Group Therapy for Primary Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00220792
- Lead Sponsor
- Stanford University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 480
- : 1) diagnosis of primary, biopsy-proven breast cancer, stages I through IIIA; 2) diagnosis occurred no more than 12 months prior to recruitment; 3) completion of initial surgical treatment; and 4) no detectable disease present.
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- evidence of metastases beyond adjacent lymph nodes, including chest wall involvement, bone or viscera; 2) recurrence of the cancer prior to randomization; 3) diagnosis of other cancers (except for basal cell or squamous cell carcinoma of the skin or in situ cervical cancer) within the past 10 years; 4) any other major medical problems likely to limit life expectancy to less than 10 years; 5) a history of major psychiatric illness for which the patient was hospitalized or medicated, except for a diagnosis of depression or anxiety treated for a period of less than one year; and 6) attendance at a cancer support group for more than two months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Rate of change in mood disturbance assessed by the Profile of Mood States at baseline, 3 mo, 6 mo, 12 mo, 18 mo and 24 mo.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Kalamazoo Community Clinical Oncology Program
🇺🇸Kalamazoo, Michigan, United States
Northern New Jersey CCOP
🇺🇸Hackensack, New Jersey, United States
Marshfield Medical Research Foundation
🇺🇸Marshfield, Wisconsin, United States
Syracuse Hem/Onc CCOP
🇺🇸Syracuse, New York, United States
Northwest CCOP
🇺🇸Tacoma, Washington, United States
North Shore University Hospital CCOP
🇺🇸Manhasset, New York, United States
Metro-Minnesota CCOP
🇺🇸Saint Louis Park, Minnesota, United States
Social Work Consultants, Inc
🇺🇸Wichita, Kansas, United States
Milwaukee CCOP
🇺🇸Milwaukee, Wisconsin, United States
University of Rochester CCOP
🇺🇸Rochester, New York, United States