CENTERS OF EXCELLENCE IN CANCER COMMUNICATIONS RESEARCH Release Date: February 5, 2001 RFA: RFA-CA-01-019 (see replacement RFA-CA-03-007) National Cancer Institute Letter of Intent Receipt Date: June 14, 2001 Application Receipt Date: July 11, 2001 PURPOSE This initiative is the centerpiece of the National Cancer Institute’s (NCI) Extraordinary Opportunity in Cancer Communications. The novelty and scope of this initiative reflects the NCI’s recognition that effective communications can and should be used to narrow the enormous gap between discovery and applications and to reduce health disparities among our citizens. The RFA uses the P50 centers award mechanism to invite applications for Centers of Excellence in Cancer Communications Research (CECCRs). The Centers must include three or more individual hypothesis-driven research projects, pilot or developmental research projects, shared resources and a plan for career development. To be effective, the Centers research should integrate cancer communications appropriately into one or more contexts of the cancer continuum--from prevention through treatment to survivorship and end-of-life research. Communications research also is needed about challenging topics such as cancer information seeking, decision making under uncertainty, and genetic testing. Centers research also should provide insight into mechanisms underlying how people process information. It is expected that the Centers interdisciplinary efforts will result in new and/or improved syntheses, theories, methods and interventions, including those for diverse populations. The centers will provide essential infrastructure to facilitate rapid advances in knowledge about cancer communications, translate theory and programs into practice, and train health communication scientists. Potential applicants are encouraged to consult the NCI’s Bypass Budget (http://plan2002.cancer.gov) for background about the NCI’s goals and progress in cancer communications. RESEARCH OBJECTIVES Background Healthy People 2010 defines health communication as the research-based crafting and delivery of messages and strategies to promote the health of individuals and communities. Communication is central to quality cancer care, from primary prevention to survivorship (Institute of Medicine (IOM), 1999). http://www.iom.edu There is a substantial literature that shows communication interventions can raise awareness of health problems and recommended actions, give people the information they need to make informed cancer-related decisions and motivate action (e.g., AHRQ, 2000, Skinner et al., 1999, O Connor et al., 1999, Science Panel on Interactive Communication and Health, 1999). The framers of the National Cancer Act of 1971 (and the subsequent amendments to that Act) were acutely aware of the central importance of cancer communication. Thus, they mandated that the National Cancer Institute (NCI) provide a program to disseminate scientific and other information regarding the causes, prevention, detection and treatment of cancer. Pursuant to this mandate, and mindful of the dramatic changes in the technologies of both health care and information, the NCI has dramatically expanded its commitment to cancer communications to ensure that all Americans have access to the cancer information they need and are able to use it effectively. As articulated in the Fiscal Year 2001 and 2002 NCI Bypass Budgets, the Institute is committed to improve knowledge about, tools for, access to, and use of high quality, evidence-based cancer communications regardless of race, ethnicity, health status, education, income, age, gender, culture, or geographic region. Health communication research is a vibrant field concerned with the powerful roles performed by human and mediated communication (Kreps, Bonaguro, & Query, 1998). A wide range of scientists and communicators have been studying the process of effective communication and its impact on health for more than 25 years and much has been learned. There are increasingly refined theories of information processing, health communication and health behavior, including those that focus on how people represent and process health information, respond to cancer-related risks and change cancer-related behaviors. Intervention research on effective health communications has contributed to increasing proportions of Americans eating at least five fruits and vegetables per day, obtaining breast and cervical cancer screening, as well as to declining rates of smoking among many groups. Changes in the role and accessibility of information are altering health care practices, patient-physician relationships and the way consumers and patients acquire and use information (Eng, et al., 1998, 1999, Patrick, 1999). Activated, empowered patients and direct-to-consumer advertising are changing the nature of doctor-patient communications, and there is an opportunity to examine the impact of these altered relationships. Home computer and Internet use are on the rise, with a recent survey reporting that in the year 2000, personal computers were in 58 percent of all U.S. households, and 51 percent of all U.S. households had Internet access (PC Data Online, 2000). Approximately 70 million people searched for on-line health information in 1999, and cancer information was one of the most sought-after topics (Cyber Dialogue, 2000, Harris Poll, 1999). Both consumers and professionals have, or will have, a host of new opportunities for creating, distributing and acquiring health information from the World Wide Web, individually-tailored print and multimedia materials, interactive computer games, interactive kiosks, wireless devices, and many other channels and sources. But empirical evidence is critically needed about the efficacy and effectiveness of health communications interventions using these modalities. Data especially are needed about how these strategies can be used to meet the needs of diverse populations. A number of groups and reports, including most recently, the National Survey of Attitudes About Clinical Trials (The Cancer Letter, October 13, 2000), have emphasized the need for major new communication efforts about cancer clinical trials. With the rapid pace of discovery in the basic and clinical sciences, the aging of the U.S. population, the increasing population of cancer survivors, and the growing number of households in which someone is a caregiver for a person with cancer, the need and demand for high quality cancer information will continue to grow. Patients are increasingly being asked to make decisions about health care choices, such as whether to get a prostate specific antigen (PSA) test or what treatment to choose for breast or prostate cancer (e.g., Entwistle et al., 1998), and these decisions must be informed by effective communication. A significant proportion of patients are not satisfied with the communication component of their health care interactions, and want more information than they receive (e.g., Thorne, 1999). The development of effective interventions and tools for informed decision making should use the wealth of available evidence from fields such as education, instructional design, cognitive psychology, and human factors research. There is an evidence base that shows what can be achieved through decision aids, e.g., changes in knowledge and some other intermediate outcomes. More research is needed in these areas to develop interventions that can be extended beyond clinical settings as well as to additional, especially diverse, populations. The Science Panel on Interactive Communications and Health (Eng, 1999) concluded that few other health-related interventions have the potential of interactive health communications to simultaneously improve health outcomes, decrease health care costs and enhance consumer satisfaction. New information technologies, such as the Internet and World Wide Web, combine the attributes of both mass and interpersonal communication (Strecher, 1999). Yet, they should not replace older but effective strategies including mass media, one- on-one counseling, and tailored print communication. Existing and new technologies should be integrated based on scientific knowledge to provide a menu of choices. http://www.health.gov/scipich/pubs/finalreport.htm The increasing complexity of every element of cancer communications, from the understanding of cancer itself, to the rapid evolution of new media, to the recognition of the manifold needs of diverse audiences, demands a broadly interdisciplinary approach. Bringing people together from different disciplines can accelerate the speed with which discoveries are made, translated into researchable hypotheses and then developed into products that benefit people. A recent IOM report, Bridging Disciplines in the Brain, Behavioral and Clinical Sciences, stressed that "solutions to existing and future health problems will likely require drawing on a variety of disciplines and on approaches in which interdisciplinary efforts characterize not only the cutting edge of research, but also the utilization of knowledge" (IOM, 2000, p.2). Cancer communications will not be understood in a vacuum. Progress can be accelerated if clinicians work, for example, with psychologists, advocates, communication experts and patients to learn the best ways to engage patients in decision making or to talk about participation in clinical trials. Molecular biologists could collaborate with epidemiologists, psychologists, journalists, genetic counselors, computer scientists, high risk persons and others to determine how to communicate about genetic mutations that predispose to cancer risks. Mathematicians, decision scientists, and medical anthropologists might be engaged in research on cancer risk communication. In addition, research teams would benefit from people who understand how to communicate and market in compelling, engaging ways in order to transcend the deluge of competing media. The challenges of cancer communications will not be surmounted if disciplines work in isolation. (Applicants should note that these disciplines are provided as illustrative and are not prescriptive. The team needed for any project depends on the problem.) A significant increase in the size of the cancer communications research enterprise is needed to develop the next generation of research and interventions. At the same time, the enterprise must be informed by a greater understanding of the mechanisms by which these communications work and a commitment to diffusion. The result should be both knowledge and practical strategies to enhance cancer communications and improve the control of cancer. OBJECTIVES AND SCOPE In accordance with the National Cancer Institute’s Extraordinary Opportunity in Cancer Communications (see http://cancercontrol.cancer.gov/eocc), the NCI invites grant applications for Centers of Excellence in Cancer Communications Research (CECCR). CECCRs are expected to conduct research that will lead to major scientific advances in knowledge about cancer communications and their translation into practice. There are several over-arching goals. o Increase the number of investigators from relevant disciplines who focus on the study of cancer communications as part of interdisciplinary teams. o Increase the number of peer-reviewed publications in the area of communication processes. o Generate basic research evidence to improve understanding of the processes underlying effective cancer communication. o Produce evidence-based communication interventions that can be used to modify cancer risk behaviors and improve informed decision-making and quality of life. o Support novel interdisciplinary research to inform medical and public health practitioners about how best to communicate to the public, patients, and cancer survivors. o Increase the number of evidence-based interventions in under-studied areas, e.g., diagnosis, treatment, survivorship and end-of-life, and on understudied populations. o Train interdisciplinary investigators capable of conducting cutting-edge communications research directly relevant to the context of cancer prevention, detection, treatment, control, or survivorship. The focus can include, but is not