Facilitating Positive Adaptation to Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-30

Study Completion Date

2007-08-31

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.

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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).

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Cognitive Behavioral Stress Management

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

Group Type EXPERIMENTAL

Cognitive Behavioral Stress Management

Intervention Type BEHAVIORAL

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

Psycho-educational Control

a single day group-based psycho-educational seminar

Group Type ACTIVE_COMPARATOR

a psycho-educational control

Intervention Type BEHAVIORAL

a single-day psycho-educational seminar

Interventions

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Cognitive Behavioral Stress Management

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

Intervention Type BEHAVIORAL

a psycho-educational control

a single-day psycho-educational seminar

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No