Breast Cancer
Conditions
Keywords
stress management intervention, breast cancer, quality of life, psychosocial adaptation
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).
Interventions
BEHAVIORALCognitive Behavioral Stress Management
10 weekly 2-hour sessions of group-based cognitive behavioral stress management
BEHAVIORALa psycho-educational control
a single-day psycho-educational seminar
Sponsors
National Cancer Institute (NCI)
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline to 12 month follow-up in psychosocial adaptation (less negative affect and social disruption; more benefit finding and positive affect) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | decreased PM levels of serum cortisol and increased Th1 (interleukin-2, interferon-gamma) cytokine production following anti-CD3 stimulation of peripheral blood mononuclear cells (PBMCs) |
Countries
United States
Outcome results
None listed