Group Therapy for Primary Breast Cancer

NCT ID: NCT00220792

Last Updated: 2024-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1993-06-30
• Study Completion Date: 1998-06-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Brief supportive-expressive group therapy

Intervention Type: BEHAVIORAL

Eligibility 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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Cummings Foundation

UNKNOWN

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Principal Investigators

David Spiegel, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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

Northern New Jersey CCOP

Hackensack, New Jersey, United States

North Shore University Hospital CCOP

Manhasset, New York, United States

University of Rochester CCOP

Rochester, New York, United States

Syracuse Hem/Onc CCOP

Syracuse, New York, United States

Northwest CCOP

Tacoma, Washington, United States

Marshfield Medical Research Foundation

Marshfield, Wisconsin, United States

Milwaukee CCOP

Milwaukee, Wisconsin, United States

Countries

United States

References

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. doi: 10.1002/pon.852.

Reference Type: BACKGROUND

PMID: 15386762 (View on PubMed)

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. doi: 10.1002/pon.624.

Reference Type: BACKGROUND

PMID: 12228876 (View on PubMed)

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. doi: 10.1023/A:1016295610660.

Reference Type: BACKGROUND

PMID: 12224799 (View on PubMed)

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. doi: 10.1002/1099-1611(200101/02)10:13.0.co;2-s.

Reference Type: BACKGROUND

PMID: 11180576 (View on PubMed)

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. doi: 10.1002/(sici)1099-1611(199911/12)8:63.0.co;2-w.

Reference Type: BACKGROUND

PMID: 10607981 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9185066 (View on PubMed)

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.

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

Other Identifiers

CA61309

Identifier Type: -

Identifier Source: org_study_id