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Facilitating Positive Adaptation to Breast Cancer

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ClinicalTrials.gov Identifier: NCT01422551
Recruitment Status : Completed
First Posted : August 24, 2011
Last Update Posted : August 24, 2011
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Michael H. Antoni, 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Cognitive Behavioral Stress Management Behavioral: a psycho-educational control Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Facilitating Positive Adaptation to Breast Cancer
Study Start Date : September 1999
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cognitive Behavioral Stress Management
10 weekly 2-hour sessions of group-based cognitive behavioral stress management
Behavioral: Cognitive Behavioral Stress Management
10 weekly 2-hour sessions of group-based cognitive behavioral stress management
Active Comparator: Psycho-educational Control
a single day group-based psycho-educational seminar
Behavioral: a psycho-educational control
a single-day psycho-educational seminar



Primary Outcome Measures :
  1. change from baseline to 12 month follow-up in psychosocial adaptation (less negative affect and social disruption; more benefit finding and positive affect) [ Time Frame: 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 :
  1. change from baseline to 12 months in physiological adaptation (decreased serum cortisol and increased Th1 cytokine production) [ Time Frame: 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)



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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01422551


Locations
United States, Florida
Department of Psychology University of Miami
Coral Gables, Florida, United States, 33124
Sponsors and Collaborators
University of Miami
National Cancer Institute (NCI)
Investigators
Principal Investigator: Michael Antoni, Ph.D. University of Miami

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Michael H. Antoni, Principle Investigator, University of Miami
ClinicalTrials.gov Identifier: NCT01422551     History of Changes
Other Study ID Numbers: 19930536
R01CA064710 ( U.S. NIH Grant/Contract )
First Posted: August 24, 2011    Key Record Dates
Last Update Posted: August 24, 2011
Last Verified: August 2011

Keywords provided by Michael H. Antoni, University of Miami:
stress management intervention
breast cancer
quality of life
psychosocial adaptation

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases