Group Therapy for Primary Breast Cancer

NCT00220792 | Completed Phase 3

• 1 other identifier: CA61309
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 10

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.

Conditions

Breast Cancer

Keywords

Primary breast cancer; support groups; mood disturbance

Outcome Measures

Primary Outcomes (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.

Interventions

Brief supportive-expressive group therapy BEHAVIORAL

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• : 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Stanford University: lead
• National Cancer Institute (NCI): collaborator
• Cummings Foundation: collaborator

Study Sites (10)

Social Work Consultants, Inc

Wichita, Kansas, 67202, United States

Location

Kalamazoo Community Clinical Oncology Program

Kalamazoo, Michigan, 49007, United States

Location

Metro-Minnesota CCOP

Saint Louis Park, Minnesota, 55416, United States

Location

Northern New Jersey CCOP

Hackensack, New Jersey, 07601, United States

Location

North Shore University Hospital CCOP

Manhasset, New York, 11030, United States

Location

University of Rochester CCOP

Rochester, New York, 14642, United States

Location

Syracuse Hem/Onc CCOP

Syracuse, New York, 13210, United States

Location

Northwest CCOP

Tacoma, Washington, 98405, United States

Location

Marshfield Medical Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

Milwaukee CCOP

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (8)

• 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.

  PMID: 15386762 BACKGROUND

• 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.

  PMID: 12228876 BACKGROUND

• 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.

  PMID: 12224799 BACKGROUND

• 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.

  PMID: 11180576 BACKGROUND

• 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.

  PMID: 10607981 BACKGROUND

• 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.

  PMID: 9185066 BACKGROUND

• 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.

  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

  BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• David Spiegel, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 22, 2005
• Study Start: June 1, 1993
• Study Completion: June 1, 1998
• Last Updated: August 26, 2024

Record last verified: 2024-08

Locations

US (10)