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8 Research T he National Cancer Policy Board, in an effort to understand how resources for research are applied to questions regarding psycho- social services for women with breast cancer, undertook a review of the status of research. Such a review provides only a snapshot as of 2003, but it does give an indication of the prominence and priority of psycho- social subjects as components within the field of breast cancer research, and a sense of the emphasis on different concerns and services within psycho- social breast cancer research. With these understandings, the Board was able to suggest ways in which a research program could be structured in the future to support better responses to psychosocial needs of women with breast cancer. This chapter first describes publication trends in breast cancer-related research and then summarizes major sources of support for research within the following organizations: Federally Sponsored Research Department of Health and Human Services National Institutes of Health (National Cancer Institute, National Institute of Nursing Research) Department of Defense Privately Sponsored Research American Cancer Society Foundations (e.g., Komen Foundation, Avon Foundation) 199
200 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER Although these organizations are not the only sponsors of breast can- cer-related psychosocial research, they represent the major funding sources for such research. Excluded from this review is research supported by health plans, insurers, pharmaceutical companies, and other private organizations. Much of the research in these settings is proprietary. The chapter concludes with the Boardâs identification of priority areas for research and recommen- dations to increase research opportunities. STATUS OF BREAST CANCER-RELATED RESEARCH Publications Evaluating trends in research publications is one way to assess the level of activity within a discipline. A resource for tracking such studies in the National Library of Medicine (NLM) Medline bibliographic database, which stores information about individual citations including index terms used to characterize each article (articles are indexed according to a dictio- nary of medical subject headings called MESH terms). The volume of breast cancer-related psychology research articles ap- pears to have almost tripled from 1990 to 2000 (from 150 to 431 citations), but throughout the period such articles represent a small fraction of breast cancer-related research, less than 7 percent according to Medline searches (Figures 8-1 and 8-2). These trends reflect publications in English, but not limited to articles written by United States investigators. Figures 8-1 and 8- 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 reflect changes in the way MESH headings are applied to index the literature rather than real increases in breast cancer-related psy- chological research. Research Support A more direct way to assess the status of United States-based breast cancer-related psychosocial research is to describe topics of investigation and levels of research spending. There is no one comprehensive source of information on research support; as part of its review, the Board relied on the following sources: â¢ Listings of research projects provided by some organizations (e.g., National Cancer Institute); â¢ The federal listing of research projects (CRISP); â¢ Review of agency web sites (e.g., Department of Defense); and
RESEARCH 201 Number of breast cancer-psychology-related citations 450 431 400 348 350 314 Number of citations 300 250 216 200 182 150 150 100 50 0 1990 1992 1994 1996 1998 2000 Year FIGURE 8-1 PubMed citations for breast cancer psychological research, 1990â2000. Citations were identified in the National Library of Medicinesâs PubMed database using the MESH term âbreast neoplasms,â and the MESH subheading âpsychology.â Only articles published in English are counted. â¢ Informal contacts with agency representatives known to be involved in research (e.g., foundations). Despite the best efforts of the Board, the description of the nationâs breast cancer-related psychosocial research portfolio that follows may under- or overestimate the actual level of research. Some research activities may have been missed because of limitations of research tracking systems. The review is limited to currently active research projects for most organizations. Federally Sponsored Research National Cancer Institute, Office of Cancer Survivorship The main locus of cancer-related psychosocial research support within the Department of Health and Human Services (DHHS) is the National Can- cer Institute (NCI). Table 8-1 describes the NCIâs overall budget request for 2004, which includes $46 million for cancer survivorship research as detailed in Table 8-2 (0.7 percent of the total FY 2004 budget request). Cancer survi-
202 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER Percent of breast cancer-related citations pertaining to psychology 7 6.3 5.9 6 5.6 5 4.4 4.5 4.1 Percentage 4 3 2 1 0 1990 1992 1994 1996 1998 2000 Year FIGURE 8-2 PubMed citations for psychology related breast cancer research as a percentage of all breast cancer-related research, 1990â2000. Percentages were calculated as the number of psychology-related breast cancer citations (as described in Figure 8-1) divided by the number of citations categorized under the MESH term âbreast neoplasms.â Only articles published in English are counted. vorship research has been designated by NCI as an âExtraordinary Opportu- nity for Investment.â A research initiative focused on long-term survivors was announced in 2003, providing $20 million to support awards for studies of individuals who are five years or more beyond cancer diagnosis (http:// grants1.nih.gov/grants/guide/rfa-files/RFA-CA-04-003.html, accessed April 14, 2003). NCIâs work on survivorship is administered through its Office of Cancer Survivorship (OCS), which was established in 1996 to promote research and to provide information to cancer patients, their families, health-care provid- ers, advocates, and the research community (http://dccps.nci.nih.gov/ocs/, accessed April 18, 2003). OCS grants relating to breast cancer are shown in Table 8-3. About half of these are on psychosocial or quality of life subjects. National Cancer Institute, Office of Behavioral Research Psychosocial research is also supported through the NCIâs Office of Behavioral Research (BRP). Research supported in this office ranges from basic behavioral research to research on the development, testing and dis-
RESEARCH 203 TABLE 8-1 NCIâs Budget Request for Fiscal Year 2004 (in thousands) Fiscal Year 2003 Presidentâs Budget $ 4,637,869 Increase to core budget 294,014 Capacity building increase Enhancing investigator-initiated research 69,887 Expanding the capacity of centers, networks, and consortia 79,530 National clinical trials program in treatment and prevention 340,100 Developing bioinformatics for cancer research 88,000 Subtotal capacity building 577,517 Discovery and application increase Genes and the environment 51,800 Signatures of the cancer cell and its microenvironment 41,200 Molecular targets of prevention and treatment 54,800 Cancer imaging and molecular sensing 78,700 Cancer communications 39,750 Subtotal discovery and application 266,250 Public health emphasis increase Improving the quality of cancer care 27,000 Reducing cancer-related health disparities 61,350 Cancer survivorship 46,000 Research on tobacco and tobacco-related cancers 76,000 Subtotal public-health emphasis 210,350 Total FY 2004 budget request 5,986,000 SOURCE: The Nationâs Investment in Cancer Research: A Plan and Budget Proposal for Fiscal Year 2004, Prepared by the Director of the National Cancer Institute. semination of disease prevention and health promotion interventions in ar- eas such as tobacco use, screening, dietary behavior and sun protection. The BRP programs support five areas (http://www.dccps.nci.nih.gov/brp/ index.html): â¢ Applied Cancer Screening Research. Facilitates and supports effec- tiveness trials and related social and behavioral research to promote the use of effective cancer screening tests, as well as strategies for informed decision making regarding all cancer screening technologies, in both community and clinical practice. â¢ Basic Biobehavioral Research. To serve as a national model for pro- moting, sponsoring, and supporting basic biobehavioral research and training. â¢ Health Communication and Informatics Research. To advance com- munication and information science across the cancer continuumâpreven- tion, detection, treatment, control, survivorship, and end of life. Communi- cation and information science systematically examines the fundamental processes and effects of human and mediated communication. â¢ Health Promotion Research. Coordinates research on non-tobacco behavioral prevention of cancer in the areas of diet, physical activity, en- ergy balance, virus exposure, and sun exposure.
