This Program Announcement expires on October 2, 2003, unless reissued. EXPLORATORY GRANTS FOR BEHAVIORAL RESEARCH IN CANCER CONTROL Release Date: October 1, 2001 PA NUMBER: PA-02-001 (see replacement PA-04-034) National Cancer Institute THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER YEAR. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html. This Program Announcement (PA) replaces PA-99-163, which was published in the NIH Guide on September 7, 1999. PURPOSE The Division of Cancer Control and Population Sciences and the Division of Cancer Prevention of the National Cancer Institute (NCI) invite research grant applications from interested investigators to conduct developmental and formative behavioral research in cancer prevention and control through a program of exploratory investigator-initiated R21 grants. The exploratory/developmental (R21) grant mechanism is used for pilot projects or feasibility studies to support creative, novel, research that aims to produce innovative advances in science. The objective of this Program Announcement (PA) is to encourage applications from individuals who are interested in research in the behavioral aspects of the cancer control continuum from prevention to end of life care. RESEARCH OBJECTIVES Background The NCI supports behavioral research and other intervention studies related to cancer prevention and control through research project grants. Historically, this research has emphasized evaluation of health behavior interventions or disease outcomes, rather than the fundamental mechanisms of cancer-related behaviors or pre-intervention research. With the exception of Small Research Grants (R03), primarily targeted to new or previously unfunded cancer prevention and control investigators, it has been difficult for behavioral scientists to obtain funding for hypothesis development, methods or measurement development, new intervention approaches, or feasibility studies. It is expected that these R21 grants will serve as a basis for planning future behavioral and cancer control intervention research project grant applications (R01). This PA, therefore, is intended to stimulate developmental and exploratory approaches to primary and secondary cancer prevention, prevention of cancer-associated morbidity, quality of life, rehabilitation, and health promotion behavioral research through a program of exploratory investigator-initiated R21 grants. Because the exploratory grant mechanism is designed to support innovative ideas, preliminary data as evidence of feasibility are NOT required. The applicant does have the responsibility for developing a sound research plan with a strong theoretical or empirical basis. Originality of the approach and potential significance of the proposed research are major considerations in the evaluation. Research Goals and Scope The major goal of this initiative is to promote timely and innovative behavioral, clinical, and culturally appropriate research approaches in cancer prevention and control. Studies may focus on: 1) Assessment (instrumentation methods, measurement development), 2) Intervention (feasibility of new and innovative approaches, appropriateness for use in populations disproportionately burdened with cancer, or other clinical, organizational and community settings, 3) Dissemination (applications, sustainability), 4) Surveillance (issues of inclusion of minority populations, data base linkage studies to monitor progress toward cancer prevention and control), and 5) psychological influences on cancer and the biobehavioral mechanisms underlying cancer related behaviors. This R21exploratory/developmental award mechanism is appropriate for testing timely interventions in pilot studies for feasibility or using rigorous qualitative research methods to assess efficacy of an intervention. It is also appropriate for the psychometric evaluation of new measures or culturally appropriate ones to be adapted for use in populations for whom measures have not been developed or validated. Research Issues Examples of priority areas for exploratory approaches to behavioral research in cancer prevention and control which might need development or pilot work and could be addressed by applicants are listed below. The list is illustrative rather than comprehensive. It is expected that additional relevant and important research topics will be identified by investigators responding to this announcement. Therefore, applicants are strongly encouraged to discuss their ideas with NCI program staff. 1. Enhancing Risk Communication, Comprehension, and Informed Decision-Making Under Uncertainty: As new technologies are integrated into mainstream medical care, patients are being challenged to make difficult decisions in the face of uncertain risks and benefits. Genetic testing is one example of this. Valid and reliable methods to evaluate strategies to improve cancer risk communication, enhance comprehension, and facilitate informed decision-making about options for cancer prevention, screening and treatment are required. These must be explored and evidence of efficacy made available to address appropriate methodology and research questions for intervention studies in the future. 2. Integrating Preventive and Early Detection Services into Changing Health Delivery Systems: The proportion of the insured population covered by a managed care arrangement has increased, and continues to rise steadily. Increasingly, primary care providers, and physicians in particular, are becoming part of larger organizations. Over three-fourths of physicians now participate in managed care. Behavioral research must respond to this change in health care delivery by designing and testing innovative cancer prevention and control interventions that can be integrated into health care systems in a cost-effective manner. Appropriate methodology must be developed and tested before doing this type of research. 3. Enhancing Survivorship of Cancer Patients: Due to advancements in early detection and treatment, people are living longer with cancer, dramatically increasing the number of cancer- affected life-years in our nation. There are now over eight million cancer survivors in the U.S. This raises the question of the quality of that extended survival time, including its effect upon productivity, family functioning, and both medical and psychiatric comorbidity. New behavioral and psychosocial interventions targeted to this population are needed to enhance functional health status (e.g., return to work), improve coping and adjustment to the effects of cancer and its treatment, improve the delivery of palliative and end of life care, and promote health behaviors that may reduce the risk of second malignancies. Instrument development, observational studies, and innovative approaches for this population are needed before research can proceed. 