CANCER COMMUNICATION AND INTERACTIVE MEDIA TECHNOLOGY Release Date: August 16, 1999 PA NUMBER: PAR-99-141 National Cancer Institute Letter of Intent Receipt Date: October 6, 1999 Application Receipt Date: November 8, 1999 PURPOSE Communication is central to effective, quality cancer care, from primary prevention to survivorship. The continuing evolution of media technology offers multiple opportunities to inform health professionals and the public about cancer information and care in better ways. This Program Announcement (PA) is designed to promote and support collaborations between non-profit organizations and for-profit small businesses on research projects that address 1) communication with individuals over great distances and in non- invasive ways about healthy practices known to reduce cancer risks; 2) risk reduction communication training for health professionals; and/or the 3) development of organizational infrastructures needed to facilitate rapid advances in knowledge about cancer communications, testing of intervention strategies, tailoring models and tools, and dissemination of results. The National Cancer Institute (NCI) is interested in the development, implementation, and testing of innovative and commercially viable health applications using interactive media technologies, television, or radio that translate cancer research into population specific applications needed by health care professionals or the public to reduce cancer risks, provide treatment options, or address the needs of cancer survivors. Research areas include innovative alternative teaching methods; healthy life style models, nutrition interventions, tobacco cessation interventions; tailored interventions for specific populations including people with disabilities; educational, training, or tracking systems for primary care professionals or for the public; telehealth or telemedicine applications; counseling models for cancer genetics; interventions to enhance cancer-related decision making; psychosocial interventions for cancer survivors; models to resolve organizational infrastructure issues; and complementary medicine approaches to cancer. This PA utilizes the R25 and R44 grant mechanisms in tandem to expedite the transition of successful technology research and development into practical applications. 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 activities for setting priority areas. This PA, Cancer Communication and Interactive Media Technology, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No.017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/512-1800). ELIGIBILITY REQUIREMENTS For this PA, domestic public or private non-profit organizations such as universities, colleges, hospitals, foundations, and State and local governments may apply for the R25. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Prior to submission, the R25 applicant must partner with a for- profit small business who agrees to prepare the R44 section of the application. The small business must be independently owned and operated by a United States citizen or permanent resident alien, whose principal place of business, including any affiliates, is in the United States. The business can not employ more than 500 employees (SBIR OMNIBUS SOLICITATION: https://grants.nih.gov/grants/funding/sbir.htm). For this PA, the R25 principal investigator must be retained by the small business as the primary consultant in the R44 phase of the project. The Principal Investigator during the R44 phase must come from the small business. MECHANISM OF SUPPORT Support for this program announcement is through the NIH Cancer Education and Career Development Grant (R25), and the Fast Track Small Business Innovation Research (SBIR) Grant (R44). The R44 Fast Track mechanism is a set-aside program described in the SBIR OMNIBUS SOLICITATION (https://grants.nih.gov/grants/funding/sbir.htm). This is a one-time PA, which may be reissued. The R25/R44 is a newly established NIH funding mechanism that provides a second phase of support for innovative cancer communication and technology research initiated under the R25 mechanism. Conversion of the R25 to the R44 phase will be based on the successful completion of negotiated milestones that will result in expediting research into practical commercial applications. This alternative funding mechanism: 1) allows the R25 principal investigator to participate in commercialization of the developed end-product; 2) receives one review for three separate applications, and 3) minimizes the funding gap between the R25 and the two-phase R44. Applications for R25 support alone will not be accepted for this PA. The R25/R44 application has three sections which must be submitted at the same time with their own face page: the R25, and Phases I and II of the R44 SBIR Fast Track, hereafter referred to as the R44. The total project period for this PA may not exceed four years: R25: 12 months; R44 - Phase I: 6-12 months, Phase II: 2 years. The one-year R25 and the R44 Phase I may not exceed direct costs (excluding third party IDC) of $100,000 each. Applicants requesting in excess of $500,000 dollars direct costs in either year of the R44 Phase II must have approval from NCI Program staff prior to submission. It is strongly recommended that applicants