10
Research Trends and Opportunities

The United States is at a crossroads in cancer prevention research. Basic science and epidemiology are advancing knowledge in a number of areas, from the relationship between cancer and modifiable behavioral risk factors all the way down to the molecular pathways that mediate the actions of those risk factors. At the same time applied research is illustrating how the already vast amount of available evidence can be better used to more rapidly reduce cancer rates. To effectively reduce the cancer burden in the United States, however, there needs to be greater emphasis on action-oriented research (Colditz, 1997, 2001; Wegman, 1992). Knowledge about health problems and their causes does not automatically guarantee that appropriate actions are taken. Only when etiological knowledge is linked to evidence on the effectiveness of behavioral change strategies, and, in turn, to public awareness and policy support can the potential to reduce the burden of cancer be realized.

In this chapter the National Cancer Policy Board describes the range of research activities in the field of cancer prevention and early detection, with a focus on translational research—the research needed to move the fruits of research into provider and community practice. The chapter also presents estimates of the level of cancer prevention and early detection research through an analysis of publication trends in cancer prevention and control and a description of the current research portfolios of selected federal and private research sponsors.



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Fulfilling the Potential of Cancer Prevention and Early Detection 10 Research Trends and Opportunities The United States is at a crossroads in cancer prevention research. Basic science and epidemiology are advancing knowledge in a number of areas, from the relationship between cancer and modifiable behavioral risk factors all the way down to the molecular pathways that mediate the actions of those risk factors. At the same time applied research is illustrating how the already vast amount of available evidence can be better used to more rapidly reduce cancer rates. To effectively reduce the cancer burden in the United States, however, there needs to be greater emphasis on action-oriented research (Colditz, 1997, 2001; Wegman, 1992). Knowledge about health problems and their causes does not automatically guarantee that appropriate actions are taken. Only when etiological knowledge is linked to evidence on the effectiveness of behavioral change strategies, and, in turn, to public awareness and policy support can the potential to reduce the burden of cancer be realized. In this chapter the National Cancer Policy Board describes the range of research activities in the field of cancer prevention and early detection, with a focus on translational research—the research needed to move the fruits of research into provider and community practice. The chapter also presents estimates of the level of cancer prevention and early detection research through an analysis of publication trends in cancer prevention and control and a description of the current research portfolios of selected federal and private research sponsors.

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Fulfilling the Potential of Cancer Prevention and Early Detection DEFINING TRANSLATIONAL RESEARCH IN CANCER PREVENTION AND EARLY DETECTION Research on ways to promote the widespread adoption of evidence-based prevention and early detection interventions generally falls under the rubric of cancer control research, health services research, or, more specifically, applied or translational research. The definition of cancer control research has evolved over time but generally involves behavioral, social, and population sciences and spans the continuum of interventions aimed at cancer, from dietary recommendations for the prevention of cancer to the use of palliative care services to alleviate suffering at the end of life (Box 10.1). Health services research is a multidisciplinary field of inquiry, both basic and applied, that examines the use, costs, quality, accessibility, delivery, organization, financing, and outcomes of health care services to increase knowledge and understand the structure, processes, and effects of health services for individuals and populations (Institute of Medicine, 1995a). Both cancer control and health services research can be defined broadly to include behavioral and psychological research, evaluations of programs that may fall outside the purview of the traditional health care systems (e.g., school-based health programs), and randomized controlled clinical trials (e.g., studies of the effectiveness of health care technologies in situations representative of community practice). Other disciplines and research frameworks such as those from sociology, anthropology, economics, and political science are also relevant to cancer prevention and early detection. A hallmark of such research is its BOX 10.1 Evolving Definition of Cancer Control Research Cancer research seeks to find the means for combating cancer, whereas cancer control is concerned with identifying, community testing, evaluating, and promoting the application of cancer control means that are found (1975). Cancer control research is the reduction of cancer incidence, morbidity, and mortality through an orderly sequence from research on interventions and their impacts in defined populations to the broad, systematic application of the research results (1985). Cancer control encompasses a full spectrum of research in the behavioral, social, epidemiological, and population sciences aimed at creating or enhancing interventions that, by themselves or in combination with biomedical approaches, reduce cancer risk, incidence, morbidity, and mortality, and improve quality of life (2000). SOURCE: Hiatt and Rimer (1999) and National Cancer Institute (2000b).

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Fulfilling the Potential of Cancer Prevention and Early Detection TABLE 10.1 Types of Research Necessary to Improve the Application of Evidence-Based Cancer Prevention and Early Detection Interventions Question Example Examples of Types of Research Needed 1.What do we know? • Smoking causes cancer • Basic biomedical research • Epidemiological research 2.What works? • Behavioral counseling, pharmacological interventions, and policies to increase the price of cigarettes to reduce smoking • Intervention research (e.g., clinical trials) • Surveillance research • Program evaluation • Health services research • Meta-analyses 3.Where are we? • Certain populations are at high risk for cancer (e.g., 35 percent of adolescents smoke) • Effective interventions are not being applied (e.g., half of primary care providers are not asking smokers about their habit) • Surveillance systems (e.g., national behavioral risk surveys) • Health services research (e.g., patterns of care studies) 4. How can we do better? • Physicians provided with continuing education and office reminder systems improve their smoking-related practices • States with multilevel programs have observed increased rates of smoking cessation among certain populations • Improved access to insurance increases access to smoking cessation services • Intervention research • Community trials • Program evaluation • Policy research • Epidemiology • Meta-analyses 5.What is the impact? • Significant declines in smoking-related diseases have occurred following the passage of laws to raise the price of cigarettes • Health services research • Surveillance research • Policy research   SOURCE: Adapted from Hiatt and Rimer (1999) and the Advisory Committee on Cancer Control, National Cancer Institute of Canada (1994). interdisciplinary nature. For the purposes of this report, the Board chose to focus on research that improves understanding of how to implement and disseminate interventions known to be effective. Such applied or translational research builds on epidemiological research, surveillance research, and the conduct of community trials and program evaluations. Such research focuses on questions posed in steps three and four of the stages of inquiry described in Table 10.1. STATUS OF TRANSLATIONAL RESEARCH IN CANCER PREVENTION AND EARLY DETECTION This section first describes publication trends in cancer prevention and early detection and then summarizes the support for such research provided by the following organizations:

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Fulfilling the Potential of Cancer Prevention and Early Detection Federally Sponsored Research U.S. Department of Health and Human Services National Institutes of Health (National Cancer Institute, National Institute on Aging) Centers for Disease Control and Prevention Agency for Healthcare Research and Quality Centers for Medicare and Medicaid Services (formerly the Health Care Financing Administration) U.S. Department of Defense U.S. Department of Veterans Affairs Privately Sponsored Research American Cancer Society Foundations (e.g., Robert Wood Johnson Foundation and the Legacy Foundation) Although these organizations are not the only sponsors of research on cancer prevention and early detection, they represent the major funding sources for such research. Excluded from this review are health services research supported by health plans, insurers, pharmaceutical companies, and other private organizations. Much of the research done in those settings is proprietary. Publication Trends The evaluation of trends in research publications is one way to assess the level of activity within a discipline. A resource that can be used to track such studies is the National Library of Medicine’s PubMed database, which stores information about individual citations including index terms used to characterize each article (articles are indexed according to a dictionary of medical subject headings called MESH terms). The PubMed database includes citations from MedLine, HealthStar, and other bibliographical databases. The volume of articles on cancer prevention and control appears to have increased markedly from 1985 to 2000, from 548 to 2,193 (Figure 10.1). Although the number of research citations on cancer prevention and control increased during this period, by 2000 they represented less than 5 percent of all cancer-related citations indexed in the medical literature (Figure 10.2). These trends reflect articles written in the English language, but not necessarily by U.S. investigators. Figures 10.1 and 10.2 therefore reflect trends in the general medical literature, not necessarily trends in the United States. These trends must be interpreted with caution because they may

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Fulfilling the Potential of Cancer Prevention and Early Detection FIGURE 10.1 PubMed citations for cancer-related prevention and control research, 1985–2000. FIGURE 10.2 PubMed citations for cancer-related prevention and control research as a percentage of all cancer-related citations, 1985–2000. reflect changes in the ways in which MESH headings were applied to index the literature rather than real increases in cancer-related research. The term “prevention and control,” the MESH subheading used to identify citations, refers to prevention and control of environmental hazards and social factors that lead to disease and preventive measures taken by individuals (National Library of Medicine, 2001).

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Fulfilling the Potential of Cancer Prevention and Early Detection Research Support A more direct way to assess the status of U.S.-based prevention and early detection research is to describe current topics of investigation and levels of research spending. No one comprehensive source of information on cancer prevention and early detection exists. As part of its review, the National Cancer Policy Board relied on the following sources: review of agency websites (e.g., those of the National Cancer Institute [NCI] and the U.S. Department of Defense); reviews of annual reports of the research arms of certain agencies (e.g., those of the U.S. Department of Veterans Affairs and the Health Care Financing Administration, now the Centers for Medicare and Medicaid [CMS]); informal contacts with agency representatives known to be involved in related research (e.g., those from CMS and U.S. Department of Veterans Affairs Centers of Excellence); meetings with senior agency representatives (e.g., those from NCI); information catalogued in the Health Services Research Project database, which is maintained by the National Library of Medicine and which includes brief descriptions of ongoing extramural research sponsored by federal and state agencies, foundations, and other organizations; the Research and Development in the United States (RADIUS) database maintained by the RAND Corporation; this database includes information on the research and development activities of the U.S. government, including activities indexed in the Computer Retrieval of Information on Scientific Projects database maintained by the National Institutes of Health (NIH; http://radius.rand.org). the Foundation Center’s online directory (www.fconline.fdncenter.org); publications of Grantmakers in Health (e.g., Prevention Strategies for All Ages: Findings from the Grantmakers in Health Resource Center) (Grantmakers in Health, 2000); and announcements of research support in prevention-related newsletters and listservs (e.g., Health Behavior Information Transfer and the Susan G. Komen Breast Cancer Foundation’s Newsletter). Despite the best efforts of the Board, the description of selected agencies’ research portfolios that follows may under- or overestimate the actual level of research. Organizations varied in how they defined cancer prevention and early detection, and consequently, there is likely some inconsistency in what was included (or excluded) as a relevant research activity. An attempt was made to limit the search to applied or translational research, but it was not always possible to distinguish projects that fit this description. Furthermore, some research activities may have been missed because of limitations of research tracking systems. This review is limited to sources

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Fulfilling the Potential of Cancer Prevention and Early Detection of research support that are national in scope; however, the Board recognizes that there are many significant sources of support for cancer prevention-related research at the state and regional levels (e.g., the California Department of Health Services, the California HealthCare Foundation, the Colorado Trust, the Kansas Health Foundation, and the Paso del Norte Health Foundation). The review was conducted in 2001 and is limited, for most organizations, to research projects active at that time. Federally Sponsored Research U.S. Department of Health and Human Services National Institutes of Health, National Cancer Institute NCI spent 12 percent of its fiscal year (FY) 2001 operating budget on cancer control ($459.5 million of $3.7 billion) (Stacey Vandor, Planning Officer, Office of the Director, Division of Cancer Control and Population Sciences, National Cancer Institute, personal communication to Maria Hewitt, Institute of Medicine, February 11, 2002). The U.S. Congress directed NCI to appropriate 10 percent of its budget to its Cancer Prevention and Control Program in the Revitalization Act of 1993 (National Institutes of Health, 1998). NCI supports a large portfolio of basic and applied research. In FY 2001, for example, NCI let 510 grants and contracts for basic and applied research related to tobacco totaling $128 million. Behavioral research grants and contracts on obesity and physical activity totaled over $25 million and there were 37 grants totaling $15 million in the Behavioral Research Applied Cancer Screening grants portfolio. Listed below are selected NCI-supported grants that represent applied or translational research active in 1999 according to the RADIUS database.1 Tobacco Enhanced self-help interventions for smoking cessation Individualized relapse prevention among female smokers Accelerating progress of smoking cessation during pregnancy A new channel for smoking cessation: visiting nurses Nicotine patch and self-help treatment for those who use smokeless tobacco Interventions targeting tobacco use 1   This list of NCI-supported research is meant to provide examples of grant support to illustrate the breadth and scope of applied research. The list may not be complete because of limitations to the search of the RADIUS database for relevant research. Keywords used in the search included “human,” “cancer,” “smoking” or “tobacco,” “diet” or “nutrition,” “physical activity,” “obesity,” “screening,” and “prevention and control.”

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Fulfilling the Potential of Cancer Prevention and Early Detection Smoking cessation among childhood cancer survivors Spousal influence on tobacco use after cancer diagnosis Smoking cessation outcomes in individuals on methadone maintenance Tobacco use prevention multimedia system for children (application of CD-ROM and World Wide Web lessons and activities on tobacco use prevention) Tobacco advocacy at the state level (case studies of activities of the tobacco industry and tobacco control advocates). Diet and Nutrition Five-a-Day Power Plus Program (assessment of a school cafeteria-focused intervention for promoting increased consumption of vegetables and fruit among elementary school children to reduce the risk of cancer) Five-a-Day achievement badge for urban Boy Scouts (intervention to increase fruit and vegetable consumption among youth) Five-a-Day WIC promotion program (intervention to improve consumption of fruits and vegetables among participants of the Special Supplemental Nutrition Program for Women, Infants, and Children [WIC] in Maryland) Goal setting for health-related behavioral changes among children (intervention to improve consumption of fruits and vegetables) Reducing cancer-related dietary risk behaviors in adolescents (school-based program targeting multiethnic students from families of lower socioeconomic status, their families, and their school environment to increase student consumption of fruits and vegetables and to reduce their intake of total calories from fat) Reaching rural residents with nutrition strategies. Obesity, Physical Activity Cancer risk factor prevention for high-risk youth (focus on diet, physical activity, and obesity among Hispanic Americans) Fitness as a means of fighting cancer among African-American women Weight control to prevent cancer in African-American women. Screening Increasing use of mammography among older, minority, and rural women Increasing use of screening mammography through urban churches Breast cancer screening in a triracial rural population Reducing barriers to the use of breast cancer screening Screening of older minority women

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Fulfilling the Potential of Cancer Prevention and Early Detection Population-based approach to increased mammography use Interactive multimedia to promote breast cancer screening Multimedia breast cancer education kiosks for Latinos Breast cancer risk and symptom care in African-American women ages 40 to 49 Breast and cervical cancer screening among Filipino women Promotion of breast cancer screening among indigent women Cancer screening of low-income and minority women Increasing adherence to follow-up of breast abnormalities Single-visit cervical cancer prevention program Intergroup cancer prevention research units: screening of first-degree relatives for colorectal cancer Informed decision making in prostate cancer screening (test methods of unbiased patient education). Community-Based Interventions Accelerating the process of change for cancer prevention (evaluation of multiple intervention channels to enhance cancer prevention and control) Northern Appalachian Leadership Initiative on Cancer (development of community-based coalitions to develop, implement, maintain, and evaluate long-range, comprehensive, multidisciplinary, and community-wide projects in West Virginia, Pennsylvania, New York, Ohio, Maryland, and Virginia) Tristate Appalachian Leadership Initiative on Cancer (consortium of cooperative extension services, universities, and a hospital system in North Carolina, South Carolina, and Georgia to create a network of community cancer control coalitions, mobilize community lay and professional leaders, develop and disseminate cancer control interventions, and evaluate the effectiveness of the initiative) County-based cancer control in northern Appalachia (consortium development in Pennsylvania, Maryland, and New York) Central highlands Appalachian Leadership Initiative on Cancer (consortium development in Kentucky, Tennessee, and Virginia) Capacity building for public education (effort to transfer cancer education and prevention information and educational skills from health professionals to community-based lay health promoters and successor groups) Community outreach model for cancer control (community analysis and implementation of an educational program by a comprehensive cancer center) Worksite-based cancer prevention (Wellworks-2) Worksite-based smokeless tobacco-related behaviors.

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Fulfilling the Potential of Cancer Prevention and Early Detection Provider Practices Female physicians health study—cancer prevention (examines whether physicians’ personal health practices help predict their counseling behaviors) Cancer prevention in primary care—patient activation (randomized, controlled trial to test the efficacies of two computer-tailored, stage-based interventions to address multiple cancer risk behaviors and screening use) Cancer prevention in primary care—practice activation (quasi-experimental study of 68 primary care practices in two cities in North Carolina to evaluate an office system for cancer prevention) New health assessment methods for cancer prevention (assessment of a dissemination model termed “physician-directed, customized delivery”) Breast cancer education in north Manhattan (focus on physicians through “academic detailing” and patients through office-based health educators) Direct observation of primary care-cancer prevention trial (focus on increasing rates of adherence to prevention guidelines) Patient-focused cancer control in a health maintenance organization (HMO) population Promoting cancer prevention and control with message framing (evaluation of methods to convey health information in terms of individual gains and losses). Special Populations Colorectal disease prevention in multiethnic populations Cancer prevention for the underserved (training home attendant as a community educator) Economically disadvantaged youth and cancer prevention Cancer prevention in rural youth—teaching health goals Preventing cancer in Hispanic communities (5-year program to establish and maintain the National Hispanic Leadership Initiative on Cancer). Reducing cancer risk in migrant Hispanic adolescents Community-based randomized trial of cancer prevention in the Hispanic population Community-based outreach for high-risk Mexican-American women (focus on cervical cancer screening, safe sex practices, and smoking) Por la Vida intervention model in cancer education (focus on community-based health promotion among Hispanics) National African-American Leadership Initiative on Cancer (development and support of community coalitions in the African-American community)

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Fulfilling the Potential of Cancer Prevention and Early Detection Improving cancer risk communication (focus on risk perception and interventions to improve decision making among African Americans and women in their 50s and 60s regarding smoking and mammography use) Cultural methods to decrease cancer fatalism among African-American elders Network radio health care program for African Americans (development of a talk show to deliver cancer prevention and control information and offer opportunities to call in with questions). Cancer control in North American Chinese women (focus on cervical cancer screening and dietary behavior) Cervical cancer control in a Cambodian population (focus on cervical cancer screening) Cancer control needs among Native American Samoans Health promotion for women at risk for breast cancer. NCI’s Division of Cancer Control and Population Sciences (DCCPS) is the main locus for NCI-sponsored applied cancer prevention and early detection research. The five major research areas overseen by DCCPS include epidemiology and genetics research, behavioral research, applied research, cancer surveillance research, and survivorship research (Figure 10.3) (http://cancercontrol.cancer.gov). Through its research activities, the DCCPS aims to understand the causes and distribution of cancer in populations, support the development and implementation of effective interventions, and monitor and explain cancer trends in all segments of the population. Cancer control research is also supported through other areas of NCI including the Division of Cancer Prevention and the Center to Reduce Cancer Health Disparities. In addition, the Cancer Information Service, an important dissemination arm, is housed within the Office of Communications (see Chapter 9). In FY 2001, DCCPS funded 733 research grants totaling $332.7 million. The areas receiving the most support were epidemiology and genetics (54 percent, or $180.3 million) and behavioral research (34 percent, or $113.5 million) (Table 10.2). Within the behavioral research portfolio, tobacco control research received 47 percent of the total amount of funding devoted to research ($52.9 million of $113.5 million) (Figure 10.4). NCI supports several priority areas of prevention and early detection research including tobacco, cancer communications, health disparities, quality of care, and dissemination and diffusion. Tobacco-Related Research. In its plan and budget proposal for 2003, research on tobacco use and tobacco-related cancers and cancer communication were identified as “extraordinary opportunities for investment”