204 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER TABLE 8-2 Cancer Survivorship Component of NCIâs Budget Request for Fiscal Year 2004 (in millions) Researchâbiological, physical, psychological, and social response to $9.50 disease, treatment and recovery Physiologic and psychosocial effects on post-treatment survivors 3.00 Late effects case studies 5.00 Socio-cultural, behavioral, emotional, and spiritual factors 1.50 Intervention researchâto reduce cancer-related late morbidity and mortality 12.00 Research of cost-effective medical, educational, and psychosocial interventions 9.00 Development of interventions for families, minorities, and medically 3.00 underserved Development of assessment tools for quality of life and post-treatment care 5.50 New instruments for quality of life assessment (e.g., toxicity criteria for 2.00 late effects) Screening tools for high risk physical, psychosocial, or behavioral outcomes 2.00 Use of applied/theoretical statistics to establish criteria for clinically significant 0.50 changes Collaboration with other NIH institutes to develop measures to evaluate co- 1.00 morbidities Enhance NCIâs capacity to track outcomes for cancer survivors 5.50 Expansion of data collection on health-related outcomes for survivors in SEER 1.00 registries Development of infrastructure for clinical trials groups to follow patients long-term 2.00 Establishment of separate registry for pediatric cancer survivors 2.50 Development and dissemination of new interventions and best practice guidelines 3.50 Best practice guidelines for follow-up care and surveillance for survivors 1.25 Support studies to test adoption and impact of best practices in post-treatment care 1.50 Develop/disseminate curricula and standards for delivery of effective 0.75 psychosocial care Expansion of scientific base for understanding the biologic mechanisms in 9.00 adverse late effects Funding of pre-clinical studies examining incidence/mechanism of late effects 3.00 treatment Support research that seeks to investigate the neuropsychologic impact of cancer 6.00 therapy Management and support 1.00 Total 46.00 SOURCE: The Nationâs Investment in Cancer Research: A Plan and Budget Proposal for Fiscal Year 2004, Prepared by the Director of the National Cancer Institute. â¢ Tobacco Control Research. To reduce cancer incidence and mortal- ity caused by tobacco use through a comprehensive research program. To provide recommendations to the scientific and public health communities by synthesizing and disseminating research findings. A selection of some of the grants from this office that have focused on psychosocial research is displayed in Table 8-4.
RESEARCH 205 TABLE 8-3 Selected Current Breast Cancer-Related Survivorship Research, Office of Cancer Survivorship, NCI â¢ Facilitating positive adaptation to breast cancer â¢ Center for psycho-oncology research â¢ Breast cancer survivors, physical activity, and quality of life â¢ Bone marrow transplant (BMT) survivors study â¢ Young breast cancer survivorsâpopulation based cohort â¢ Quality of life in adult cancer survivors â¢ Menopausal symptom relief for women with breast cancer â¢ Breast cancer and function in aging women â¢ Quality of life of older long-term cancer survivors â¢ Quality of life intervention in breast cancer survivors â¢ Insomnia intervention for breast cancer survivors â¢ Psychological well being in long-term cancer survivors â¢ African American breast cancer survivor quality of life â¢ Characteristics of long-term breast cancer survivors â¢ Adjustment to breast cancer â¢ Home-based moderate exercise for breast cancer patients â¢ The economic consequences of cancer survival â¢ Breast cancer treatment outcomes in older women â¢ Psychosocial treatment effects on cancer survival â¢ Return to work in cancer survivors: A pilot study â¢ Enhancing long-term survival after BMT â¢ Biobehavioral and supportive needs during high dose TMT â¢ Enhancing recovery from blood and marrow transplantation â¢ Cognitive effects of breast cancer treatment â¢ Impact of maternal breast cancer on children â¢ Quality of life and relationships after BMT SOURCE: http://dccps.nci.nih.gov/ocs/portfolio.asp, accessed April 18, 2003. Department of Defense Beginning in FY 1992, the U.S. Congress directed the Department of Defense (DoD) to manage several appropriations for an extramural grant program directed toward specific research initiatives. The United States Army Medical Research and Materiel Command (USAMRMC) established the office of the Congressionally Directed Medical Research Programs (CDMRP) to administer these funds. Between FY 1992 and 2003, $1.37 billion has been appropriated by Congress to DoD for research on breast cancer. In addition, $7.0 million was generated in sales of the U.S. Postal Serviceâs first-class stamp (Public Law 105-41, Stamp Out Breast Cancer Act [H.R. 1585]). The CDMRP strives to identify gaps in funding and pro- vide award opportunities that will enhance program research objectives without duplicating existing funding opportunities.
206 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER TABLE 8-4 Selected Grants from NCIâs Office of Behavioral Research, FY 2001 and 2002a Project Title Fatigue, Sleep and Circadian Rhythms in Breast Cancer Psychological Intervention for Women with Breast Cancer The End-of-Life Family Workshop Pain Assessment via Role-Play Internet Simulation Health Promotion for Women at Risk for Breast Cancer Breast Cancer Risk-Tailored Messages for More Women Self-Advocacy and Empowerment for People with Cancer We Can CopeâFamily Support When a Parent Has Cancer Vicarious Dissonance, Attitude Change & Identity Web-Based Support for Informal Caregivers in Cancer Culturally Targeted Health Information Network Spiritually-Based Breast Cancer Communication Cognitive Behavioral Aspects of Cancer Related Fatigue Breast Cancer Patients RelativesâResponse Over Time Interactive CD-ROM for Coping with Breast Cancer Quality of Life, Ethnicity, and Breast Cancer Survivors Hormones, Quality of Life & Breast Cancer Support Groups aThe list contains grants carried over from prior fiscal years (FY 2001 and prior) and new grants awarded in FY 2002. SOURCE: NCI website, accessed on 2/27/03: http://dccps.nci.nih.gov/brp/research.asp. The Breast Cancer Research Program (BCRP) has sponsored over 2,800 awards for peer-reviewed breast cancer research at the community, state, and national level (Table 8-4). The BCRP divides the awards into three categories: 1. research (basic and clinical), 2. infrastructure, and 3. training and recruitment. In addition, an Innovator Award was initiated in FY01 that grants $5 million to individuals engaged in âvisionary research.â Within the BCRP, psychosocial research awards fall within the category of âBiobehavioral Sciences.â A total of 35 of the 105 biobehavioral awards of the BCRP per- tain to psychosocial issues (Table 8-5).