limited to, cancer risk communication, evidence-based interventions to enhance cancer communication, communication methods for diverse and under-served populations, innovative communication strategies to increase informed decision making and participation in clinical trials, communication about genetic testing, survivorship and end of life issues, as well as communication interventions to improve cancer prevention and early detection behaviors. We also invite research to elucidate the psychological mechanisms underlying the cancer communication process, understand how people use cancer information, test innovative strategies to overcome the digital divide in access to cancer-related information, and develop and evaluate methods to enhance the dissemination of evidence-based cancer communication interventions. Researchers are encouraged to examine the ethical issues associated with cancer communications as well as the cost-effectiveness of evidence-based interventions. Messages and the way messages and information are developed, designed, displayed and communicated should be based on scientific evidence. Yet, there is little research on the usability of available cancer communications. Centers can conduct basic, intervention and diffusion research in a variety of settings, including laboratories, clinical and community settings. They do not have to cover all aspects of the cancer continuum, focus is expected. However, there should be a focus on translatability from basic to intervention research to dissemination and sometimes back again (Hiatt and Rimer, 1999). Where possible, evidence-based research products should be put quickly into the public domain through Web-based access using open source tools. CECCRs investigators will be encouraged to share tools not only among themselves but also with the larger community. Software and other tools, such as Common Gateway Interface (CGI) scripts and interactive data-gathering tools, should be thoroughly documented for purposes of replication and dissemination. Investigators must provide evidence that they have a mechanism in place by which to disseminate evidence-based products and interventions that emerge from this research. Reliance on or production of proprietary technologies that would inhibit dissemination and replication is discouraged. Applicants are encouraged to collaborate with other organizations. These may include any of the following, but the Centers are not required to do so nor are they limited to them: NCI-designated Comprehensive Cancer Centers, Cancer Information Service, Special Populations Networks, and other NCI-funded research projects, such as the Cancer Family Registries, Cancer Genetics Networks, Transdisciplinary Tobacco Use Research Centers (TTURCs) and other SPORES as well as the Centers for Disease Control and Prevention, the American Cancer Society and other voluntary health associations, the Robert Wood Johnson Foundation, National Science Foundation grantees, and industry. In addition, collaborations should be considered with universities, including Schools of Public Health, Historically Black Colleges and Universities, public health agencies, community technology centers and other organizations. The active participation of advocacy groups and appropriate community organizations is encouraged. Relevant collaborations with NIH intramural programs can be included as well. FOCUS OF CENTERS Overview Investigators should represent a broad range of disciplines working together to increase knowledge about cancer communications. Some centers might be virtual centers or collaboratories* where the expertise is drawn from multiple locations. Studies can focus on one-to-one communication, interpersonal methods, such as small groups, mass media, print and electronic communications, new media or combinations thereof. Since communication strategies do not exist in a vacuum, it is likely that applications that focus on only one communications strategy will be less competitive. To answer some questions, it may be appropriate to generate preliminary data via laboratory-based research and smaller-scale studies which permit highly controlled manipulation of the components of interventions before launching large-scale field trials crucial for determining effectiveness. The level of specialization in different aspects of cancer communications research will vary from center to center, e.g., topics, points on the cancer continuum, populations, levels of analysis and types of research. However, the centers should focus thematically on areas in which there are significant gaps in knowledge and critical needs--where focused, collective, interdisciplinary efforts could make a difference. It is incumbent upon investigators to articulate the gap areas. It is expected that the CECCRs will catalyze problem solving and lead to more rapid advances in knowledge than would be possible by depending on individual investigators working in relative isolation. CECCRs should contribute to understanding what works and what does not work and why. In most cases, the studies will require a recognition of the cognitive, psychological, and sociocultural influences on health behaviors. The sine qua non of the Centers consists of at least 3 research projects with an integrative theme, cores and plans for career development and use of developmental funds. Investigators are encouraged to include research projects that bridge basic and intervention research. Potential Research Topics Note that these are examples only and will not constitute evaluation criteria. Elucidate Basic Mechanisms in Cancer Communications o Answer questions about the mechanisms by which cancer messages exert their impact, including mediators of cancer risk communication. o Clarify how people seek, process and use health information and develop a greater understanding of how cognitive and emotional factors affect processing (Croyle, Sun, and Hart, 1997). Explain the Communication Process o Increase understanding of how people search for, use and respond to cancer information within the changing information environment and how this is affected by individual factors such as age, ethnicity, income, culture and personality. Improve Decision Making o Improve understanding of how patients process complex information about the benefits and risks of different medical options and make decisions in the face of considerable uncertainty (Croyle and Lerman, 1999). o Examine the impact of interventions to improve cancer-related decision making and the impact of activated patients upon patient-physician communication and family communication. Improve Risk Communication o A number of important topics in risk communication research were identified as high priorities by experts who attended an NCI-sponsored meeting on cancer risk communication (December 1998). The papers from the meeting were published in a September, 1999 supplement to the Journal of the National Cancer Institute and include many potential topics. Improve Communication for Diverse Audiences o Promote knowledge about, access to and use of cancer information for low literacy and other diverse audiences as well as children and adolescents affected by cancer. Design More Effective Interventions o Conduct research that contributes to an effective menu of communication choices for different audiences, including traditional communication methods, such as mass media, one-on-one and small group education strategies, print and telephone communication strategies, proactive strategies, such as telephone counseling and tailored print communications, and interactive technologies, such as the Internet, kiosks and CD-ROMs. What is the optimal mix of communication strategies? How do presentation and format interact to affect message impact? How can interventions be combined to maximize their impact? o Conduct research on the relative contribution to improved outcomes of varying amounts of message intensity, complexity, burden on receivers, and development costs. Evaluate stepped-care approaches to communications. Outcomes include not only behaviors but also health care costs, health care utilization, and quality-adjusted life years saved. o Examine the impact of integrated communications systems that include multiple channels of communication, including interpersonal, intrapersonal, mass media and new media to give people the information they want, how they want it, when and where they want it. Use of the New Media o Wired for Health (http://scipich.health.org/pubs/finalreport.htm) and the recent IOM report Networking for Health (http://www.nap.edu/catalog/9750.html) make a number of suggestions for research on the new media. Applicants interested in new media research are encouraged to consult these sources. Improve Interpersonal Communication o Examine the role of interpersonal, including physician and/or nurse and patient communication and group communication in promoting informed decision making, psychosocial adjustment, personal adaptation, and social support for individuals confronting cancer. Understand and Improve Diffusion of Best Practices o Identify the fundamental mechanisms that enhance diffusion to populations in contrast to the basic mechanisms underlying individual change over time (Abrams et al., 1999). Restrictions on Applications The NCI now funds many studies that compare tailored print interventions to usual care interventions or kitchen sink interventions to usual care. However, when these studies have not been successful in achieving significant impact, it usually has not been possible to identify the reasons. Research funded under this initiative should not be limited to studies that focus only on outcomes. Rather, the studies should represent a major advance in terms of innovation, theory testing, intervention strategy and methodology. A major emphasis should be to understand what works, what does not work and why, in order to identify generalizable principles and processes of communication. Research exclusively focused on health professionals is not appropriate. Proposals that are exclusively focused on outreach or service delivery also are not acceptable. SPECIAL REQUIREMENTS The Centers must include three or more individual research projects, which reflect hypothesis-driven research, pilot or developmental research projects, shared resources and career development. Centers must provide evidence of an interdisciplinary focus, including an explanation of how the projects fit together across disciplines to promote synergy and syntheses. Evidence of plans and mechanisms for dissemination of research findings and products, including evidence-based tools and interventions must be stated. Interactions among CECCRs are an important part of this initiative. Centers must identify creative strategies to foster formal and informal intra- and inter-center collaborations to identify and address overarching scientific and methodological issues. This may be in the form of research collaborations, participation in Web-based communication exchanges by scientists on a visiting basis, exchange of resources and materials, and other mechanisms. A requirement for all CECCR Principal Investigators and selected project investigators is participation in two meetings per year in the Washington, DC metropolitan area or other mutually convenient location. At least three project staff should be budgeted per meeting. Support for this travel should be included in the budget. The purpose of these meetings is to share scientific information, assess scientific progress, solve problems, identify new research opportunities, and establish priorities that will accelerate the translation of basic research findings to applied settings in patients and populations. Novel opportunities to facilitate collaboration also will be developed. Centers must include certification that meets the new requirement for education in human subject protections. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html MECHANISM OF SUPPORT Support of this program will be through the specialized center (P50) grant mechanism. Although this RFA uses a P50 mechanism, it is not a SPORE (Specialized Programs of Research Excellence). This mechanism supports the full range of research and development from basic to clinical and intervention studies. The spectrum of activities comprises a multidisciplinary approach on a specific disease entity or biomedical problem. These grants differ from traditional program project grants in that they are more complex and flexible in terms of the activities that can be supported. In addition to support for interdisciplinary research projects, support is also provided for pilot research projects, specialized resources, career development programs, and shared core facilities. Applicants will be responsible for the planning, direction, and execution of the proposed CECCR program. Awards will be administered under NIH grants policy as stated in the NIH Grants Policy Statement. The total project period for applications submitted in response to the present RFA may not exceed 5 years. The earliest anticipated award date is March 2002. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of awards will vary also. FUNDS AVAILABLE The NCI intends to commit approximately $10 million in FY 2002 to fund 4 to 5 new grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for direct costs of up to $1,500,000 per year, excluding Facility and Administrative costs on consortium arrangements. Because the nature and scope of the research proposed might vary, it is anticipated that the size of each award will also vary. Although the financial plans of the National Cancer Institute provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, it is not known if competing renewal applications will be accepted and/or if this RFA will be reissued. ELIGIBILITY REQUIREMENTS Applications may be submitted by 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Domestic applications with foreign components are permitted. To be considered, applicant organizations must have: (1) an established investigator as a Principal Investigator (PI) who can oversee and conduct planning activities, provide direction to the CECCR, ensure an interdisciplinary research emphasis, and build a career development program, and (2) full institutional commitment from the applicant institution. Clearly delineated and formally confirmed subcontracted, collaborative scientific arrangements with scientists from other institutions, including foreign institutions, may be included. 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: Gary L. Kreps, Ph.D., Chief Health Communication and Informatics Research Branch Behavioral Research Program Division of Cancer Control and Population Sciences National Cancer Institute 6130 Executive Blvd, MSC 7365, EPN Room 4084 Rockville, MD 20892-7365 Telephone: (301) 496-7984 FAX: (301) 480-2087 Email: gary.kreps@nih.gov Direct inquiries regarding review issues to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8109, MSC-8329 Rockville, MD 20852 (express courier) Bethesda MD 20892-8329 Telephone (301) 496-3428 Fax: (301) 402-0275 Email: tf12w@nih.gov Direct inquiries regarding fiscal matters to: Crystal Wolfrey Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Suite 243 Bethesda, MD 20892-7340 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-8634 E-mail: crystal.wolfrey@nih.gov LETTER OF INTENT Prospective applicants are asked to submit, by June 14, 2001, a letter of intent that includes a descriptive title of the proposed research, the name, address, telephone and FAX numbers, and email address of the Principal Investigator, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, it allows NCI staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to Dr. Gary Kreps listed under INQURIES, by June 14, 2001, the letter of intent receipt date. SCHEDULE Letter of Intent Receipt: June 14, 2001 Application Receipt Date: July 11, 2001 Peer Review Date: September/October 2001 Review by NCAB Advisory Board: February 2002 Earliest Anticipated Start Date: March 2002 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. Applications 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 301/710-0267, E-mail: grantsinfo@nih.gov. For those applicants with Internet access, the 398 kit may be found at http://grants.nih.gov/grants/forms.htm. Additional instructions for preparing a CECCR grant application are available from the program staff listed under INQUIRIES and can also be found at the following url link: http://cancercontrol.cancer.gov/communicationcenters. The instructions must be requested and used in preparing a CECCR application. CECCR Program Requirements The following information must be provided in the application: 1. A minimum of three fully developed RO1-type research projects, 2. Evidence of an interdisciplinary focus, including an explanation of how the projects fit together across disciplines to promote synergy and syntheses, 3. Shared administrative, technical, statistical, and other resources that can be justified, 4. A strong commitment to career development, with a plan included as part of the application. This may include new investigators or established investigators who wish to change research directions. Recruitment must include qualified women and minorities. To this end, each applicant should propose a clear policy and plan for recruitment of career development candidates. The CECCR application indicate potential mentors who are already in place at the proposed CECCR, briefly describe their research programs, and describe complementary activities that contribute to the interdisciplinary environment for career development (e.g., existing training grants, other career development mechanisms and relevant programs), 5. A proposal to promote developmental and pilot research to facilitate new collaborations and the opportunity to pursue challenging new ideas. It is important that CECCRs use pilot funds to stimulate projects that take maximum advantage of new research opportunities. Such projects may be collaborative among scientists within one or more CECCRs, or with scientists outside the CECCR environment. The CECCR application should propose an institutional review process that selects pilot projects for center funding that represent the most innovative and interdisciplinary ideas. The NCI is especially interested in opportunities to engage arts and sciences university faculties and schools of public health in collaboration with medical schools and/or cancer center faculty, 6. Creative strategies to foster formal and informal intra- and inter-center collaborations to identify and address overarching scientific and methodological issues. 