCI cannot guarantee that the applications will be reviewed in competition with other applications received by the designated receipt date. Applications must be received by August 19, 1994. If an application is received after that date, it will be returned. The DRG will not accept any application in response to this RFA that is 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 by DRG for completeness and for responsiveness by NCI. Incomplete applications will be returned to the application without further consideration. If the applicant is not responsive to the RFA, NCI program staff will 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 may receive a preliminary scientific peer review (triage) by an NCI peer review group on the basis of relative competitiveness. The NCI will remove from further competition those applications judged to be non-competitive for award and notify the applicant principal investigator and institutional official. Those applications that are competitive will be evaluated in accordance with criteria stated below for scientific/technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review will be provided by the National Cancer Advisory Board. The review group will assess the scientific merit of the studies according to the following criteria: o The extent to which the application demonstrates an understanding of the barriers to cancer control in rural populations and settings; o Rationale for and appropriateness of the selected intervention approach; consideration of appropriate behavioral, educational and/or organizational scientific theories in intervention selection and development; consideration of sociodemographic, cultural, economic factors and cancer control needs in intervention selections and development; o Scientific/technical merit, adequacy, appropriateness, and feasibility of the evaluation plan including consideration of methodologic, measurement/instrumentation, sample size and power considerations; sufficient detail in description of methods or procedures; and sufficient allocation of resources; o Understanding of the selected rural population, particularly in terms of health factors such as the current status of access to and utilization of health care services, knowledge, attitudes, beliefs and behavior relevant to cancer prevention and control and cancer control needs as well as other economic, cultural and sociodemographic factors that might influence cancer prevention and control initiatives; o Adequacy and soundness of the staffing and project management plans, including the overall balance of necessary disciplines and expertise in relation to the objectives of the research project; evidence of the capability, experience and qualifications of the principal investigator and other investigators as well as cooperating institution's technical staffs to implement the project successfully; and adequacy of time (effort) which the principal investigator and other investigators, if any, would devote to the proposed studies; o Feasibility of the project within the resources and timeframes proposed; appropriateness of the proposed budget and duration in relation to the proposed initiative; and inclusion of specific written agreements with cooperating institutions, including those agencies that may be providing services and/or the settings for these services. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each approved application. AWARD CRITERIA NCI staff will take into account demographic and geographic distribution of peer-reviewed and approved applications, the availability of funds, and priority scores in the final selection process. Several applications approved for funding and studying the same rural population will be considered, but may not be awarded. INQUIRIES Written and telephone 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: Marianne Haenlein Alciati, Ph.D. Public Health Agency Section National Cancer Institute Executive Plaza North, Room 233 Bethesda, MD 20892 Telephone: (301) 496-8584 Direct inquiries regarding fiscal matters to: Robert E. Hawkins Grants Administration Branch National Cancer Institute Executive Plaza South, Room 242 Bethesda, MD 20892-4200 Telephone: (301) 496-7800, ext. 213 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 HHS 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 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. .
Return to NIH Guide Main Index
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
||||||||
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files. |