RESEARCH 207 TABLE 8-5 BCRP Study Awards with Psychosocial Component Name of Research Study Institution $ Amount Fiscal Year Evaluation of a Peer-Staffed Hotline for Univ. of $79,250.00 2000 Families Who Received Genetic Testing for Pennsylvania Risk of Breast Cancer Assisting Survivors in Meeting Challenges Univ. of $79,250.00 2000 at End of Treatment: A Problem Solving Pennsylvania Approach Hatha Yoga and Breast Cancer: Integrating a Columbia Univ. $81,725.00 2000 Mind/Body Intervention During Adjuvant Chemotherapy A Longitudinal Study of Emotional Distress Univ. of Hawaii $66,000.00 2000 and the Use of Complementary Alternative Medicine in Women with Breast Cancer Breast Cancer Protective Behaviors Among Florida State $22,000.00 2000 Low-income, Ethnically Diverse Women: Univ. The Role of Biopsychosocial Factors Spirituality-Based Intervention for African Wayne State $334,599.00 1999 American Women with Breast Cancer Univ. Interdisciplinary Research Training in Breast Yale Univ. $749,432.00 1999 Cancer Medical Decision-Making About Breast Univ. of Texas $73,513.00 1999 Cancer Among African Americans: at Houston Evaluating the Roles of Beliefs, Knowledge, Medical Care Access, and Social Support Internet Support and Information for Women Univ. of $61,519.00 1999 with Breast Cancer Alabama at Birmingham Stress and Immunity Breast Cancer Project Ohio State Univ. $808,568.00 1998 Identifying Quality of Life and Psychosocial UCLA $761,421.00 1998 Risk Factors and Their Sociocultural Mediators in African American, Filipino, Latino, and White Breast Cancer Survivors Postdoctoral Training Program in Mount-Sinai $782,413.00 1998 Biobehavioral Breast Cancer Research (NY) Psychological Distress, Cognitive Bias, and Mount Sinai $125,737.00 1998 Breast Cancer Surveillance Behavior in (NY) Women Tested for BRCA1/2 Mutation The Effect of Emotional Disclosure Virginia $44,622.00 1998 Interventions on Psychological and Physical Commonwealth Well-Being of Breast Cancer Patients University (continued)
208 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER TABLE 8-5 (Continued) Name of Research Study Institution $ Amount Fiscal Year The Development and Evaluation of an Stanford Univ. $327,015.00 1998 Innovative Internet-Based Breast Cancer Psychosocial Intervention Inherited Susceptibility to Breast Cancer in Sloan-Kettering $481,210.00 1997 Healthy Women: Mutations in Breast Cancer Genes, Immune Surveillance and Psychological Distress Psycho-Endocrine-Immune Profile: Loyola $325,626.00 1997 Implications for Quality of Life in Breast Universityâ Cancer Patients Chicago Development of an Integrated Program of Univ. of $227,876.00 1996 Health related Quality of Life Research for Pittsburgh the National Surgical Adjuvant Breast and Bowel Project (NSABP). Social Support and Endocrine Function: A Ohio State Univ. $82,932.00 1996 Randomized Trial with Breast Cancer Patients Preventive Psychosocial Intervention for Univ. of $292,243.00 1996 Young Women with Breast Cancer Pittsburgh Stress and Coping in Genetic Testing for Univ. of $837,296.00 1995 Cancer Risk Michigan Effects of Psychosocial Intervention in Univ. of $149,991.00 1995 Women Following Breast Cancer Diagnosis Rochester Delays and Refusals in Treatment for Breast Univ. of New $72,043.00 1995 Cancer among Native American and Mexico Hispanic Women with Breast Cancer Psychobehavioral Impact of Genetic Sloan-Kettering $579,581.00 1995 Counseling and Breast Cancer Gene Testing in Healthy Women of African Descent Psychological Intervention for Women with Ohio State Univ. $86,896.00 1993 & 94 Breast Cancer Enhancing Positive Reactions to Breast Hutchinson $597,673.00 1993 & 94 Cancer Risk Appraisal Cancer Center The Effects of a Comprehensive Coping Johns Hopkins $783,572.00 1993 & 94 Strategy on Clinical Outcomes in Breast Univ. Cancer Bone Marrow Transplant Patients and Primary Caregiver
RESEARCH 209 TABLE 8-5 (Continued) Name of Research Study Institution $ Amount Fiscal Year Effects of Meditation-Based Stress Univ. of $799,843.00 1993 & 94 Reduction in Younger Women with Breast Massachusetts Cancer Psycho Educational Group Intervention for Strang Cancer $799,837.00 1993 & 94 Women at Increased Risk for Breast Cancer Center The Effects of Brief Psychotherapy on North Dakota $143,510.00 1993 & 94 Coping with Breast Cancer State Univ. Incidence and Psychophysiology of Post- Harvard Univ. $724,375.00 1993 & 94 Traumatic Stress Disorder in Breast Cancer Victims and Witnesses Knowledge and Beliefs of Breast Cancer Univ. of Puerto $771,159.00 1993 & 94 Among Elderly Puerto Rican Women Rico An Evaluation of A Peer Support Program to Kaiser $595,732.00 1993 & 94 Improve Quality of Life with Breast Cancer Foundation Emotional Processing and Expression in Univ. of Kansas $145,839.00 1993 & 94 Breast Cancer Patients: Effects on Health and Psychological Adjustment A Community Study of Psychological Sloan-Kettering $200,000.00 1993 & 94 Distress and Immune Function in Women with Family Histories of Breast Cancer SOURCE: Department of Defense Breast Cancer Research Program: Search Awards Data- base, http:Hcdmrp.army.mil/cgi-bin/search/search-bcrp.pi, accessed November 21, 2002. Privately Funded Research Private philanthropic organizations have been major sponsors of breast cancer research. This section of the report reviews the research activity of the American Cancer Society, the Avon Foundation, the Susan G. Koman Foundation, and the Bristol Myers Squibb Foundation. American Cancer Society The American Cancer Society is the largest non-governmental source of cancer research funding in the United States and supports psychosocial and behavioral research. In FY 2001-2002, approximately 20 percent of the total research program was devoted to these areas (see Table 8-6). The Societyâs intramural research program includes a Behavioral Re- search Center, which is conducting two large population-based surveys of
210 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER TABLE 8-6 ACS Extramural and Intramural Funding in Selected Priority Areas:a FY 2001-2002 (in thousands) Area of Research $ Awarded Total 102,415 Prevention 13,648 Nutrition 4,013 Tobacco control 3,141 Other prevention 6,494 Detection 6,051 Treatment 22,849 Psychosocial and behavioral 20,471 Poor and underserved 10,780 Childhood cancer 4,257 Environmental carcinogenesis 909 Epidemiology 6,112 Cause/etiology 36,637 Major organ sites Breast 27,312 Leukemia 14,000 Colon/rectum 14,990 Lung 12,711 Lymphoma 5,534 Prostate 8,071 Ovary 5,108 Melanoma 4,679 Pancreas 7,845 Brain/nervous system 2,165 aNot mutually exclusive categories: e.g., a grant that is both prevention and detection is counted twice, as is a grant that studies both breast and prostate cancers. A grant emphasizing nutrition in breast and prostate cancer is counted in full in all three places. Dollar amounts are rounded off to the nearest $1,000. SOURCE: American Cancer Society, http://www.cancer.org/docroot/RES/content/ RES_7_3_Funding_By_Research_Area.asp, accessed May 1, 2003. cancer survivors. The first is the Study of Cancer SurvivorsâI (SCS-I), a longitudinal study of the needs and quality of life of adult cancer survivors. Participating survivors complete questionnaires at 1, 2, 5, and 10 years after diagnosis, allowing a comparison of changes over time and an assess- ment of the long-term impact of cancer on survivors. The participants in this study are selected with the cooperation of state cancer registries from the lists that they maintain of people diagnosed with cancer, thus allowing a more inclusive sample to be selected from this population than is usually employed in studies done by academic cancer centers. An additional strength
RESEARCH 211 of the research design of this study is its inclusion of more types of cancer than are usually included in a single study, thus allowing comparisons of the psychosocial effects of multiple cancer types. The studyâs sample in- cludes adults diagnosed with 1 of 10 common cancers (prostate, female breast, lung, colorectal, bladder, non-Hodgkinâs lymphoma, skin mela- noma, kidney, ovarian, and uterine). SCS-I also has the advantage of being designed to include a sufficient number of minority and younger survivors to allow assessments of the unique needs of these understudied groups. SCS-I also includes a family caregiver research component to explore the impact of the familyâs involvement in cancer care on the quality of life of the cancer survivor and the family caregiver. This research will identify the prevalence of the familyâs involvement in cancer care, identify unmet needs of caregivers at 2 and 5 years after diagnosis, and examine the impact of the caregiving on the quality of life and health behaviors of the caregiver. The second population-based survey of cancer survivors is the Study of Cancer Survivors âII (SCS-II), a national cross-sectional study of 2-, 5-, and 10-year cancer survivors that focuses on quality of life and psychosocial functioning. Over 30,000 survivors of breast, prostate, colorectal, urinary bladder, skin melanoma, and uterine cancer from across the nation are par- ticipating in this study. This study will evaluate the psychological needs, adjustment, and quality of life of cancer survivors and provide information now on longer-term cancer survivors. The results will provide a basis for advocacy and planning by the American Cancer Society as well as by other health organizations and agencies. Other research that the ACS Behavioral Research Center is conducting includes a study of the use of complementary therapies by breast and pros- tate cancer survivors, as well as a corresponding survey of physicians who treat cancer patients. The physiciansâ survey explores physician-patient com- munications about complementary therapies. The Behavioral Research Cen- ter has also conducted surveys of primary care providers to determine their knowledge, use, and evaluation of cancer screening guidelines. Avon Foundation Avon Products, Inc., a manufacturer of cosmetics, founded the Avon Breast Cancer Crusade in 1993 to support breast cancer research and to improve access to care, especially among medically underserved women. With $250 million raised since its inception, the program supports pro- grams for breast cancer in the United States and in 50 countries around the world. Originally designed to provide education, screening, and breast exam services to the underserved community, Avon expanded the crusade in 2000 by funding:
212 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER â¢ Community outreach and referral programs. â¢ Support services for breast cancer patients and survivors, including financial assistance for biopsies for uninsured women, counseling, trans- portation, and childcare â¢ Educational seminars that teach the âscienceâ of breast cancer and methods of effective advocacy. â¢ Medical research on breast cancer. Selected programs that support psychosocial care are shown in Table 8-7. Avon also collaborates with the National Cancer Institute âProgress for Patientsâ award program. The purpose of the program is to accelerate and expand translational research in breast cancer. Funding goes directly to United States scientists who compete for the awards. Avon Foundation dol- lars support direct costs of early phase breast cancer clinical trials and other studies in prevention, diagnosis, and treatment, including studies focusing on the needs of minority and other medically underserved patients. The NCI supports other costs of managing the program and the peer review process. The Susan G. Komen Breast Cancer Foundation The Susan G. Komen Breast Cancer Foundation is one of the nationâs largest private funders of breast cancer research, awarding more than 700 grants totaling $90 million since its inception in 1982. The Komen Foundationâs Research Program is funded by 25 percent of all funds raised by Komen Affiliates and Komen Race for the Cure events across the United States, as well as by certain private and corporate donations. In addition to research programs, Komen Affiliates throughout the United States fund community-based breast health education and breast cancer screening and treatment projects (STEP) for the medically under- served. In order to ensure that they are funding programs that address the specific unmet breast health needs of their communities, Komen Affiliates work with local medical experts and community leaders to conduct com- prehensive community needs assessments. These profiles are then used to establish local grant application and review processes. From 1998 to 2002 $97 million was awarded through the STEP program. Selected psychosocial programs supported through the program are shown in Table 8-8. A Population Specific Program of the Komen Foundation funds inno- vative projects studying the prevention and control of breast cancer within certain at risk populations (Table 8-9). The focus of the program is to sup- port research designed to assess and identify unique needs, trends, barriers and solutions to breast health care among populations such as African American, Asian American, Native Hawaiian and Pacific Islanders, Hispanic/
RESEARCH 213 TABLE 8-7 Selected Programs Supported by the Avon Breast Cancer Crusade Amount Awarded Through October 2002 Program (in millions) Avon Foundation Comprehensive Breast Evaluation Center, $12.2 Massachusetts General Hospital â¢ Funding brings the hospitalâs leading edge breast cancer screening, diagnostic, and research capabilities to one location; it also supports a high risk breast evaluation center, new research projects in breast cancer genetics and biology, expands ongoing research and enhances access to clinical care and breast cancer treatment for women in community- based health care centers. Cancer Care, Inc. (NY) $11.2 â¢ New York City-based Cancer Care has established the national "AVONCares" Program for Medically Underserved Women, which provides financial assistance for breast cancer clinical diagnostic services; transportation and an escort to and from treatment and diagnostic workups; and elder- or childcare while undergoing breast cancer treatment or diagnostics. Women assisted by the "AVONCares" program are able to receive Cancer Care's other services, including professional counseling, education and information, breast prostheses and wigs. National Breast Cancer Coalition 4.0 â¢ Support to develop leadership skills among cancer advocates and to develop A Guidebook to Quality Breast Cancer Care: a consumer guide that helps women define quality breast care and secure access to evidence-based and patient-centered treatment and care. Y-Me National Breast Cancer Organization (US) 2.5 â¢ Funds support expansion of the Y-Me support of Latino, Chinese and Vietnamese women. The programs educate these underserved women and link them directly to screening; assist women who have abnormal screening results in obtaining proper follow-up care; provide translation services; expand the Y-Me husband/partner hotline; and expand the Y-Me teen program, which trains high school seniors in early detection and encourages them to educate their families and neighbors. The Cleveland Clinic (OH) 2.1 â¢ Funds support community outreach and care for the underserved and improved clinical facilities in the Women's Health Pavilion. (continued)
