Facilitating Positive Adaptation to Breast Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- University of Miami
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- change from baseline to 12 month follow-up in psychosocial adaptation (less negative affect and social disruption; more benefit finding and positive affect)
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
The purpose of this study is to test the effects of a 10-wk cognitive behavioral stress management (CBSM) intervention vs. a single-day psycho-educational seminar on psychosocial adaptation and physiological adaptation in women being treated for stage I-III breast cancer.
Detailed Description
The study tests the effects of a 10-wk group-based cognitive behavioral stress management (CBSM) intervention (relaxation, stress awareness, cognitive restructuring, coping skills training, interpersonal skills training) versus a single-day psycho-educational seminar (general information about stress and coping) in women who have recently had surgery for breast cancer but have not yet started adjuvant therapy. The study evaluates the effects of CBSM on psychosocial adaptation (includes measures of negative adaptation \[distress and social disruption\] and positive adaptation \[benefit finding and positive affect\]) at 6-month and 12-month follow-up. The study also evaluates the effects of CBSM on physiological adaptation (includes levels of PM serum cortisol and T-helper-type 1 (Th1) cytokine \[interleukin-2, IL-2, and interferon-gamma, IFN-g, production after anti-CD3 stimulation of peripheral blood mononuclear cells (PBMC).
Investigators
Michael H. Antoni
Principle Investigator
University of Miami
Eligibility Criteria
Inclusion Criteria
- •women diagnosed with breast cancer at stage III or below who had recently undergone lumpectomy or mastectomy
Exclusion Criteria
- •prior cancer,
- •prior psychiatric treatment for a serious disorder (e.g., psychosis, suicidality),
- •lack of fluency in English and had begun adjuvant therapy at time of first assessment
Outcomes
Primary Outcomes
change from baseline to 12 month follow-up in psychosocial adaptation (less negative affect and social disruption; more benefit finding and positive affect)
Time Frame: baseline and 6 and 12 month follow-up
changes in a composite composed of negative affect measures plus a measure of social disruption plus a measure of benefit finding plus a measure of positive affect
Secondary Outcomes
- change from baseline to 12 months in physiological adaptation (decreased serum cortisol and increased Th1 cytokine production)(baseline and 6 and 12 months follow-up)