7. Evidence of plans and mechanisms for dissemination of research findings and products, including evidence-based tools and interventions. 8. Certification that meets the new requirement for education in human subject protections. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html 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 Application Preparation/Submission The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive Room 1040 - MSC 7710 Bethesda, MD 20892-7710 (20817 for express service) At the time of submission, two additional copies of the application must also be sent to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8109, MSC-8329 Rockville, MD 20852 (express courier) Bethesda, MD 20892-8329 Applications must be received by July 11, 2001. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such an application must follow the guidance in the PHS Form 398 application instructions for the preparation of revised applications, including an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by the National Cancer Institute. Incomplete and/or non- responsive applications will be returned to the applicant without further consideration. 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 Division of Extramural Activities of the National Cancer Institute in accordance with the review criteria stated below. 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 the applications under review, will be discussed assigned a priority score, and receive a second level review by the National Cancer Advisory Board. It is a requirement for funding that at least three of the research proposals be approved by peer review. REVIEW CRITERIA The criteria to be used in the evaluation of grant applications are listed below. a. Research Projects: The Centers must include three or more individual research projects, which reflect hypothesis-driven research, pilot or developmental research projects, shared resources and career development. It is critical that there be evidence of the potential for a meaningful center with a real theme and identity. The application must represent more than an interesting collection of projects. Within the concept of translational research, reviewers will evaluate each research project using the criteria listed below. Each criterion will be addressed and considered by the reviewers in assigning the overall score project merit: a.1. Significance. The importance of the research objective to human cancer communication and its likelihood of completion within the project period. Does the research reflect a continuum from basic research to intervention or intervention to dissemination? Or, is there a strong potential for translation? a.2. Approach. The adequacy of the experimental design and methods to achieve the research objectives, clear evidence of co-leadership by a basic and more applied scientist in the conception, design and proposed implementation of the project. Are the conceptual research 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 interdisciplinary approaches? a.3. Innovation. Originality and novelty of the experimental design as it relates to cancer communication research. Does the project develop new methodologies or technologies in cancer communication? Does the research design reflect sufficient originality, novelty, and innovation to make it highly relevant to the overall goals and objectives of the CECCR? a.4. Investigators. The qualifications of co-investigators to conduct the proposed research and the appropriateness of the time commitments of each co- investigator to the conduct of the project. Are the investigators appropriately qualified with demonstrated competence to conduct the proposed research? Is the proposed work appropriate to the experience level of the principal investigator and project researchers? Are the proposed time commitments for all key laboratory and clinical researchers reasonable and adequately associated with the project? a.5. Environment. The scientific environment in which the research work will be done, and the unique features, if any, of the environment to support the proposed work. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed projects take advantage of unique and interdisciplinary features in the scientific environment and reach out to useful collaborative arrangements? Is there evidence of adequate institutional support? Is the project interactive with other components of the CECCR, conceptually, experimentally, and translationally? a.6. Interdisciplinary Collaboration. Is there evidence of significant interdisciplinary basic, clinical and public health interactions in the conception, design, and proposed implementation of the project? 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, and children 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. b. Shared Resources b.1. adequacy of the justification for specialized resources relative to its essential need for the conduct of CECCR research or pilot projects and CECCR collaborative projects, b.2. adequacy of qualifications and performance (if applicable) of managers of resources to conduct high quality, reliable resource operations, b.3. appropriateness of the requested budgets to conduct each resource operation. b.4. adequacy of plans for oversight of resources and the prioritization of work c. Career Development c.1. adequacy of the process and/or track record for selecting candidates for career development who demonstrate potential for independent research careers in interdisciplinary cancer communication-related research or who are established investigators and are changing the direction of their research careers, cross-disciplinary training should enable scientists to bridge scientific domains in health communication