Group Therapy for Primary Breast Cancer - Full Text View

Purpose

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
Breast Cancer	Behavioral: Brief supportive-expressive group therapy	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multicenter Trial of Group Therapy for Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

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.

Estimated Enrollment:	480
Study Start Date:	June 1993
Estimated Study Completion Date:	June 1998

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220792

Locations

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

Investigators

Principal Investigator:

David Spiegel, MD

Stanford University

More Information

Publications:

Han WT, Collie K, Koopman C, Azarow J, Classen C, Morrow GR, Michel B, Brennan-O'Neill E, Spiegel D. Breast cancer and problems with medical interactions: relationships with traumatic stress, emotional self-efficacy, and social support. Psychooncology. 2005 Apr;14(4):318-30.

Fobair P, Koopman C, DiMiceli S, O'Hanlan K, Butler LD, Classen C, Drooker N, Davids HR, Loulan J, Wallsten D, Spiegel D. Psychosocial intervention for lesbians with primary breast cancer. Psychooncology. 2002 Sep-Oct;11(5):427-38.

Koopman C, Butler LD, Classen C, Giese-Davis J, Morrow GR, Westendorf J, Banerjee T, Spiegel D. Traumatic stress symptoms among women with recently diagnosed primary breast cancer. J Trauma Stress. 2002 Aug;15(4):277-87.

Fobair P, O'Hanlan K, Koopman C, Classen C, Dimiceli S, Drooker N, Warner D, Davids H, Loulan J, Wallsten D, Goffinet D, Morrow G, Spiegel D. Comparison of lesbian and heterosexual women's response to newly diagnosed breast cancer. Psychooncology. 2001 Jan-Feb;10(1):40-51.

Spiegel D, Morrow GR, Classen C, Raubertas R, Stott PB, Mudaliar N, Pierce HI, Flynn PJ, Heard L, Riggs G. Group psychotherapy for recently diagnosed breast cancer patients: a multicenter feasibility study. Psychooncology. 1999 Nov-Dec;8(6):482-93.

Classen C, Abramson S, Angell K, Atkinson A, Desch C, Vinciguerra VP, Rosenbluth RJ, Kirshner JJ, Hart R, Morrow G, Spiegel D. Effectiveness of a training program for enhancing therapists' understanding of the supportive-expressive treatment model for breast cancer groups. J Psychother Pract Res. 1997 Summer;6(3):211-8.

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

ClinicalTrials.gov Identifier:	NCT00220792 History of Changes
Other Study ID Numbers:	CA61309
Study First Received:	September 15, 2005
Last Updated:	September 15, 2005
Health Authority:	United States: Institutional Review Board

Keywords provided by Stanford University:

Primary breast cancer
support groups
mood disturbance

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013