Facilitating Positive Adaptation to Breast Cancer
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).
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
change from baseline to 12 month follow-up in psychosocial adaptation (less negative affect and social disruption; more benefit finding and positive affect)
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
baseline and 6 and 12 month follow-up
No
Michael Antoni, Ph.D.
Principal Investigator
University of Miami
United States: Institutional Review Board
19930536
NCT01422551
September 1999
August 2007
Name | Location |
---|---|
Department of Psychology University of Miami | Coral Gables, Florida 33124 |