The National Cancer Policy Board, in an effort to understand how resources for research are applied to questions regarding psychosocial 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 psychosocial subjects as components within the field of breast cancer research, and a sense of the emphasis on different concerns and services within psychosocial 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

Privately Sponsored Research

Although these organizations are not the only sponsors of breast cancer-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 Board’s identification of priority areas for research and recommendations to increase research opportunities.

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 dictionary of medical subject headings called MESH terms).

The volume of breast cancer-related psychology research articles appears 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 psychological research.

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:

• Listings of research projects provided by some organizations (e.g., National Cancer Institute);

• The federal listing of research projects (CRISP);

• Review of agency web sites (e.g., Department of Defense); and

FIGURE 8-1 PubMed citations for breast cancer psychological research, 1990–2000. Citations were identified in the National Library of Medicines’s PubMed database using the MESH term “breast neoplasms,” and the MESH subheading “psychology.” Only articles published in English are counted.

• 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 nation’s 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.

The main locus of cancer-related psychosocial research support within the Department of Health and Human Services (DHHS) is the National Cancer Institute (NCI). Table 8-1 describes the NCI’s 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-

FIGURE 8-2 PubMed citations for psychology related breast cancer research as a percentage of all breast cancer-related research, 1990–2000. 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 “breast neoplasms.” Only articles published in English are counted.

vorship research has been designated by NCI as an “Extraordinary Opportunity for Investment.” 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).

NCI’s 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 providers, 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.

Psychosocial research is also supported through the NCI’s Office of Behavioral Research (BRP). Research supported in this office ranges from basic behavioral research to research on the development, testing and dis-

semination of disease prevention and health promotion interventions in areas 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):

• Applied Cancer Screening Research. Facilitates and supports effectiveness 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.

• Basic Biobehavioral Research. To serve as a national model for promoting, sponsoring, and supporting basic biobehavioral research and training.

• Health Communication and Informatics Research. To advance communication and information science across the cancer continuum—prevention, detection, treatment, control, survivorship, and end of life. Communication and information science systematically examines the fundamental processes and effects of human and mediated communication.

• Health Promotion Research. Coordinates research on non-tobacco behavioral prevention of cancer in the areas of diet, physical activity, energy balance, virus exposure, and sun exposure.

• Tobacco Control Research. To reduce cancer incidence and mortality 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.

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 Service’s first-class stamp (Public Law 105-41, Stamp Out Breast Cancer Act [H.R. 1585]). The CDMRP strives to identify gaps in funding and provide award opportunities that will enhance program research objectives without duplicating existing funding opportunities.

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 “visionary research.” Within the BCRP, psychosocial research awards fall within the category of “Biobehavioral Sciences.” A total of 35 of the 105 biobehavioral awards of the BCRP pertain to psychosocial issues (Table 8-5).

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.

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 Society’s intramural research program includes a Behavioral Research Center, which is conducting two large population-based surveys of

cancer survivors. The first is the Study of Cancer Survivors–I (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 assessment 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

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 study’s sample includes adults diagnosed with 1 of 10 common cancers (prostate, female breast, lung, colorectal, bladder, non-Hodgkin’s lymphoma, skin melanoma, 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 family’s 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 family’s 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 –II (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 participating 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 prostate cancer survivors, as well as a corresponding survey of physicians who treat cancer patients. The physicians’ survey explores physician-patient communications about complementary therapies. The Behavioral Research Center has also conducted surveys of primary care providers to determine their knowledge, use, and evaluation of cancer screening guidelines.

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 programs 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:

• Community outreach and referral programs.

• Support services for breast cancer patients and survivors, including financial assistance for biopsies for uninsured women, counseling, transportation, and childcare

• Educational seminars that teach the “science” of breast cancer and methods of effective advocacy.

• 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 “Progress for Patients” 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 dollars 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 is one of the nation’s largest private funders of breast cancer research, awarding more than 700 grants totaling $90 million since its inception in 1982. The Komen Foundation’s 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 underserved. 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 comprehensive 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 innovative projects studying the prevention and control of breast cancer within certain at risk populations (Table 8-9). The focus of the program is to support 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/

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, epidemiology, and health service delivery programs. Komen gives preference to applicants who demonstrate collaboration with a community-based organization. This program offers funding of up to $250,000 (combined direct and indirect costs) over a 2- or 3-year period.

The Bristol Meyers Squibb Foundation has sponsored a demonstration project (currently in its second phase) to bring more psychosocial services

to patients and their families at a local level. A second goal is to test the feasibility of training master’s level counseling psychologists in psychosocial 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 American 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 oncology. Counselors in Employment Assistance Programs and family service organizations, 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 Directory and toll-free number, along with the traditional psychosocial oncology professionals (www.apos-society.org; 1-866-APOS-4-HELP).

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-

tions (relaxation/hypnosis with or without imagery, group interventions involving structured or unstructured groups, supportive–expressive therapy, cognitive–behavioral therapy, mind–body–spirit interventions, psycho-educational interventions and/or peer discussion, as well as individual interventions involving telephone counseling, specialized nursing interventions, cognitive–behavioral 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 relaxation/hypnosis/imagery interventions are beneficial in a variety of acute care settings, particularly in the short-term. Furthermore, there is growing evidence 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 priorities. Along with some brief comments on the relevance of psychosocial research in other than breast cancer and on indexing, coordination, and collaboration issues, these suggestions are discussed below. The Board believes that much of value can be learned building on the base of the existing trials.

