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Group Therapy for Primary Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Cummings Foundation
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00220792
First received: September 15, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cummings Foundation
Investigators
Principal Investigator: David Spiegel, MD Stanford University
  More Information

Publications:
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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 20, 2014