Group Therapy for Primary Breast Cancer

Phase 3CompletedNCT00220792

Stanford University480 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

480

Conditions

Breast Cancer

Interventions

Brief supportive-expressive group therapyBEHAVIORAL

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: * : 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. Exclusion Criteria: * 1\) 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.

Locations (10)

Social Work Consultants, Inc

Wichita, Kansas, United States

Kalamazoo Community Clinical Oncology Program

Kalamazoo, Michigan, United States

Metro-Minnesota CCOP

Saint Louis Park, Minnesota, United States

Outcomes

Primary Outcomes

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.

Data from ClinicalTrials.gov

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