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Facilitating Positive Adaptation to Breast Cancer

Phase 2
21 Years
75 Years
Not Enrolling
Breast Cancer

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Trial Information

Facilitating Positive Adaptation to 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).

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Outcome Measure:

change from baseline to 12 month follow-up in psychosocial adaptation (less negative affect and social disruption; more benefit finding and positive affect)

Outcome Description:

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

Outcome Time Frame:

baseline and 6 and 12 month follow-up

Safety Issue:


Principal Investigator

Michael Antoni, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Miami


United States: Institutional Review Board

Study ID:




Start Date:

September 1999

Completion Date:

August 2007

Related Keywords:

  • Breast Cancer
  • stress management intervention
  • breast cancer
  • quality of life
  • psychosocial adaptation
  • Breast Neoplasms



Department of Psychology University of Miami Coral Gables, Florida  33124