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Fulfilling the Potential of Cancer Prevention and Early Detection Survey of colorectal cancer screening practices in health care organizations ($816,642, September 1998–July 2001) Medicare quality monitoring system (measuring the effectiveness of peer review organizations’ Health Care Quality Improvement Project that includes activities focused on breast cancer) ($1,173,065, September 2000– January 2001) Provision of early and periodic screening, diagnosis, and treatment services in state Medicaid plans and Medicaid managed care contracts ($49,241, August 1999–January 2001) Utilization of health care services related to cancer prevention for women in the Medicaid program ($233,440, September 2000–September 2001) Mauli Ola (Spirit of Life) Project, an outreach and preventive health demonstration project targeted to native Hawaiians ($704,055, September 2000–September 2005) Community health advocate program, which uses lay health workers to reach vulnerable populations (general focus, not specific to cancer) ($500,000, August 2000–July 2002) Health Promotion in the African-American Community, a computer-based nutrition program ($120,754, September 2000–September 2001) Increasing breast cancer screening in African-American women, a community pilot project ($124,990, September 2000–September 2001) Cervical and breast cancer screening for post-reproductive-age Hispanic women residing near the U.S.-Mexico border ($263,281, September 2000–September 2001) A systematic approach to improving Pap smear screening rates among Hispanic and Latino women in managed Medicaid systems ($124,450, September 2000–September 2001) As part of CMS’s Healthy Aging Initiative, a literature review has been completed of the evidence of the effectiveness of prevention services (e.g., screening and smoking cessation programs) in the Medicare population. In addition, a demonstration program is in progress to test the effects of various benefit enhancements on smoking cessation. The three benefit options being compared with usual care (smoking cessation information) in the seven-state Medicare Stop Smoking Program are (www.hcfa.gov/healthyaging/1b.htm): reimbursement for provider counseling only, reimbursement for provider counseling and Food and Drug Administration-approved prescription or nicotine replacement pharmacotherapy, and a telephone counseling quit line and reimbursement for nicotine replacement therapy.

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Fulfilling the Potential of Cancer Prevention and Early Detection The program began in 2001 and is expected to be completed in 2003. Much of CMS’s quality improvement work is carried out by its national network of 53 Quality Improvement Organizations (see Chapter 9 for a description of efforts to improve the use of mammography screening). U.S. Department of Defense The U.S. Department of Defense (DoD) administers extramural grant programs for research related to cancer of the breast, prostate, and ovary through the U.S. Army Medical Research and Materiel Command office of the Congressionally Directed Medical Research Programs (CDMRP) (Table 10.5). CDMRP strives to identify gaps in funding and provide award opportunities that will enhance program research objectives without duplicating existing funding opportunities. Funding is available for research, infrastructure, and training. A Special Populations Program was established in FY 1998 to help boost the participation of minority scientists and to support research on health disparities within the other programs of CDMRP. Very few awards available through CDMRP support prevention-related translational research. In FYs 1999 and 2000, 5 of 584 research awards were for breast cancer-related health services research (http://cdmrp.army.mil): factors affecting African-American women’s participation in screening, remote patient management for screening mammography in underserved areas, screening of older, disadvantaged women, mammography follow-up of women ages 40 to 49, and exercise and breast cancer prevention. TABLE 10.5 Congressionally Directed Medical Research Programs of the U.S. Department of Defense   Appropriations (in millions of dollars)a Number of Awards Research Area Pre-FY 2000b   Pre-FY 2000b   Breast cancer $1,043 $174 2,290 553 Prostate cancer $210 $100 297 140 Issues pertinent to military forces $44.5 $50.0 16 14 aAdditional funds ($3.1 million as of FY 2001) are available for breast cancer research through the sales of the breast cancer postage stamp. bFunding for prostate cancer research began in 1997. Funding for the Peer-Reviewed Medical Research Program to promote research on issues pertinent to the military forces began in 1999. SOURCE: http://cdmrp.army.mil.

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Fulfilling the Potential of Cancer Prevention and Early Detection In FYs 1999 and 2000, 6 of 185 research awards were for prostate cancer-related health services research (http://cdmrp.army.mil): screening among African-American men, informed consent for prostate-specific antigen testing, utility assessment for prostate cancer screening among African-American men, tracking system to improve screening and follow-up, changing attitudes and behaviors of African-American men for screening for prostate cancer, and pharmacists as health educators and risk communicators in the prevention of prostate cancer. Smoking cessation is 1 of 18 prioritized areas of the DoD Peer-Reviewed Medical Research Program, but only one award for smoking cessation research has been made since the program’s inception in 1999. The funded program aimed to develop a model DoD smoking cessation program. U.S. Department of Veterans Affairs The U.S. Department of Veterans Affairs (VA) Office of Research and Development had a FY 2001 budget of $351 million and supports intramural biomedical, rehabilitation, and health services research (Veterans Administration, Office of Research and Development, 2000). Health services research focuses on conditions that are common among veterans, including cancer (especially prostate and lung cancer). Much of the VA’s health services research is carried out in its 12 Centers of Excellence. Each center was contacted regarding its cancer prevention and early detection research. Table 10.6 describes the VA-funded prevention research carried out at some of these centers. In 1998, the VA launched its Quality Enhancement Research Initiative (QUERI) to provide a systematic approach to quality improvement. Eight clinical areas were initially targeted that were of particular significance to veterans (i.e., chronic heart failure, diabetes, human immunodeficiency virus infection and AIDS, ischemic heart disease, mental health, spinal cord injury, stroke, and substance abuse), and subsequently, health services research was funded in these areas (Veterans Administration Office of Research and Development, Health Services Research and Development Service, 2000). In 2001, a Cancer QUERI Center was established with support from NCI (Veterans Administration Office of Research and Development, Health Services Research and Development Service, 2001). The VA’s Cooperative Studies Program (CSP) is a large multicenter clinical trial program that determines the effectiveness of interventions. A