research, to foster important integrative scientific inquiry c.2. adequacy of the procedures and/or track record to seek out and include qualified minorities, women, and persons with disabilities in the career development program, c.3. adequacy of the individuals available in the program to serve as possible mentors of career development candidates, the current availability and adequacy of projects for career development candidates c.4. appropriateness of the budget relative to the proposed plans for sustaining a significant activity in career development. Stipends and trainee costs are not allowable. However, salary support for career development candidates may be required. c.5. complementary activities that contribute to the environment for career development c.6. capacity of the overall program to absorb career development candidates and prepare them for independent interdisciplinary cancer communication- related research careers d. Developmental Research Program d.1. adequacy of the process and/or track record for attracting new ideas for pilot studies within the CECCR. d.2. adequacy of the proposed process and/or track record for continuously reviewing and funding a spectrum of pilot projects (e.g., research, technology development, resources) for their quality, innovativeness, interdisciplinary nature and importance to translational research that will have an impact on enhancing cancer communication efforts and developing innovative new cancer communication programs. d.3. general quality of the pilot projects provided by the CECCR to demonstrate the effectiveness of the process and/or track record of funding pilot projects, d.4. appropriateness of the budget relative to the needs and demonstrated capabilities of the SPORE and potential of the program to generate innovative pilot projects on a consistent basis d.5. degree to which developmental funds will be used to stimulate pilot projects with interdisciplinary interactions and/or collaborative interactions with other scientists within or outside of the parent institution, and especially with other NCI-funded centers and large-scale programs e. Overall Program Organization and Capability e.1. scientific qualifications and involvement of the Principal Investigator, as well as his/her demonstrated scientific and administrative leadership capabilities, adequacy of the time commitment of the Principal Investigator, e.2. interdisciplinary nature of the proposed research activities, integration of the projects around an overarching theme, and plans to effectively pursue interdisciplinary research objectives, e.3. adequacy of access to patients and populations for conducting current and projected research, e.4. adequacy of the procedures, processes, and plans for promoting interdisciplinary interactions, including coordination, interaction, collaboration and synthesis, e.4. facilitation of technology transfer, management of the intellectual property rights of the CECCR under the requirements of the Bayh-Dole Act and NIH funding agreements, e.5. written assurance that CECCR interactions with commercial entities will uphold the principles of academic freedom, including the ability of CECCR investigators to collaborate freely, and to send and receive biomedical research materials without restriction to other scientific researchers. e.6. evidence of full protection of human subjects for clinical research components, and appropriate mechanisms for the rigorous management and verification of research data, e.7. plans for the recruitment and retention of research subjects and patients and adequacy of those plans to include both genders, minorities and their subgroups, and children as appropriate to meet the scientific goals of the research, e.8. adequacy of plans for dissemination of evidence-based interventions. f. Interactions with Other CECCRs funded in response to this RFA f.1. adequacy of plans to promote and maintain communication and integration of scientific projects of mutual interest with other CECCRs, f.2. willingness to interact with other CECCRs and with the NCI in sharing information, in assessing scientific progress, in identifying new research opportunities and in establishing scientific priorities. g. Institutional Commitment g.1. Adequacy of facilities, equipment and space to promote interdisciplinary and translational research objectives, g.2. Adequacy of institutional procedures and plans for monitoring, evaluating, and assuming accountability for the general success of the CECCR, g.3. Adequacy of the institutional infrastructure for assessing progress and needs. OVERALL EVALUATION AND SCORING OF APPLICATIONS A single numerical priority score will be assigned to the CECCR application as a whole after discussing all of the review elements listed above. The score will be based on the overall quality of the research projects, the career development program and the developmental research program, the overall effectiveness and adequacy of shared resources, the overall program organization and capability, and the plans for interactions with other CECCRs. Although primary emphasis will be placed on scientific merit, significant consideration will also be given to interdisciplinary interactions, potential for impacting on the disease, inter-Center collaborations and institutional commitment. AWARD CRITERIA Applications recommended by the National Cancer Advisory Board will be considered for award based upon (a) scientific and technical merit reflected in the priority score, (b) program balance, including in this instance, sufficient compatibility of features to make a successful collaborative program a reasonable likelihood, and (c) availability of funds. 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 that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators may also obtain copies of these policies 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 policy that was 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. 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. 