4. Promoting a Healthy Diet and Physical Activity: Nutrition and physical activity play an important role in the initiation, promotion, and progression of cancer. U.S. guidelines recommend diets that are low in fat and high in fiber, fruits, and vegetables. Yet, only a small proportion of the U.S. population adheres to recommended guidelines for diet or participates in regular physical activity. Robust methods must be developed to examine and explain the determinants of changes in these behaviors. Relatively little research has been published on key theoretical measures of constructs such as self-efficacy or perceived barriers when applied to fruit and vegetable consumption. Little is known about measures appropriate for minority, low- literacy or high-risk populations. Innovative intervention designs must be assessed for feasibility and cultural competence before they can be targeted to populations at high risk for cancer. 5. Prevention, Treatment and Control of Tobacco Use among Children, Teenagers, and Adults: Innovative methods are needed to identify determinants of smoking initiation and maintenance in U.S. children and teenagers, including high risk groups. Psychometric validation of new measures may be necessary before these are applied in larger studies. Innovative strategies, with potential for broad public health application, to reduce prevalence among these population groups need to be designed. These methods and strategies must be tested for feasibility and efficacy in different settings. 6. Improving the Outcomes of Genetic Testing for Cancer Susceptibility: Breakthroughs in cancer genetics have created unprecedented opportunities for individuals to learn whether they carry mutations in cancer-predisposing genes. Genetic information has potentially far-reaching consequences for the psychological well-being and medical care of individuals at high risk for cancer. A better understanding of the behavioral and sociocultural impact of disclosure of genetic information is critical to designing optimal education and counseling approaches. Innovative, process-oriented research that incorporates contemporary theories and methods from the social and behavioral sciences is needed. 7. Prevention of Cancer: Behavioral interventions to promote adherence chemo-prevention interventions need to be developed and tested. The longitudinal nature of cancer prevention trials requires adherence to the activity or agent over a time frame of many years. The determinants of adherence may be different for specific sub-groups of the population. Evaluation of different approaches to ensure adherence to the prevention protocol and to understand the determinants of non-adherence are appropriate for this mechanism of support. 8. Prevention of Cancer Associated Morbidity: A limiting factor in successful cancer therapy is often dose related toxicity or disease related symptoms. The development and validation of assessment measures for use in specific sub populations or the development of new measures to assess the outcome of interventions to limit disease related symptoms is encouraged, as is pilot testing of the behavioral component of such interventions. Cross-Cutting Themes The following are relevant to all areas of priority behavioral research, and therefore, are strongly encouraged as cross-cutting themes to be considered in applications prepared in response to this Program Announcement. 1. Consideration of Ethnicity, Social Class, and Culture: The development and testing of interventions with valid and reliable measurement tools that are practical and culturally competent are needed. Since little is known about the relative importance of sociocultural, economic, educational and other behavioral factors to the differential burden of cancer in the United States, special efforts are required to identify and reduce the risk, incidence and mortality of cancer among population subgroups. In addition, we need to examine both system-wide as well as individual and group barriers to screening, medical treatment and adherence, and end of life care. 2. Underserved Populations: Researchers are encouraged to extend behavioral theories to underserved populations, as well as develop new theories. In addition, this PA encourages theory-based studies designed to test the active ingredients in interventions: what makes them work? What makes them transferable to other populations or inhibits their dissemination? 3. Methods and Measurement: Innovative methods, measurement and analysis techniques are a critical need within many domains within the behavioral and social sciences, and are needed to provide a solid foundation on which to develop new intervention methodologies (e.g., with populations in whom interventions have not previously been effective). Such research is essential to improve the reach and effectiveness of interventions, particularly for underserved populations and those at disproportionate risk for cancer. Research to develop, modify and validate questionnaires for use in minority populations is a priority for the National Cancer Institute. Qualitative research methods have potential value for understanding the complexity of health behaviors. In addition, with the development of new intervention approaches, study designs and statistical analyses must extend from individual analysis to multiple levels of intervention impact, such as communities. Understanding the success or failure of these interventions will also depend on the ability to study the mechanisms of intervention impact and dissemination, using validated assessments of the processes of behavior change. 4. Research Settings: Behavioral research initiatives may focus on any or all phases of the cancer control continuum, from prevention, detection, diagnosis and treatment, through survivorship, and end of life issues. Research activities may take place in a variety of settings. Exploratory studies of novel approaches targeted at specific research settings are encouraged. For example, little is known about environmental factors that affect fruits and vegetable consumption, and research settings could include worksite caterers, schools, vending machines, stores and restaurants, further work is need on nutritive approaches that improve quality of life for cancer survivors. 5. Surveillance of Cancer Related Behaviors: New approaches to health services research and information data base linkage are needed to monitor cancer related behaviors, particularly in rural populations, ethnic/minority groups and low socioeconomic groups. Innovative approaches that address surveillance problems using newly available data and modern statistical methods (e.g., analytical methods employing GIS, microsimulation or variance estimation for age-adjusted rate trends) are strongly encouraged. Summary Research funded through this R21 mechanism is expected to increase scientific knowledge about health behaviors and health care practitioners" behaviors in a number of areas. These areas include but are not limited to: tobacco cessation, sun exposure, cancer screening behaviors, diet, weight and physical activity factors relevant to in cancer risk reduction and treatment, communication patterns and technologies between health care practitioners and patients, cancer survivorship issues, socio-cultural factors in health behaviors and in health care practitioner behaviors, and basic bio-behavioral factors. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) exploratory/developmental (R21) grant mechanism. 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 PA may not exceed TWO years. These grants are non- renewable and continuation of projects developed under this PA will be through the traditional unsolicited investigator initiated grant program. The earliest anticipated award date is December, 2002. Applicants may request up to $100,000 direct costs (four budget modules). Though the size of the award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the NIH. Complete and detailed instructions and information on Modular Grant applications have been incorporated into the PHS 398 (rev. 5/2001). Additional information on Modular Grants can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. 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. Faith-based organizations are eligible to apply for these grants. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Sabra F. Woolley, Ph.D. Division of Cancer Control and Population Sciences National Cancer Institute Executive Plaza North, Room 4078, MSC 7335 Bethesda, MD 20892-7335 Telephone: (301) 435-4589 FAX: (301) 480-2087 Email: sw215x@nih.gov Clarification of topics 7 and 8 under the Research Issues section listed above should be directed to: Claudette Varricchio, D.S.N. Division of Cancer Prevention National Cancer Institute Executive Plaza North, Room 300, MSC 7340 Bethesda, MD 20892-7340 Telephone: (301) 496-8641 Email: cv9h@nih.gov Direct inquiries regarding fiscal matters to: Crystal Wolfrey Grants Administration Branch National Cancer Institute 6120 Executive Blvd., Suite 243 Bethesda, MD 20892 (for regular mail) Rockville, MD 20852 (for hand-delivered mail) Telephone: (301) 496-8634 FAX: (301) 496-8601 Email: crystal.wolfrey@nih.gov APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in applying for these grants and will be accepted at the standard application deadlines (http://grants.nih.gov/grants/dates.htm) as indicated in the application kit. This version of the PHS 398 is available in an interactive, searchable PDF format. Although applicants are encouraged to begin using the 5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to accept applications prepared using the 4/1998 revision until January 9, 2002. Beginning January 10, 2002, however, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact the Institute or Center (IC) program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the IC staff that the IC will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute or Center who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of the original application as well as any subsequent revisions. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-030.html. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and NIH staff. The research grant application form PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. Applicants are permitted, however, to use the 4/1998 revision of the PHS 398 for scheduled application receipt dates until January 9, 2002. If you are preparing an application using the 4/1998 version, please refer to the step-by-step instructions for Modular Grants available at http://grants.nih.gov/grants/funding/modular/modular.htm. Additional information about Modular Grants is also available on this site. The title and number of the PA 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 five signed, exact, single-sided photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned based on established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific 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 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: o the appropriateness of proposed project budget and duration, o the adequacy of plans to include both genders, minorities (and their subgroups), and children as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, o the provisions for the protection of human subjects, o the safety of the research environment, o the adequacy of the proposed plan to share data. AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities. 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 sub- populations 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 indicating 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 UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups, if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS. It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are clear and compelling scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects, published in the NIH Guide for Grants and Contracts on March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. 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. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS All investigators proposing research involving human subjects should read the NIH policy on education in the protection of human research participants now required for all investigators, which is published in the NIH Guide for Grants and Contracts, June 5, 2000 (Revised August 25, 2000), available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. A continuing education program in the protection of human participants in research is now available online at http://cme.nci.nih.gov/. All clinical trials supported or performed by NCI require some form of monitoring. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NCI program staff to a Data and Safety Monitoring Board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB). For details about the Policy of the NCI for Data Safety Monitoring of Clinical Trials see http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For Phase I and II clinical trials, investigators must submit a general description of the data and safety monitoring plan as part of the research application. See NIH Guide Notice on Further Guidance on a Data and Safety Monitoring for Phase I and II Trials for additional information: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. Information concerning essential elements of data safety monitoring plans for clinical trials funded by the NCI is available to http://www.nci.nih.gov/clinicaltrials/conducting/dsm-guidelines. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-004.html). HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS- led national activity for setting priority areas. This PA, Exploratory Grants for Behavioral Research in Cancer Control, is related to priority area of Cancer Control. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399. Awards are made under authorization of the Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH 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 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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