214 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER TABLE 8-7 (Continued) Amount Awarded Through October 2002 Program (in millions) Food & Friends (DC) 1.0 â¢ Organization runs a delivery service of meals and groceries to women with breast cancer to ensure that women suffering from breast cancer, along with their families, have access to better nutrition, reduced stress and improved outlook. The program also provides nutritional education and counseling. The Avon funding will cover delivery of more than 1,500 meals a week to women referred by numerous community partners and construction of the Avon Foundation Kitchen at the organizations' new facility opening October 2003. âRise Sister Riseââ of Breast Cancer Resource Committee (DC) .7 â¢ National implementation of a model support group program for African-American women recovering from breast cancer. Inova Health System Foundation/Fairfax Hospital (VA) .6 â¢ Funds support maximizing relationship between the Women's Center and Fairfax Hospital Cancer Center, focusing on Asian and Hispanic women who are medically underserved. Women are taught to understand early detec- tion, risk reduction, how to obtain access to clinical screen- ing, diagnostic and treatment services, including clinical trials. Boston Medical Center (MA) .5 â¢ Funds support a comprehensive breast cancer screening and diagnostic program targeted to women challenged by language, cultural and economic barriers. The Women's Health Group at BMC launched the Avon Foundation Breast Health Initiative linking clinicians, outreach/inreach workers, advocates, and researchers in order to better serve women in poor, urban communities, thereby improving the rate of undetected breast cancer and overall health outcomes. Stroger Hospital of Cook County/Hektoen Institute for Medical .5 Research (IL) â¢ Funds bring state-of-the-art quality breast oncology care to minority-underserved populations in their own communities through participation in NCI-approved clinical trials that specifically recruit for minority participation; extend and promote these research opportunities with emphasis on the particular needs of the community served, promoting outreach and education; focus on prevention and control as methods for reducing breast cancer incidence, morbidity and mortality, with special emphasis on involvement and educa- tion of patient advocacy groups, women's support groups, and primary care physicians.
RESEARCH 215 TABLE 8-7 (Continued) Amount Awarded Through October 2002 Program (in millions) Karmanos Cancer Institute (MI) .5 â¢ Funds support three related projects: the Community Re- source Liaison Project, designed to make clinical trials more readily available to underserved women; the Mobile Detec- tion Center, which will travel around Michigan throughout the year, increasing access for mammography screening; and the Image Checker, which converts film screen to digital images and identifies areas of suspicion. Univ. of Miami/Sylvester Cancer Center (FL) .5 â¢ Funds are enhancing the infrastructure of the breast clinic at Jackson Memorial Hospital, a public hospital that serves the poor in Miami, in particular, women born in Latin America and the Caribbean and African Americans. Moores Univ. of Calif. At San Diego Cancer Center (CA) .5 â¢ Funds enable the Cancer Center to expand its efforts to build on existing programs in community outreach, clinical cancer genetics, diet intervention and state of the art breast care with underserved populations. Univ. of Texas Southwestern Medical Center/Parkland .5 Hospital (TX) â¢ Funding supports the Avon Foundation Breast Cancer Program, focusing on facilitating easier access to care and clinical trials for the medically underserved, and identifying and monitoring women in populations at greater risk for breast cancer. SOURCE: Accessed from Avon website at www.avoncompany.com/women/avoncrusade/ services/beneficiaries_factsheet.shtml), accessed Feruary 20, 2003. Latina, Native American, Lesbian, Low Literacy, Breast Cancer Survivors, Women with Disabilities, and other defined communities. Areas of interest include cancer prevention and control, behavioral science research, epide- miology, and health service delivery programs. Komen gives preference to applicants who demonstrate collaboration with a community-based organi- zation. This program offers funding of up to $250,000 (combined direct and indirect costs) over a 2- or 3-year period. Bristol Meyers Squibb Foundation The Bristol Meyers Squibb Foundation has sponsored a demonstration project (currently in its second phase) to bring more psychosocial services
216 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER TABLE 8-8 Selected Programs Supported Through the Susan G. Komen Breast Cancer Foundation, 2000-2002 Psychosocial STEP Grants and Funding Grant Program Institution Komen Affiliate Educational Support Program for The Wellness Community South Florida Women with Breast Cancer Outreach Services for Women with Center for Hope, Inc. Greater New York City Breast Cancer Cancer Patient Matching and Cancer Hope Network North New Jersey Support Psychosocial Support for Latino The Wellness Community Los Angeles County Women with Breast Cancer Art and Educational Therapy Pilot Presbyterian Healthcare Central New Mexico Program Services Complementary Alternative Charlotte Maxwell San Francisco Bay Area Medicine, Education & Advocacy Complementary Clinic for Breast Cancer LatinaSHARE: Medical/Community SHARE: Self-Help for Greater New YorkâCity Outreach and Mentoring Project Women with Breast or Ovarian Cancer, Inc. Psychosocial Support Services for The Wellness Community San Diego Breast Cancer Patients Counseling for Breast Cancer UNC Lineberger NC Research Triangle Patients Comprehensive Cancer Area Center Breast Cancer Education and Cancer Care, Inc. New Jersey Race for the Support Project CureÂ® Year 2001 Casting for Recovery Casting for Recovery Vermont Retreats A Healing Journey St. Maryâs Foundation Greater Evansville, IL Pre-Operative Robert Wood Johnson New Jersey Race for the Education/Complementary Therapy University Hospital CureÂ® Consultation Foundation Outreach to the Underserved Gildaâs Club Nashville Greater Nashville Check It Out St. Louis Chapter of St. Louis Hadassah Breast Cancer in Young Women: Washington University St. Louis Establishing an Outreach and School of Medicine Mentoring Program
RESEARCH 217 TABLE 8-8 (Continued) Grant Program Institution Komen Affiliate Group Therapy for Newly Wake Forest University North Carolina Triad Diagnosed African American Breast Baptist Medical Center Cancer Patients Psychosocial Support for Latino The Wellness Community Los Angeles County Women with Breast Cancer Support Services for Breast Cancer The Wellness Community San Diego Patients with a Focus on Underserved Populations Casting for Recovery 2002 Casting for Recovery Vermont Cancer Patient Matching and Cancer Hope Network North New Jersey Support LatinaSHARE: Medical and SHARE: Self-Help for Greater New York City Community Outreach and Women with Breast or Mentoring Project Ovarian Cancer, Inc. WomensCare Center Breast Health St. Rose Dominican Las Vegas Program Hospital and St. Rose Dominican Health Breast Health Resource Guide Orange County Breast Orange County Cancer Coalition Counseling for Breast Cancer UNC Lineberger NC Triangle Area Patients Comprehensive Cancer Center Support for Life: Women Focused The Wellness Community Phoenix on Recovery Complementary Alternative The Charlotte Maxwell San Francisco Bay Area Medicine, Psychosocial Support, Complementary Clinic Advocacy, and Education for Low Income Women with Breast Cancer WINGS WINGS San Antonio Breast Cancer Registry, Barbara Ann Karmanos Detroit Race for the Psychosocial Screening, and Cancer Institute CureÂ® Improvement of Compliance and Reduction of Distress Breast Health Education for Nurses Intermountain Health Care Salt Lake City Breast Cancer Support and Education Cancer Care Connecticut Project for Underserved Women Education and Psychosocial Support Cancer Wellness Chicago for Women with Breast Cancer Organizations of Metropolitan Chicago Area SOURCE: http://www.komen.org/grants/step/stepresults.asp, accessed February 20, 2003.
