Group Therapy for Primary Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00220792
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 22, 2005
National Cancer Institute (NCI)
Cummings Foundation
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Brief supportive-expressive group therapy Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Trial of Group Therapy for Breast Cancer
Study Start Date : June 1993
Study Completion Date : June 1998

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00220792

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
University of Rochester CCOP
Rochester, New York, United States, 14642
Syracuse Hem/Onc CCOP
Syracuse, New York, United States, 13210
United States, Washington
Northwest CCOP
Tacoma, Washington, United States, 98405
United States, Wisconsin
Marshfield Medical Research Foundation
Marshfield, Wisconsin, United States, 54449
Milwaukee CCOP
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Cummings Foundation
Principal Investigator: David Spiegel, MD Stanford University

Spiegel, D., Morrow, G.R., Classen, C., Riggs, G., Stott, P.B., Mudaliar, N., Pierce, H.I., Flynn, P.J., & Heard, L. (1996). Effects of group therapy on women with primary breast cancer. The Breast Journal, 2(1), 104-106.
Azarow, J., Han W.T., Koopman, C., Classen C., Morrow G.R., & Spiegel, D. (2001) Traumatic stress, pain, and self-efficacy are related to breast cancer patients’ satisfaction with care. Psychosomatic Medicine, 63, 1, 1130 Identifier: NCT00220792     History of Changes
Other Study ID Numbers: CA61309
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 22, 2005
Last Verified: September 2005

Keywords provided by Stanford University:
Primary breast cancer
support groups
mood disturbance

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases