Facilitating Positive Adaptation to Breast Cancer
Status and phase
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About
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.
Full 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).
Enrollment
Sex
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Volunteers
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
Trial design
240 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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