218 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER TABLE 8-9 The Susan G. Komen Breast Cancer Foundation 2001 Population Specific Grants Amount (in Grant Institution US$) Health Care Experiences of Boston University $120,638 Lesbians with Breast Cancer Variation in Stage at Public Health Institute $128,867 Diagnosis in Breast Cancer Across California: Effects of Race/Ethnicity and Rural/Urban Residence Influence of Behavioral Howard University $215,168 Factors on Breast Cancer Risk and Survival African American Lesbian Mautner Project for Lesbians $237,847 Breast Cancer Screening with Cancer Study Korean American Breast The Johns Hopkins University $249,442 Health Project in Maryland Breast Cancer Control: Needs University of Southern $248,483 and Practices of African Mississippi American Women and Their Providers Genetic Epidemiology of Wayne State University $249,493 Breast Cancer in African Americans Impact of Culture on Breast Georgetown University $249,998 Cancer Screening in Chinese American Women Project Hoffnung: Delivering University of Utah College of $249,969 Hope with Culturally Nursing Appropriate Breast Health to Amish and Mennonite Communities âComadre A Comadreâ A University of New Mexico $250,000 One-on-One Peer Support Project for Hispanic Women with Breast Cancer Not Yet Well: the Self University of California, Los $248,183 Management of Post-Treatment Angeles Symptoms by Breast Cancer Survivors
RESEARCH 219 TABLE 8-9 (Continued) Amount (in Grant Institution US$) The Helping Path, Four University of California, Los $247,065 Directions: A California Angeles Indian Breast Cancer Education Lay Health Advisors to University of Michigan $250,000 Promote Breast Cancer Screening Among Asian Americans Total $2,945,153 SOURCE: Accessed from website: http:Hwww.komen.org/grants/awards/O I awards. asp?id=1, accessed February 20, 2003. to patients and their families at a local level. A second goal is to test the feasibility of training masterâs level counseling psychologists in psychoso- cial oncology in order to increase the cadres of professionals available to patients in smaller communities. To date, 150 psychologists in Florida have been given face to face and online training in psychosocial counseling in oncology. A current plan is to explore the development of this group further in an effort between the Ameri- can Psychosocial Oncology Society (APOS) and the Bristol Meyers Squibb Foundation in which APOS will provide a core online curriculum and an examination to those who wish to add qualifications in psychosocial oncol- ogy. Counselors in Employment Assistance Programs and family service or- ganizations, already trained in counseling should be rather easily trained in psychosocial issues in oncology. If so, the demonstration will have been able to increase the number of psychosocial oncology counselors with a wider geographic distribution who can be reached through the APOS Referral Di- rectory and toll-free number, along with the traditional psychosocial oncol- ogy professionals (www.apos-society.org; 1-866-APOS-4-HELP). SUGGESTIONS FOR FUTURE RESEARCH PRIORITIES Relative to other areas of research in breast cancer, psycho-oncology is still in its infancy. Just over 20 years have elapsed since the first randomized psycho-oncology trial in breast cancer was reported by Maguire in 1980 (Maguire et al., 1983), and for this report Goodwin was able to find and review a total of 31 randomized trials in women with breast cancer in the literature (see Chapter 5). These trials cover a broad spectrum of interven-
220 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER tions (relaxation/hypnosis with or without imagery, group interventions involving structured or unstructured groups, supportiveâexpressive therapy, cognitiveâbehavioral therapy, mindâbodyâspirit interventions, psycho-edu- cational interventions and/or peer discussion, as well as individual interven- tions involving telephone counseling, specialized nursing interventions, cog- nitiveâbehavioral therapy and problem-solving skills training). The reported trials have enrolled from 24 to 312 women, and the interventions evaluated have ranged from 75 minutes to lifelong. Some general conclusions can be drawn regarding the effectiveness of these psychosocial interventions in breast cancer. For example, there is fairly consistent evidence that relax- ation/hypnosis/imagery interventions are beneficial in a variety of acute care settings, particularly in the short-term. Furthermore, there is growing evi- dence of the efficacy of a variety of group and individual interventions, using different strategies for different periods of time at different points along the breast cancer trajectory. Despite this, many unresolved questions remain which should be the focus of future research activities. Based on discussions at its workshop, the analysis of Goodwin in her commissioned paper, and its own deliberations reviewing the trials presented and analyzed in Chapter 5, the Board was able to formulate some suggestions for areas of needed research and priori- ties. Along with some brief comments on the relevance of psychosocial re- search in other than breast cancer and on indexing, coordination, and col- laboration issues, these suggestions are discussed below. The Board believes that much of value can be learned building on the base of the existing trials. Determining Relative Benefits of Different Interventions Most of the reported randomized trials have compared an active inter- vention to a no-treatment control group, an attention control group, or a control group that passively received educational materials. Few have com- pared different active interventions. As a result, there is little information available regarding whether one intervention is better than others and, if so, whether such interventions are more effective in all settings, and with all types of patients, or whether specific interventions are more effective with specific groups of patients. With some types of interventions, such as relax- ation/imagery, the approach to the intervention does not appear to be as important as the fact that the intervention was delivered. In other types of interventions, for example, individual interventions, the specific approach appears to be critical in determining benefits of the intervention. Further- more, although there is early evidence that group interventions (of a variety of types) are beneficial in both early stage and advanced breast cancer, it is unclear whether one type of group intervention is better than others, what the optimal duration of such intervention should be, whether the type or
RESEARCH 221 duration of the intervention should be tailored to individual patient charac- teristics or phase of illness, and, if that is the case, what those characteristics are. Existing research suggests that the psychological profile of the patient may be one such characteristic (Goodwin et al., 2001; Hosaka et al., 2001b, 2000a, 2000b, 2000c). Additional research to directly compare different interventions that have been shown to be effective in breast cancer (e.g., expressiveâsupportive group therapy versus cognitiveâbehavioral group therapy) is important in order to determine the relative effectiveness of these interventions overall and in subgroups of interest (e.g., distressed versus non-distressed). Ideally, this research should be conducted in early stage and advanced breast cancer separately as it is possible that effects may differ. Similarly, group interven- tions should be compared to individual interventions and efforts made to identify the benefits of different components of the more complex interven- tions (e.g., the contribution of relaxation and imagery to a cognitiveâbehav- ioral intervention). In this comparative research, outcome measures should be selected that target attributes likely to be influenced by the intervention (e.g., psychological statusâmood, traumatic stress symptoms, copingâas well as overall quality of life, patient satisfaction, and cost-effectiveness). Given the current evidence of a variety of benefits of psychosocial interven- tions in breast cancer, the use of no-treatment control arms may become increasing difficult for ethical reasons; this will enhance the likelihood of comparative research in future. Determining Optimal Timing and Duration of Psychosocial Interventions In general, randomized trials of relaxation/hypnosis have tended to in- volve short interventions (one session to 6 months), whereas interventions in early stage breast cancer have been somewhat longer (4 weeks to 3 or 4 months), and interventions in women with metastases have been the longest (6 months to the end of life). However, none of the randomized trials to date has evaluated the effect of duration of the intervention on the magnitude and persistence of psychosocial benefits or on cost-effectiveness. Randomized tri- als to evaluate the optimal duration of intervention will be important, and these trials should be conducted separately in early stage and late stage breast cancer, as it appears likely the optimal duration of the intervention differs according to the disease stage. Within each phase of illness, research is also needed to identify the optimal timing of psychosocial interventions. Identifying Patient Characteristics Associated with Intervention Benefits A number of the published trials have suggested that psychological ben- efits vary according to patient characteristics. For example, Goodwin et al.