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Fulfilling the Potential of Cancer Prevention and Early Detection TABLE 10.6 VA-Supported Cancer Prevention and Early Detection Research at VA Centers of Excellence VA Center of Excellence Research Activity in Prevention and Early Detection 1.Center for Health Services Research • Cost utility analysis of alternative in Primary Care strategies for screening for colorectal cancer • Identification of factors prognostic of late-stage disease, particularly those that are modifiable 2.Center for the Study of Health Disparities • Barriers and facilitators for colorectal cancer screening in VA and non-VA settings 3. Center for the Study of Health Care • Smoking cessation, prevention in the Provider Behavior elderly, exercise 4. Houston Center for Quality of Care and Utilization Studies • Barriers to colorectal screening • Hepatitis C screening and surveillance patterns recent CSP trial demonstrated that colonoscopy may be the best method of screening for colon cancer for asymptomatic individuals. Privately Sponsored Research American Cancer Society The American Cancer Society (ACS) is the largest private, not-for-profit source of funds for cancer research in the United States ($97.3 million in FY 1999–2000) (www2.cancer.org). ACS focuses its research spending on beginning investigators and a program of targeted research, and in recent years it has enhanced its commitment to psychosocial and behavioral, health services, health policy, epidemiological, clinical, and cancer control research. In response to identified needs in clinical oncology, ACS also sponsors grants in support of training for health care professionals seeking to develop their clinical expertise or their ability to conduct independent research. (Training and educational support are described in Chapter 8.) ACS prioritizes investigator-initiated proposals and funds proposals by a peer-review process. In FYs 1999 to 2000, relatively little ACS research funding was devoted to prevention (14 percent) and detection (15 percent) relative to that devoted to the causes or etiology of cancer (70 percent) or cancer treatment (33 percent) (Table 10.7).

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Fulfilling the Potential of Cancer Prevention and Early Detection TABLE 10.7 ACS Research Funding (Intramural and Extramural), FYs 1999 to 2000 Area of Research Amount Awarded (dollars) Percentage of Totala Total $97,299,000 100 Prevention 13,675,000 14 Detection 14,272,000 15 Treatment 31,784,000 33 Causes and etiology 68,411,000 70 Psychosocial and behavioral 11,473,000 12 Poor and underserved populations 7,711,000 8 aCategories are not mutually exclusive (e.g., a grant that is related to both prevention and detection is counted twice). Dollar amounts are rounded off to the nearest $1,000. SOURCE: www2.cancer.org. Robert Wood Johnson Foundation As part of its philanthropic activities the Robert Wood Johnson Foundation (RWJF) has prioritized reducing the harm caused by substance abuse including tobacco, alcohol, and illicit drugs. In 2000, RWJF provided $83.4 million in support for initiatives related to that priority, with roughly $33 million in support provided for smoking and tobacco use cessation-related research (Julie Painter, proposal management associate, RWJF, personal communication to Maria Hewitt, Institute of Medicine, July 7, 2001). The following were among the projects related to smoking and tobacco use control funded by RWJF(www.rwjf.org): Addressing Tobacco in Managed Care is a program that promotes the integration of effective smoking cessation interventions into the basic health care provided by managed care organizations. RWJF makes available grants for studies that evaluate the effectiveness of replicable organizational strategies that lead health care providers, practices, and plans to adopt and adhere to the recommendations of the AHCPR Smoking Cessation Clinical Practice Guideline. Projects funded under this initiative examine the impacts of organizational strategies (including clinical, financial, and administrative practices) on such outcomes as smoker identification, tobacco use reduction among patients, rates of clinician intervention, and costs of intervention efforts. National Center for Tobacco-Free Kids is a program that supports a national campaign to reduce youth tobacco use through the establishment of a center that develops a national strategy, serves as a media center, provides technical assistance, and broadens organizational support to reduce youth tobacco use.

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Fulfilling the Potential of Cancer Prevention and Early Detection Partners with Tobacco Use Research Centers, Advancing Transdisciplinary Science and Policy Studies, provides support for an NCI-National Institute on Drug Abuse program to apply and integrate advances in molecular biology, neuroscience, genetics, and behavioral science to the challenge of tobacco use control. RWJF funds dissemination and policy research and analysis efforts and supports efforts to communicate scientific breakthroughs in language that policy makers, the public, and the media can understand. Research Network on the Etiology of Tobacco Dependence is a program that brings together leading researchers from a variety of perspectives and disciplines to work collaboratively in the study of the etiology of tobacco dependence. Smoke-Free Families: Innovations to Stop Smoking During and Beyond Pregnancy uses a multicomponent strategy to improve current clinical practice and advance the smoking and tobacco use cessation field into the next generation of smoking cessation techniques for childbearing women. Smokeless States: National Tobacco Policy Initiative is a program that supports the development and implementation of comprehensive statewide strategies to reduce tobacco use through education, treatment, and policy initiatives. The American Legacy Foundation The American Legacy Foundation is a national, independent, public health foundation established to reduce tobacco use in the United States (www.americanlegacy.org). The Foundation is supported with funds from tobacco manufacturers as dictated by the 1998 Tobacco Master Settlement Agreement. Through this agreement, a coalition of 46 state attorneys general successfully reached agreement with tobacco companies, which will pay $206 billion over 25 years. As outlined in the 1998 Tobacco Master Settlement Agreement, the Foundation supports educational programs and research to (1) reduce tobacco product use by youth and (2) prevent diseases associated with the use of tobacco products. In early December 2001, Legacy launched its “Great Start” educational, counseling and marketing campaign to help pregnant women quit smoking. The foundation has budgeted $7.5 million to run and promote this initiative. American Legacy Foundation funds a national grants program with an annual budget of approximately $30 million which provides support for state and local tobacco use prevention, education, and cessation programs and provides small grants to fund innovative approaches and programs to reduce or eliminate tobacco use. Legacy is addressing disparities in access to tobacco cessation and prevention service among various ethnic and cultural groups through its Priority Populations Initiative. This program is providing $21 million over three years to support capacity-

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Fulfilling the Potential of Cancer Prevention and Early Detection building grants, innovative projects, and applied research grants. Legacy has also provided over $200 million over the last two years to support a major tobacco use prevention and education advertising campaign targeted at young people, called truthsm (Christine Fritz, Accounting Manager, American Legacy Foundation, personal communication to Maria Hewitt, Institute of Medicine, February 11, 2002). Several other selected large foundations support cancer prevention and early detection research and dissemination activities (Table 10.8). The Cochrane Collaboration The Cochrane Collaboration is an international nonprofit organization that “aims to help people make informed decisions about health care, by reviewing and promoting the best available evidence on the effects of interventions and treatments” (www.cochraneconsumer.com). Review groups, organized by area of health care (e.g., breast cancer and tobacco addiction), conduct systematic reviews of evidence, emphasizing results from published TABLE 10.8 Other Selected Foundations Supporting Cancer Prevention and Early Detection Research Foundationa Total Amount Given (dollars) Priority Area(s) Type of Support American Institute for Cancer Research $4,924,212 Diet, nutrition, and cancer Collaborative research grants, investigator-initiated grants, matching grants, postdoctoral grant awards Federated Department Stores Foundation 11,513,341 Breast cancer Local agency support to develop projects that affect their communities General Mills Foundation 15,009,937 Health and nutrition Promotion of healthy lifestyles in underserved communities Susan G. Komen Breast Cancer Foundation 23,497,426 Breast cancer Basic, clinical, and translational research; fellowships; professorships Metropolitan Life Foundation 13,186,931 Health education National programs aimed at youth Robertson Foundation 5,410,959 Cancer Organizational unrestricted support aThe foundations listed are those included in the Foundation Center database that (1) gave total amounts in excess of $4 million in the most recent year for which data were available, (2) listed a focus on cancer prevention or a cancer-related risk factor (e.g., diet, nutrition, or smoking), and (3) did not restrict their support to one or a few local areas or states. SOURCE: Foundation Center, www.fconline.fdncenter.org, accessed May 2001.

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Fulfilling the Potential of Cancer Prevention and Early Detection and unpublished randomized clinical trials. Available evidence is reviewed systematically (www.canet.org/rationale.htm) by: using an explicit, detailed search strategy to find as many reports of relevant trials as possible; carrying out the review according to a written protocol; using explicit prespecified inclusion and exclusion criteria; using standard methods to assess trial quality; employing two people to independently extract the data; analyzing by synthesis of the actual numerical results, where possible (a technique known as meta-analysis); and presenting the review in a detailed, clear, and transparent fashion so that readers can see how conclusions were reached. Since 1996, the Cochrane Cancer Network (www.canet.org) has coordinated the work of cancer site-specific groups. Systematic reviews included in the Cochrane Library and relevant to cancer prevention and early detection are listed in Box 10.3. The Cochrane Cancer Network is developing a specialized database for cancer, the Cancer Library, which will serve as a comprehensive source of information about cancer for consumer groups and other members of the cancer community (www.update-software.com/cancer/about-cancer.html). Translational Research Models A hallmark of translational cancer prevention and control research is its interdisciplinary nature and potential for broad application to the practices of individuals, clinicians, educators, social service providers, and community-based programs. An ideal research program would therefore reflect this wide scope and crosscutting nature of the practice of cancer prevention and early detection. Collaborative and interdisciplinary research are supported by several mechanisms. Transdisciplinary Tobacco Use Research Centers (TTURCs), for example, jointly sponsored by NCI and the National Institute on Drug Abuse, involve researchers with a wide range of perspectives to aid further understanding of tobacco use and nicotine addiction. These novel centers are designed to bridge disciplinary barriers, establish new conceptual frameworks and methods to understand and treat tobacco use, speed the transfer of innovative approaches to communities nationwide, and create a core of new tobacco control researchers (http://www.partnerstturc.com). The affiliated Partners program is funded by the Robert Wood Johnson Foundation to support tobacco-related policy research and communications activities at the funded TTURCs (http://www.partnerstturc.com/overview/index.htm).

