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Completed

NCT Number: NCT01422551

Facilitating Positive Adaptation to Breast Cancer

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Department of Psychology University of Miami

Coral Gables, Florida, 33124, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Stress Management

Behavioral

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

a psycho-educational control

Behavioral

a single-day psycho-educational seminar

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
1999
Primary completion
2007
Study completion
2007
First posted
Aug 24, 2011
Registry last updated
Aug 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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