contact NCI staff at an early stage of application development to convey critical information, such as potentially large budget requests or to discuss programmatic responsiveness of the proposed project. Early contact with NCI program staff, listed under INQUIRIES, is critical to this PA since it utilizes a new funding mechanism. The planning, direction, and execution of the proposed project is the sole responsibility of the applicant. Awards will be administered under NIH grants policy as stated in the NIH Grants Policy Statement, NIH Publication No 99-8, October 1998. RESEARCH OBJECTIVES Effective communication and its impact on health have been the focus of scientists and communicators for more than 25 years. In 1971, the National Cancer Act charged NCI with the dissemination and interpretation of scientific and other information regarding the causes, prevention, detection and treatment of cancer for practitioners, other health professionals, scientists, and the general public. Within the past decade, NCI has utilized a wide array of technologies to expand cancer communications to ensure that all Americans have access to the cancer information they need. As a result of these efforts, it has become apparent that there is a need to increase the demand for and expand the use of these technologies by the public, patients, high-risk persons, advocates, survivors and health professionals regardless of race, ethnicity, health status, education, income, age, gender, or geographic region. There is evidence that communication technologies are altering health care practices, patient-physician relationships and the way consumers and patients acquire and use information. Effective health communications have influenced American adults to increase their daily consumption of fruits and vegetables, to get screened for breast and cervical cancers, and to stop or limit their use of tobacco products. Today's technology users are often as informed or more informed than their physicians because of new opportunities for acquiring health information from the World Wide Web, individually-tailored print, multimedia products such as cancer-specific CD-ROMs, interactive computer games, interactive kiosks, and wireless pagers, among others. The current communications revolution offers better ways to train health care professionals on how to utilize technology to reach people with cancer information, and simultaneously improve health outcomes, decrease health care cost, and enhance consumer satisfaction. However, before we can train health professional to effectively communicate about cancer or develop effective interactive health communication products and interventions, we need to learn how people seek, process and use health information. Proactive communication strategies are needed across the cancer continuum to rapidly accelerate a reduction in the cancer burden and across the life span. In order to be successful, these strategies would have to cover a broad cross- section of the U.S. population to reach the most vulnerable population groups. Communications research is also needed among diverse population groups on how to increase their demand for access to cancer information (children, ethnic minorities, recent immigrants, low income groups, low literacy groups, rural populations, older adults and people at high-risk because of previous diseases, behaviors, exposures, genetic susceptibility or some other factor, patients, survivors, and health providers.) Cancer communications research should be science-based, developed in collaboration with consumers, industry and academia, and result in high- quality products that have been evaluated for utilization, efficacy and impact on the target audiences. Anticipated results should include, but are not limited to, mechanisms for removing cost barriers; tools to increase familiarity, ease of use, appeal and vividness; culturally appropriate interventions; comprehensive and relevant messages; a flexible and adaptable menu of communication choices to reach the public, patients, underserved populations, survivors, and health providers in a variety of settings; and developed infrastructures, in health care and community settings, needed to facilitate rapid advances in knowledge about cancer communications, testing of strategies, models and tools, dissemination of results to researchers, clinicians, patients, practitioners, advocacy groups and other partners and the public. Objectives and Scope Interested applicants are encouraged to develop systems, interventions, programs and/or products that: 1) improve transmission of cancer information; 2) promote cancer-related behavior change; 3) reduce cancer risk among youth and adults; 4) improve health outcomes and quality of life; 5) improve decision making and adherence to cancer prevention, detection and treatment; and 6) improve survivorship. Research in any of the following areas is considered to be appropriate. These illustrative examples are not all inclusive. Applicants could address one or a combination of these needs. Technology tools to facilitate these types of research include, but are not limited to, computer software, expert systems, tracking databases, advanced telephone technologies, videotext, cable or broadcast television, radio, virtual reality, animation, imaging, and the World Wide Web. For any of the following, it is important for applicants to indicate the ultimate value of their research and how it will increase the knowledge about cancer communications. COMMUNICATION TOOLS --- Develop evidence-based strategies for involving the public, children and people from vulnerable, high-risk populations in programs to prevent or stop tobacco use; improve dietary practices and increase physical activity; participate in cancer screening or treatment, prolong survivorship, and other areas noted above. --- Develop new tools, products, and methods to enhance information dissemination and strategies to improve the penetration, efficacy, effectiveness and dissemination of cancer communications based on how people search for and use cancer information. Develop optimal formats for communicating cancer risks to culturally sensitive to diverse audiences. --- Develop guidelines for users to determine the quality of health information on the Web or viewed through other interactive health communication technologies. --- Develop strategies for teaching people how to separate important from insignificant risks and deal with contradictory health messages so that they can make informed choices. --- Develop practical decision aids to improve patient-provider communication and to help people make better cancer-related decisions. --- Develop health communication technology tools to assist physicians in maximizing their communication about cancer and integrating cancer communications into all aspects of cancer care. --- Develop practical tailored strategies to enhance cancer communications and address barriers that prevent major segments of the population from seeking and/or using cancer information. --- Develop products that present balanced information about complementary cancer therapies. SYSTEMS --- Develop systems or models for using interactive health communication technologies in organizational infrastructures (hospitals, clinics, HMOs, schools, worksites) that resolve barriers to use. --- Develop long-term cancer communication tracking systems that monitor outcome measures. --- Develop integrated systems of cancer information from prevention through treatment to survivorship and to end-of-life issues including palliative care and pain management that is consistent with 1999 recommendations from the Institute of Medicine (http://www4.nas.edu/) (under other reports). --- Develop integration systems of cancer care and best practices information on how to communicate uncertainty about risks, and reduce disparities in demand for, access to, and use of cancer communications. --- Develop information systems for the public or health care providers that give people the information they want, how they want it, when and where they want it. TRAINING --- Develop training modules for instructors to teach medical, nursing, and public health students to translate cancer research findings into population specific applications using a variety of multimedia technology. --- Develop training modules for persons who cover scientific or medical meetings and present the information in writing or through different forms of media technology. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research." These guidelines have been published in the Federal Register (March 20, 1994 (FR 59 14508-14513), in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994, and are available at: https://grants.nih.gov/grants/guide/1994/94.03.18/notice-nih-guideline008.html. 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". A copy of the Policy can be found in the NIH Guide for Grants and Contracts, March 6, 1998, or at: https://grants.nih.gov/grants/funding/children/children.htm LETTER OF INTENT Prospective applicants are asked to submit, by the date listed in the heading of this program announcement, a letter of intent that includes a descriptive title of the proposed research, the name, address, telephone number and Email of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the PA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NCI staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to Connie Dresser, at the address listed under INQUIRIES. APPLICATION PROCEDURES R25/R44 Contents The R25/R44 is submitted as one application and consists of three sections, each with its own face page: 1) the R25 (form PHS 398); 2) the R44 Phase I (PHS 6246-1); and 3) the R44 Phase II (PHS 6246-2). R25/R44 applications must be post marked by November 8, 1999. The PA title and number must be typed on line 2 of all three face pages. The R25/R44 application will be assigned a single priority score. As discussed in the REVIEW CONSIDERATIONS section, the initial review panel has the option of scoring only the R25 or only the R25 and the R44 Phase I. An unscored R44 Phase II will reflect upon the judgement of the applicant. For these reasons, clear and complete goals and feasibility milestones for each section of the R25/R44 application are critical. R25 Application and Preparation The R25 is to be submitted on form PHS 398 (rev. 4/98) and prepared according to the instructions provided unless specified otherwise within this section. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: [email protected]. Applications are also available on the web at: https://grants.nih.gov/grants/forms.htm The R25 should state the overall justification and objectives of the entire R25/R44 project and how and who will conduct the research. The R25 part of the application includes content development and focus group review that must be completed prior to the beginning of the R44 Phase I. For example, if a training module is proposed, the entire content of the training module is developed "on paper" and focus groups of experts and end-users are convened to critique and assist with the refinement of the final "paper" product that is to be developed, implemented, and evaluated in R44 Phases I and II. The R25 must include a "Milestones" section, following the Research Plan, that describes the research aims and measures of feasibility that justify transition to the R44 Phase I. The milestones must be quantifiable and scientifically justified and relevant to R25 progress and the successful completion of the R44 Phase I. Applications lacking this information, as determined by the NCI program staff, will be returned to the applicant without review. In the R25 budget justification section, a timeline and a dollar level for all three phases (R25, R44 Phase I, R44 Phase II) must be included. This should be in chart format and include direct as well as total costs for all three phases separately and as an aggregate. The release of funds for the R44 Phases I and II will be based on topics discussed in the REVIEW CONSIDERATIONS section. R44 Application and Preparation The R44 section consists of Phases I and II of the SBIR Fast Track. Electronic application forms for R44 Phase I - PHS 6246-1 (1/98) and R44 Phase II - PHS 6246-2 (1/98) are available at: https://grants.nih.gov/grants/funding/sbir.htm https://grants.nih.gov/grants/funding/sbir1/toc.htm https://grants.nih.gov/grants/funding/sbir2/index.htm General instructions for their preparation can be found in the electronic version of the SBIR OMNIBUS SOLICITATION at the "Small Business Funding Opportunities" website: https://grants.nih.gov/grants/funding/sbir.htm. Detailed information is available at: https://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf Applications for R44 Phases I and II (PHS 99-2) and instructions for their preparation in hard copy may be obtained from the PHS SBIR/STTR Solicitation Office, Phone: (301) 206-9385; Fax: (301) 206-9722; email [email protected]. As described in OMNIBUS SOLICITATION, both R44 Phases I and II must be completed, each with its own face page. All of the instructions within the OMNIBUS SOLICITATION apply with the following exceptions: -Special receipt date -Initial review convened by the NCI Division of Extramural Activities -Additional review considerations. -More flexible time and budget specifications -Inclusion of a Product Development Plan Appendix in the R44 Phase I Both Phases of the R44 must include specific aims and the feasibility milestones that would justify transition from the R44 Phase I to the Phase II. The Phase I must include a specific section labeled "Milestones," followed by a Research Plan. Milestones should be well described, quantifiable, scientifically justified and relevant to the progress of the Phase I and the successful completion of the Phase II. Applications lacking this information, as determined by the NCI program staff, will be returned to the applicant without review. In the R44 Phase I, the applicant is responsible for testing the feasibility of translating the "paper" product, developed in the R25, to a form of media technology with a group of experts and end-users. In the R44 Phase II, the applicant is expected to develop the technology transfer medium, and implement and test the efficacy and effectiveness of the product with specific populations. A detailed product development plan and a business plan for distribution must be included. Program highly recommends that all applicants locate potential backers for the commercialization of the final product prior to submitting the R25/R44. Release of R44 Phase I funds is contingent upon the successful completion of the milestones described in the R25. Likewise, release of R44 Phase II funds are contingent upon the successful completion of the milestones described in the R44 Phase I. If an application is received after the application receipt 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 PA that has been submitted as a traditional SBIR, unless the applicant withdraws the pending SBIR application. The R25/R44 application (R25, R44 Phase I and R44 Phase II in one package) and three legible copies of the entire application package must be sent or delivered to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application package must be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 636, MSC-7399 Bethesda, MD 20892-7399 Rockville, MD 20852 (for express/courier service) REVIEW CONSIDERATIONS Upon receipt, the R25/R44 application will be reviewed by the CSR for completeness and by the NCI for responsiveness. Applications not adhering to application instructions described above and those applications that are incomplete or non-responsive will be returned to the applicant without review. Applications will be reviewed for scientific and technical merit and the documented ability of the investigators to meet the RESEARCH OBJECTIVES of this PA by an initial review group convened by the NCI Division of Extramural Activities, 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 the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. Reviewers reserve the right to score the entire R25/R44 application, only the R25, or the R25 and the R44 Phase I. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. The reviewers will evaluate each of the three sections as described below (R25, R44 Phase I, R44 Phase II). Following this evaluation and the evaluation of issues included under "Additional Considerations," a single score will be assigned to the R25/R44. R25 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 be on the concepts or methods that drive this field? To what degree does the technology support the needs of the targeted research community? 2. Approach. Are the conceptual frameworks, 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? Is the time frame appropriate for completing the description of the content, design, and operation of the proposed health communication application? How easy will it be to use the proposed health communication application? 3. Milestones. How appropriate are the proposed milestones against which to evaluate the demonstration of feasibility for transition to the R44 phases? 4. Innovation. Does the project employ novel concepts, approaches or method? Are the aims original and innovative? 5. 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)? 6. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Is there evidence of institutional support? R44 Phases I and II The following criteria, described in the OMNIBUS SOLICITATIONS, are emphasized for this PA: 1. The soundness and technical merit of the proposed approach. 2. The qualifications of the proposed principal investigator, supporting staff, and consultants. 3. The scientific and technological innovation of the proposed research. 4. The potential of the proposed research for commercial application. 5. The appropriateness of the budget requested. 6. The adequacy and suitability of the facilities and research environment. 7. Adequate assurances detailing the proposed means for safeguarding human subjects 8. Innovative aspects of the approaches used in delivering cancer communication. The R25 and the R44 Phase I must specify clear, measurable goals (milestones) that should be achieved prior to initiating the R44 Phase II. A MILESTONES section must be included in both the R25 and the R44 Phase I. Failure to provide clear, measurable goals may be sufficient reason for the initial review group to judge the application non-competitive. Additional Considerations For the overall application, the initial review group will evaluate the specific goals for each of the three sections of the R25/R44 and the feasibility milestones that would justify expansion from the R25 to the R44. A single priority score will be assigned to the overall application if it receives a priority score. As with any grant application, the initial review group has the option of recommending support for a shorter duration than that requested by the applicant. This may result in a recommendation that only the R25 or the R25 and R44 Phase I be supported, based on concerns related to the applicant's specific goals and the feasibility milestones justifying expansion to the subsequent phases. Non-meritorious content may result in the deletion of any section of the R25/R44 by the review panel and will affect the merit rating of the application. The initial review group will also examine: the appropriateness of the proposed project budget and duration; the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the provisions for the protection of human subjects; and the safety of the research environment as well as the adequacy of plans for including children as appropriate for the scientific goals of the research, or justification for exclusion. (See section on NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS). AWARD CRITERIA Funding decisions for the R25 and R44 Phases I and II will be based on quality of the proposed project as determined by peer review, program priority, potential for clinical success, and availability of funds. Schedule Letter of Intent Receipt Date: October 6, 1999 Application Receipt Date: November 8, 1999 National Cancer Advisory Board Review: May 2000 Earliest Anticipated Award Date: July 2000 INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Connie Dresser, RDPH, LN Division of Cancer Control and Population Sciences National Cancer Institute Executive Plaza North, Room 232 Bethesda, MD 20892-7330 Telephone: (301) 496-8520 FAX: (301) 480-6637 Email: [email protected] Direct inquiries regarding fiscal matters to: Ms. Kathleen Shino Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892-7150 Telephone: (301) 496-8635 FAX: 301/496-8601 Email: [email protected] Direct inquiries regarding review matters to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 636, MSC 7399 Bethesda MD, 20892-7399 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496 -3428 FAX: (301) 402-0275 Email: [email protected] 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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