Facilitating Positive Adaptation to Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael H. Antoni, University of Miami
ClinicalTrials.gov Identifier:
NCT01422551
First received: August 21, 2011
Last updated: August 22, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Breast Cancer
Behavioral: Cognitive Behavioral Stress Management
Behavioral: a psycho-educational control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Facilitating Positive Adaptation to Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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)


Enrollment: 240
Study Start Date: September 1999
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01422551

Locations
United States, Florida
Department of Psychology University of Miami
Coral Gables, Florida, United States, 33124
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Michael Antoni, Ph.D. University of Miami
  More Information

Publications:
Additional 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
Study First Received: August 21, 2011
Last Updated: August 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on July 20, 2014