222 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER found that psychological benefits of supportiveâexpressive therapy in meta- static breast cancer were limited to women who were distressed at the time the intervention began (Goodwin et al., 2001). Similar differential effects in subgroups of women have been reported by others, although there is little evidence that predictors of benefit are consistent across studies (Hosaka et al., 2000c, 2001a, 2001b, 2000b). Many of the predictors will likely be psychosocial in nature (e.g., presence of acute distress, underlying psycho- social illness or adjustment disorder, personality traits, social and family support). However, some may involve demographic characteristics (e.g., age, social status) or medical factors. For example, relaxation/imagery has been shown to be effective in early-stage breast cancer, but the single trial in women with metastases yielded no benefit (Arathuzik, 1994). Although these results should not be interpreted as proof of benefit only in early disease, they point to the need for more formal evaluation in the metastatic setting. Because it is possible that some women may benefit more from certain interventions and, indeed, that certain interventions may benefit certain types of women to a greater extent than others, research is desirable to further examine the patient characteristics that are predictive of greatest benefit of psychosocial interventions in breast cancer. Some of this research might involve re-analysis of existing trials, but it is likely that new trials will also be necessary. One of the goals of this research should be to determine whether some women do not require psychosocial intervention, in the same way that some women do not require adjuvant chemotherapy. Understanding the Role of Nursing Interventions A considerable number of randomized trials, predominantly in early stage breast cancer, have evaluated nursing interventions. There is some evidence of benefit for these nursing interventions. However, these studies all evaluated different interventions, some used small sample sizes, and some of the studies had significant methodologic limitations. Because nurses are so intimately involved in the care of breast cancer patients, better under- standing is needed of the precise benefits of specialized nursing interven- tions on the psychosocial status of women with breast cancer and how these interventions are best integrated into a more comprehensive psycho- social intervention program. Evaluating Peer Support/Peer Discussion Groups Peer support groups have gained widespread acceptance among women with breast cancer. However, there is little clear evidence of benefit, and the single randomized trial that evaluated facilitated peer discussion failed to identify any psychological benefits (Helgeson et al., 2000, 1999). Although
RESEARCH 223 many testimonials exist as to the benefits of individual peer support (Cella and Yellen, 1993), formal evaluation of the benefit of this support is lack- ing. Given the nature and widespread availability of peer support, the use of randomized designs may be challenging; however, evaluation using the strongest methodology possible is needed. Evaluating Novel Interventions There is growing interest among breast cancer patients and their families in the potential benefits of non-traditional, complementary and alternative medicine approaches to psychosocial support. These approaches include Internet chat groups and peer support groups, as well as a variety of non- traditional therapies, many of which focus on helping patients distract them- selves from their breast cancer experience or turn their focus to other areas of their lives. Such interventions include yoga, reflexology, reiki, tâai chi, music therapy, and art therapy. Because these interventions are of great interest to patients, and because they are often pursued by patients with little evidence of benefit apart from anecdotal testimonials, formal evalua- tion of their benefit in the setting of randomized trials would be useful. Such trials could include wait list control groups if resistance to randomiza- tion is encountered. The importance of research in this area is highlighted by the observations of Targ and Levine that a complex mindâbodyâspirit group intervention was at least equivalent to a standard psychoeducational support group intervention and that it led to enhanced satisfaction, fewer dropouts, and greater spiritual integration. Addressing the Needs of Breast Cancer Survivors Only one randomized trial of a purely psychosocial intervention was conducted in breast cancer survivors, and it did not address the psychoso- cial needs of breast cancer survivors (Fogarty et al., 1999). Instead, it used them as a convenience sample to evaluate the benefits of an enhanced com- passion videotape. Research into survivorship issues is just beginning, but it is an important area involving millions of people. This research should be facilitated, and, as problems are identified, targeted interventions should be developed and tested to address the unique needs of this large population. Addressing Family Issues Only a small number of the randomized trials reported to date have involved partners or family members of breast cancer patients. Yet it is widely recognized that these individuals are often greatly affected by the illness of the breast cancer patient and that they may suffer significant emo-
224 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER tional distress that may continue long after the breast cancer patient dies. The Board believes that research should be pursued to identify the psycho- social needs of this population and to develop interventions to ameliorate their psychological distress. Addressing Cultural/Minority Issues None of the randomized trials in the United States addressed cultural and/or minority issues. Although there is some evidence from some coun- tries outside of the United States that psychosocial interventions may have similar effects in different cultures, the influence of cultural and/or minority background requires further investigation (Fukui et al., 2000; Hosaka et al., 2000a, 2000b, 2000c, 2001a, 2001b). Specifically, descriptive research should be carried out to examine the unique needs of different cultures and/ or minority groups, followed by development of interventions that target these unique needs. Developing Appropriate Measures of Psychosocial Outcomes Many of the randomized trials reported to date have used a fairly con- sistent group of well studied psychosocial questionnaires, including the Pro- file of Mood States, the Impact of Events Scale, the Beck Depression Inven- tory, and the State Trait Anxiety Index. However, many others have used novel instruments, some of which are not well validated or are not well known. Furthermore, the standard psychosocial measurement instruments do not address all of the outcomes that are of interest in psychosocial inter- vention trials in breast cancer. A critical review is needed to identify do- mains and attributes that are not well addressed by well characterized ques- tionnaires commonly used in breast cancer psychosocial intervention studies (e.g., cognitive functioning), to identify instruments used in other settings that measure those attributes, and to identify areas where there should be development of new instruments. The importance of different psychosocial outcomes should be prioritized (to the extent possible), and the magnitude of psychosocial benefit that is clinically important should be explored. This research might involve a consensus conference to identify a small number of clearly defined outcomes that could be used across a broad spectrum of trials so that the results of trials are more readily compared, followed by targeted research studies. Translation of Research Findings to Community Practice There is considerable evidence of efficacy of some types of psychosocial interventions in breast cancer; however, the extent to which these interven-
