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Sponsors and Collaborators: |
Stanford University National Cancer Institute (NCI) Cummings Foundation |
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Information provided by: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00220792 |
The purpose of this study is to determine whether women with primary breast cancer who were randomly assigned to receive a brief group therapy would show a greater reduction in mood disturbance over time compared to those randomized to the control condition. We also hypothesized that women who were highly distressed at baseline would show the greatest benefit from participating in a support group, and that therapists with more training and experience would be most effective in reducing distress.
Condition | Intervention | Phase |
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Breast Cancer |
Behavioral: Brief supportive-expressive group therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study |
Official Title: | A Multicenter Trial of Group Therapy for Breast Cancer |
Estimated Enrollment: | 480 |
Study Start Date: | June 1993 |
Estimated Study Completion Date: | June 1998 |
Breast cancer patients often experience significant psychological distress after diagnosis and during initial treatment. Group interventions for cancer patients have been shown to improve psychological adjustment. The tests of efficacy for these interventions have typically taken place in university settings using highly developed models of intervention. Our aim was to test our supportive-expressive model in community oncology practices utilizing personnel already working with these populations. To conduct this study of group therapy for primary breast cancer patients, we developed a brief version of the supportive-expressive model (Classen et al., 1993). Our first aim was to test the efficacy of this intervention for reducing mood disturbance for women who received the intervention compared to a control group. A second aim was to examine who was most likely to benefit from the intervention. A third aim was to see if this method could be taught efficiently and effectively to oncology nurses and mental health professionals.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Kansas | |
Social Work Consultants, Inc | |
Wichita, Kansas, United States, 67202 | |
United States, Michigan | |
Kalamazoo Community Clinical Oncology Program | |
Kalamazoo, Michigan, United States, 49007 | |
United States, Minnesota | |
Metro-Minnesota CCOP | |
St. Louis Park, Minnesota, United States, 55416 | |
United States, New Jersey | |
Northern New Jersey CCOP | |
Hackensack, New Jersey, United States, 07601 | |
United States, New York | |
North Shore University Hospital CCOP | |
Manhasset, New York, United States, 11030 | |
Syracuse Hem/Onc CCOP | |
Syracuse, New York, United States, 13210 | |
University of Rochester CCOP | |
Rochester, New York, United States, 14642 | |
United States, Washington | |
Northwest CCOP | |
Tacoma, Washington, United States, 98405 | |
United States, Wisconsin | |
Milwaukee CCOP | |
Milwaukee, Wisconsin, United States, 53215 | |
Marshfield Medical Research Foundation | |
Marshfield, Wisconsin, United States, 54449 |
Principal Investigator: | David Spiegel, MD | Stanford University |
Study ID Numbers: | CA61309 |
Study First Received: | September 15, 2005 |
Last Updated: | September 15, 2005 |
ClinicalTrials.gov Identifier: | NCT00220792 History of Changes |
Health Authority: | United States: Institutional Review Board |
Primary breast cancer support groups mood disturbance |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |