Facilitating Positive Adaptation to Breast Cancer

University of Miami240 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

240

Conditions

Breast Cancer

Interventions

Cognitive Behavioral Stress ManagementBEHAVIORAL

10 weekly 2-hour sessions of group-based cognitive behavioral stress management

a psycho-educational controlBEHAVIORAL

a single-day psycho-educational seminar

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Psychology University of Miami

Coral Gables, Florida, United States

Outcomes

Primary Outcomes

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

Time frame: baseline and 6 and 12 month follow-up

Secondary Outcomes

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)

Time frame: baseline and 6 and 12 months follow-up

Data from ClinicalTrials.gov

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