Most of the reported randomized trials have compared an active intervention to a no-treatment control group, an attention control group, or a control group that passively received educational materials. Few have compared 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 relaxation/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. Furthermore, 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

duration of the intervention should be tailored to individual patient characteristics 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., expressive–supportive group therapy versus cognitive–behavioral 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 interventions should be compared to individual interventions and efforts made to identify the benefits of different components of the more complex interventions (e.g., the contribution of relaxation and imagery to a cognitive–behavioral intervention). In this comparative research, outcome measures should be selected that target attributes likely to be influenced by the intervention (e.g., psychological status—mood, traumatic stress symptoms, coping—as well as overall quality of life, patient satisfaction, and cost-effectiveness). Given the current evidence of a variety of benefits of psychosocial interventions 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.

In general, randomized trials of relaxation/hypnosis have tended to involve 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 trials 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.

A number of the published trials have suggested that psychological benefits vary according to patient characteristics. For example, Goodwin et al.

found that psychological benefits of supportive–expressive therapy in metastatic 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 psychosocial 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.

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 understanding is needed of the precise benefits of specialized nursing interventions on the psychosocial status of women with breast cancer and how these interventions are best integrated into a more comprehensive psychosocial intervention program.

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

many testimonials exist as to the benefits of individual peer support (Cella and Yellen, 1993), formal evaluation of the benefit of this support is lacking. 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.

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 themselves from their breast cancer experience or turn their focus to other areas of their lives. Such interventions include yoga, reflexology, reiki, t’ai 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 evaluation of their benefit in the setting of randomized trials would be useful. Such trials could include wait list control groups if resistance to randomization is encountered. The importance of research in this area is highlighted by the observations of Targ and Levine that a complex mind–body–spirit 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.

Only one randomized trial of a purely psychosocial intervention was conducted in breast cancer survivors, and it did not address the psychosocial needs of breast cancer survivors (Fogarty et al., 1999). Instead, it used them as a convenience sample to evaluate the benefits of an enhanced compassion 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.

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-

tional distress that may continue long after the breast cancer patient dies. The Board believes that research should be pursued to identify the psychosocial needs of this population and to develop interventions to ameliorate their psychological distress.

None of the randomized trials in the United States addressed cultural and/or minority issues. Although there is some evidence from some countries 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.

Many of the randomized trials reported to date have used a fairly consistent group of well studied psychosocial questionnaires, including the Profile of Mood States, the Impact of Events Scale, the Beck Depression Inventory, 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 intervention trials in breast cancer. A critical review is needed to identify domains and attributes that are not well addressed by well characterized questionnaires 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.

There is considerable evidence of efficacy of some types of psychosocial interventions in breast cancer; however, the extent to which these interven-

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 support discussed above as well as more traditional group and individual interventions. 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, availability and preferences of psychosocial practitioners, logistical barriers to delivery, and knowledge of (or belief in) the effectiveness of psychosocial interventions. Evaluations are needed of psychosocial interventions implemented in “real world” settings, in which cost and integration into breast care in various community settings are assessed (Redman et al., 2003).

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 serious illnesses. The extent to which the results of this research in other settings 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.

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.

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-

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 comparative work. Similarly, if one or more patient characteristics are identified 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 knowledge regarding predictors of benefit. This approach may be facilitated by more widespread conduct of multicenter trials of psychosocial interventions, 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, similar to those that exist for evaluation of other breast cancer treatments (chemotherapy, radiation, surgery). These collaborative networks might be “free standing,” but the benefits of integrating these networks into already established 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 quality 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 Surgeons, American Association of Colleges of Nursing, American Psychosocial Oncology Society, American Society of Social Work, American Society for Therapeutic Radiology and Oncology, Oncology Nursing Society) need to support efforts in collaboration with advocacy groups (e.g., National Breast Cancer Coalition; National Alliance of Breast Cancer Organizations) to enhance practice environments to promote coordinated, comprehensive, and compassionate care. Rigorous evaluations are needed of the cost and effectiveness of delivery models that show promise in improving access to psychosocial support services. These might include:

• 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;

• Comprehensive breast cancer centers that generally integrate supportive care into a “one-stop-shopping” model of clinical practice;

• Breast cancer nurse managers who provide case management, education, and supportive care within oncology practices;

• Novel models of psychosocial services, such as ICAN project, in phase 2 demonstration, which utilizes master’s level counselors who receive a core curriculum in psychosocial oncology;

• Demonstration projects to test the effectiveness of clinical practice guidelines on the management of psychosocial distress in improving psychosocial outcomes;

• 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 basic and applied psycho-oncology research. This might include:

• Further development of simple, rapid screening tools for identifying the patient with distress in outpatient offices and training of primary oncology teams in diagnosis of distress that exceeds the “expected” and when referral to supportive services should be made;

• 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);

• 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;

• Organization of a psychosocial clinical trials group in which a network of researchers could address key questions in multicenter studies that would allow access to large, population-based samples;

• Clinical trials of psychosocial interventions that are conducted within routine breast cancer care in which cost and quality of life are outcome measures;

• A registry of ongoing psychosocial research/trials to assist researchers 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 psychosocial services) in the United States. The results of such a study could provide 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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