RESEARCH 225 tions are used in clinical practice is unclear. Therefore, the current use of psychosocial interventions in breast cancer in academic and private medical practice should be evaluated. This evaluation should address access to, and utilization of, relaxation/hypnosis, peer support, and novel forms of sup- port discussed above as well as more traditional group and individual inter- ventions. An assessment of barriers to more widespread use of psychosocial interventions in breast cancer may be useful. Such barriers include (but are not limited to) cost, patient acceptability, physician acceptability, availabil- ity and preferences of psychosocial practitioners, logistical barriers to deliv- ery, and knowledge of (or belief in) the effectiveness of psychosocial inter- ventions. Evaluations are needed of psychosocial interventions implemented in âreal worldâ settings, in which cost and integration into breast care in various community settings are assessed (Redman et al., 2003). Applicability of Findings from Other Research to Women with Breast Cancer In addition to the psychosocial research conducted in breast cancer patients reviewed here, there is also a large body of literature describing psychosocial research in other cancer types and in patients with other seri- ous illnesses. The extent to which the results of this research in other set- tings are generalizable to women with breast cancer is not clear. A critical review of the published literature in other illnesses, focusing predominantly on other cancers, could provide evidence of generalizability, or lack of generalizability, of psychosocial research findings in these other settings to breast cancer. Tracking Results of Psycho-Oncology Studies Indexing of psycho-oncology studies is inconsistent and may be delayed depending on the journal used. Because these trials may be published in journals related to different disciplines, they are often difficult to find, even in exhaustive literature searches. Encouragement of a more standardized and timely approach to indexing would be helpful. A prospective registry of psychosocial intervention trials would facilitate tracking of ongoing studies and assist in planning of new intervention trials. FINDINGS AND RECOMMENDATIONS These research priorities will be addressed most effectively if the psycho- oncology research community works together to build on the strengths of previous research and to ensure that future research provides clinically meaningful information. Unless there is a compelling reason to study en-
226 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER tirely new intervention approaches, the comparative research outlined above should compare two or more therapies that have previously been shown to be effective; the most effective therapy can then be used in subsequent com- parative work. Similarly, if one or more patient characteristics are identi- fied as being predictive of benefit in one intervention study, future studies should examine those characteristics (as well as others if desired) in an attempt to replicate the earlier finding and contribute to a body of knowl- edge regarding predictors of benefit. This approach may be facilitated by more widespread conduct of multicenter trials of psychosocial interven- tions, a move away from many of the single-center studies that have been reported to date. In order to facilitate this broader type of research, it may be necessary to establish psychosocial intervention research networks, simi- lar to those that exist for evaluation of other breast cancer treatments (che- motherapy, radiation, surgery). These collaborative networks might be âfree standing,â but the benefits of integrating these networks into already estab- lished clinical trials groups should also be explored. To continue progress in the research base that is necessary for sound development of interventions to address psychosocial, psychiatric, and qual- ity of life issues in breast cancer, the Board recommends: 1. Research sponsors (e.g., NCI, ACS) and professional organizations (e.g., American Society of Clinical Oncology, American College of Sur- geons, American Association of Colleges of Nursing, American Psychoso- cial Oncology Society, American Society of Social Work, American Soci- ety for Therapeutic Radiology and Oncology, Oncology Nursing Society) need to support efforts in collaboration with advocacy groups (e.g., Na- tional Breast Cancer Coalition; National Alliance of Breast Cancer Orga- nizations) to enhance practice environments to promote coordinated, com- prehensive, and compassionate care. Rigorous evaluations are needed of the cost and effectiveness of delivery models that show promise in improv- ing access to psychosocial support services. These might include: â¢ Collaborative practices in which a psychologist or other mental health provider forms a partnership with an office-based oncology provider to make psychosocial services available within the oncology practice; â¢ Comprehensive breast cancer centers that generally integrate sup- portive care into a âone-stop-shoppingâ model of clinical practice; â¢ Breast cancer nurse managers who provide case management, educa- tion, and supportive care within oncology practices; â¢ Novel models of psychosocial services, such as ICAN project, in phase 2 demonstration, which utilizes masterâs level counselors who receive a core curriculum in psychosocial oncology;
RESEARCH 227 â¢ Demonstration projects to test the effectiveness of clinical practice guidelines on the management of psychosocial distress in improving psy- chosocial outcomes; â¢ Development of measures of quality of cancer care that pertain to supportive care (including psychosocial services). Measures might include provider assessment of psychosocial concerns, the provision of information regarding community supportive care resources, and satisfaction with care. In general, investigators working in this field should recognize that studies in the past would in many cases have been stronger if they had been on other than selected patients mostly in tertiary settings, or had not been unblinded, with small sample size, of insufficient power, of short duration, and the like. Future study designs should try to minimize such weaknesses. 2. Research sponsors (e.g., NCI, ACS) should continue to support ba- sic and applied psycho-oncology research. This might include: â¢ Further development of simple, rapid screening tools for identifying the patient with distress in outpatient offices and training of primary oncol- ogy teams in diagnosis of distress that exceeds the âexpectedâ and when referral to supportive services should be made; â¢ Studies that assess the relative effectiveness of various psychosocial interventions, using population-based patient samples of adequate size, the timing and duration of interventions, and innovative and inexpensive modes of administration (e.g., Internet-based approaches); â¢ A consensus conference to develop a battery of standard instruments for outcome measures to permit comparison of data from studies carried out by different research groups; â¢ Organization of a psychosocial clinical trials group in which a net- work of researchers could address key questions in multicenter studies that would allow access to large, population-based samples; â¢ Clinical trials of psychosocial interventions that are conducted within routine breast cancer care in which cost and quality of life are outcome measures; â¢ A registry of ongoing psychosocial research/trials to assist research- ers in identifying and tracking new areas of study. 3. The NCI should support a special study to ascertain the use of, and unmet need for, cancer-related supportive care services (including psycho- social services) in the United States. The results of such a study could pro- vide benchmarks against which care can be measured and performance monitored. Such a study would document existing disparities in service use by age, race/ethnicity, geography, and insurance coverage.
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