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A Multicenter Trial of Group Therapy for Breast Cancer


Phase 3
N/A
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Multicenter Trial of Group Therapy for Breast Cancer


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Principal Investigator

David Spiegel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

CA61309

NCT ID:

NCT00220792

Start Date:

June 1993

Completion Date:

June 1998

Related Keywords:

  • Breast Cancer
  • Primary breast cancer
  • support groups
  • mood disturbance
  • Breast Neoplasms

Name

Location
Metro-Minnesota CCOP St. Louis Park, Minnesota  
Marshfield Medical Research Foundation Marshfield, Wisconsin  54449
Northwest CCOP Tacoma, Washington  98405
Social Work Consultants, Inc Wichita, Kansas  67202
Kalamazoo Community Clinical Oncology Program Kalamazoo, Michigan  49007
Northern New Jersey CCOP Hackensack, New Jersey  07601
North Shore University Hospital CCOP Manhasset, New York  11030
University of Rochester CCOP Rochester, New York  14642
Syracuse Hem/Onc CCOP Syracuse, New York  13210
Milwaukee CCOP Milwaukee, Wisconsin  53215