Facilitating Positive Adaptation to Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Cognitive Behavioral Stress Management; Behavioral: a psycho-educational control

• Registration Number: NCT01422551
• Lead Sponsor: University of Miami

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).

Study Timeline

• Study Start: 1999-09
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2011-08
• Study First Submitted: 2011-08-21
• Study First Submitted QC: 2011-08-22
• Last Update Submitted: 2011-08-22
• Study First Posted: 2011-08-24
• Last Update Posted: 2011-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral Stress Management	Cognitive Behavioral Stress Management	10 weekly 2-hour sessions of group-based cognitive behavioral stress management
Psycho-educational Control	a psycho-educational control	a single day group-based psycho-educational seminar

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Department of Psychology University of Miami; 🇺🇸 Coral Gables, Florida, United States