Facilitating Positive Adaptation to Breast Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cognitive Behavioral Stress Management 10 weekly 2-hour sessions of group-based cognitive behavioral stress management |
Behavioral: Cognitive Behavioral Stress Management
10 weekly 2-hour sessions of group-based cognitive behavioral stress management
|
| Active Comparator: Psycho-educational Control a single day group-based psycho-educational seminar |
Behavioral: a psycho-educational control
a single-day psycho-educational seminar
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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)
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Psychology University of Miami | Coral Gables | Florida | United States | 33124 |
Sponsors and Collaborators
- University of Miami
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Michael Antoni, Ph.D., University of Miami
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19930536
- R01CA064710