Facilitating Positive Adaptation to Breast Cancer

Study Overview
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Brief Summary
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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
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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).

Official Title
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Facilitating Positive Adaptation to Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Stress Management
* Behavioral: a psycho-educational control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral Stress Management<br>10 weekly 2-hour sessions of group-based cognitive behavioral stress management | Behavioral: Cognitive Behavioral Stress Management<br>* 10 weekly 2-hour sessions of group-based cognitive behavioral stress management<br>|
| Active Comparator: Psycho-educational Control<br>a single day group-based psycho-educational seminar | Behavioral: a psycho-educational control<br>* a single-day psycho-educational seminar<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline to 12 months in physiological adaptation (decreased serum cortisol and increased Th1 cytokine production) | 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) | baseline and 6 and 12 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stress management intervention, breast cancer, quality of life, psychosocial adaptation