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 RFA, Centers of Excellence in Cancer Communications Research, is related to priority area of cancer prevention and control. NCI’s commitment to cancer communications is consistent with the Department of Health and Human Service’s expanded health communication effort for "Healthy People 2010." Healthy People 2010 defines health communication as the research-based crafting and delivery of messages and strategies to promote the health of individuals and communities. It is as important to prevention as to treatment and as relevant to research as to the NCI’s public service functions. This effort will permeate all NCI Divisions. 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 and 93.393. Awards are made under authorization of 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 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. *Originally coined by the National Science Foundation by combining "collaboration" and "laboratory," collaboratories are secure, user- configurable, virtual project spaces. Geared towards fostering inter- organizational teamwork, they contain rich tools and services for research and development projects that span organizations, geographic regions, and time zones. References 1. Abrams DB, Mills S, Bulger D. Challenges and future directions for tailored communication research. Annals of Behavioral Medicine 1999, 21(4):299-306. 2. Cancer Risk Communication: What we know and what we need to learn. Journal of the National Cancer Institute Monographs 1999, (25). 3. Croyle, RT, Lerman, C. Risk communication in genetic testing for cancer susceptibility. Journal of the National Cancer Institute, 1999, 25: 59-66. 4. Croyle, RT, Sun, Y, Hart, M. (1997). Processing risk factor information: Defensive biases in health-related judgments and memory. In K. Petrie & J. Weinman (Eds.), Perceptions of Health and Illness: Current Research and Applications (pp.267-290). London: Harwood Academic Publishers. 5. Cyber Dialogue. (October 27, 2000). Internet health seekers reach critical mass. Cyber Dialogue Re:Sources. http://www.cyberdialogue.com/news/index.html. 6. DHHS. Healthy People 2010 (Conference Edition, in Two Volumes). Washington, DC: January 2000. 7. Eng TR, Maxfield A, Patrick K, Deering MJ, Ratzan SC, Gustafson DH. Access to health information and support: A public highway or a private road? JAMA 1998, 280(15) 1371-5. 8. Eng TR, Gustafson DH, Henderson J, Jimison H, Patrick K. Introduction to evaluation of interactive health communication and applications. American Journal of Preventive Medicine 1999, 16(1) 10-15. 9. Entwistle VA, Sheldon TA, Sowden A, Watt IS. Evidence-informed patient choice: Practical issues of innovating patients in decisions about health care technologies. International Journal of Technology Assessment in Health Care 1998, 14(2) 212-225. 10. Fiore, MC, Bailey, WC, Cohen, SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health. June 2000. 11. Harris Poll. (December 22, 1999). Online population growth surges to 56% of All Adults. The Harris Poll, #76. 12. Hornik, R. (1997). Public health education and communication as policy instruments for bringing about changes in behavior. In M.E. Goldberg, M. Fishman (ed), et al. Social Marketing: Theoretical and practical perspectives. Advertising and consumer psychology. (pp. 45-48). Mahwah, NJ, U.S.: Lawrence Erlbaum Associates, Inc., Publisher. xv, 457 pp. 13. Institute of Medicine and National Research Council Report: Ensuring Quality Cancer Care (1999). Washington, D.C: National Academy Press. 11. Institute of Medicine: Bridging Disciplines in the Brain, Behavioral, and Clinical Sciences (2000). Washington, D.C: National Academy Press. 12. Kreps GL, Bonaguro EW, Query JL Jr (1998). The history and development of the field of health communication. In L.D. Jackson and B.K. Duffy (eds.), Health Communication Research, (pp. 1-15). Westport, CT: Greenwood Press. 13. Lerman C, Hughes C, Croyle RT, Main D, Durham C, Snyder C, Bonney A, Lynch JF, Narod SA, Lynch HT. Prophylactic surgery decisions and surveillance practices one year following BRCA 1 / 2 testing. Preventive Medicine 2000, 31:75-80. 14. Miller TE, Reents S. The health care industry in transition: The online mandate to change. Cyber Dialogue for Intel Corporation 1998. 15. O Connor AM, Fiset V, DeGrasse C, Graham ID, Evans W, Stacey D, et al. Decision-aids for patients considering options affecting cancer outcomes: evidence of efficacy and policy implications. Monogr Natl Cancer Inst 1999, 25:67 80. 16. Park, DC, Morrell, RW (ed), et al. Processing of medical information in aging patients: Cognitive and human factors perspectives. (pp. 199-219). Mahwah, NJ, USA: Lawrence Erlbaum Associates, Inc. 17. Patrick K. Prevention, public health, and interactive health communication. American Journal of Preventive Medicine 1999,16(1) 46-47. 18. PC Data Online. (April 26,2000). Net Portrait & trade, Reveals demographics of home Internet users in U.S. PC Data Online Reports. http://www.pcdataonline.com/press/pcdo042600.asp. 19. Roter, DL, Hall, JA. (1992). Doctors talking with patients/patients talking with doctors: Improving communication in medical visits. Westport, CT, USA: Auburn House/Greenwood Publishing Group, Inc., xii, 203. 20. Skinner CS, Campbell MK, Rimer BK, Curry S, Prochaska JO. How effective is tailored print communication? Annals of Behavioral Medicine 1999, 21(4):290-298. 21. Strecher, VJ, Greenwood, T, Wang, C, Dumont, D. Interactive multimedia and risk communication. Monogr Natl Cancer Inst 1999, 25:134-139. 22. Thorne, SE. Communication in cancer care: What science can and cannot teach us. Cancer Nursing 1999, 22(5): 370-378. 23. Science Panel on Interactive Communication and Health. Wired for health and well being: The emergence of interactive health communication. Office of Disease Prevention and Health Promotion. U.S. Department of Health and Human Services, 1999. Washington, D.C. 24. Whaley, BB (ed) et al. Explaining illness: Research, theory, and strategies. LEA’s Communication Series. (pp. 171-194). Mahwah, NJ, U.S.: Lawrence Erlbaum Associates, Inc.


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