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Fulfilling the Potential of Cancer Prevention and Early Detection BOX 10.3 Cochrane Reviews Related to Cancer Prevention and Early Detection Breast cancer Strategies for increasing participation of women in community breast cancer screening Screening for breast cancer with mammography Colorectal cancer Screening for colorectal cancer by the fecal occult blood test (Hemoccult) Gynecological cancer Interventions for encouraging sexual lifestyles and behaviors intended to prevent cervical cancer Tobacco addiction Acupuncture for smoking cessation Antidepressants for smoking cessation Anxiolytics for smoking cessation Aversive smoking therapy for smoking cessation Clonidine for smoking cessation Community interventions for prevention of smoking in young people Exercise interventions for smoking cessation Group behavior therapy programs for smoking cessation Hypnotherapy for smoking cessation Individual behavioral counseling for smoking cessation Interventions for prevention of smoking in public places Interventions for prevention of tobacco sales to minors Interventions for smoking cessation in hospitalized patients Lobeline for smoking cessation Mass media interventions for prevention of smoking in young people Mecamylamine (a nicotine antagonist) for smoking cessation Nicotine replacement therapy for smoking cessation Nursing interventions for smoking cessation Physician advice for smoking cessation Self-help interventions for smoking cessation Silver acetate for smoking cessation Telephone counseling for smoking cessation Training health professionals in smoking cessation SOURCE: www.update-software.com, accessed June 28, 2001. Other interesting models for the conduct of translational research can be found in the areas of diabetes and mental health. Translational research for the prevention and control of diabetes is being supported through a public-private collaboration of the National Institute of Diabetes and Digestive and Kidney Diseases, the National Eye Institute, the National Institute of Nursing Research, and the American Diabetes Association (http://grants.nih.gov/grants/guide/pa-files/PA-01-069.htm). The purpose of the

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Fulfilling the Potential of Cancer Prevention and Early Detection program is to learn more about how to translate recent advances in the prevention and treatment of diabetes into clinical practice for individuals and communities at risk. Targets for funding are studies that will develop and test improved methods of delivery of health care to patients with or at risk of diabetes as well as cost-effective community-based strategies to promote healthy lifestyles that will reduce the risk of diabetes and obesity. The program is based on the principle that strategies are needed to achieve objectives that have already been proved to be beneficial or to enhance behaviors that are expected to improve health outcomes. Of particular interest also are interventions that focus on the translation of new advances into practice for underserved and minority populations. Research is supported through the NIH research demonstration and dissemination project award mechanism (R18 grants). This mechanism is designed to support the testing and evaluation of interventions and activities that lead to the application of existing knowledge to disease control and prevention. Awards are made for up to 5 years. Translational Research Centers in Behavioral Science (TRCBSs) are being supported by the National Institute of Mental Health to “transcend the barriers of disciplines, research settings, and institutions in order to harness the full range of modern behavioral science to the service of the nation’s critical mental health needs” (http://grants.nih.gov/grants/guide/pa_files/PAR-01-027.html). A TRCBS is funded through the NIH Center Grant mechanism (P50 grants), which provides support for multidisciplinary and multi-investigator approaches to the investigation of specific and complex research problems requiring the application of diverse expertise and methodologies. Support is available for periods of up to 5 years, followed by a competitive renewal application for a second 5-year period. TRCBSs are expected to be organized around a specific and focused set of hypotheses, in which one or more areas of basic behavioral science are applied to clinical issues in mental disorders or mental health services delivery. SUMMARY The major government sponsors of cancer prevention and early detection translational research are the National Cancer Institute, the Agency for Healthcare Research and Quality, and the Centers for Disease Control and Prevention. Private sponsors making significant contributions to research include the ACS and, for smoking-related research, the Robert Wood Johnson Foundation and the American Legacy Foundation. When it could be ascertained, the share of total research spending devoted to cancer prevention and early detection is relatively low: 12 percent at the National Cancer Institute (this estimate includes the entire spectrum of cancer prevention and control), roughly 12 percent at the Centers

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Fulfilling the Potential of Cancer Prevention and Early Detection for Disease Control and Prevention ($500 million of $4,202 million),4 and 14 percent at the ACS. A very limited cancer prevention research portfolio exists within the U.S. Department of Defense’s Congressionally Directed Medical Research Programs. The spectrum of cancer prevention and research activity appears to be wide, but notably absent was much applied cancer-related research related to obesity and physical activity. More research in this area is needed in light of the emergence of an epidemic of obesity in the United States. Specific recommendations for research are outlined in Chapter 11. 4   This estimate includes the following chronic disease prevention and health promotion areas: cancer prevention and control; tobacco; nutrition, physical activity, and obesity; health promotion; and the youth media Campaign (see Table 10.3).