Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments cognitive behavioral training, relaxation training, health education control
Sponsor University of Miami
Collaborator National Cancer Institute (NCI)
Start date December 2006
End date June 2014
Trial size 184 participants
Trial identifier NCT02103387, 20060496, 2R01CA064710

Summary

To test the effects of 2 different 5-wk stress management interventions (cognitive behavioral training or relaxation training) vs. a time-matched 5-wk health education condition on psychosocial adaptation and physiological adaptation in women being treated for breast cancer. Participants assigned to either of the stress management conditions will show improved psychosocial adaptation and physiological adaptation compared to those assigned to the health education condition.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose supportive care
Arm
(Experimental)
Cognitive Behavioral Training 5 weekly 1.5-hour sessions of group-based cognitive behavioral training
cognitive behavioral training
Cognitive Behavioral Training [CBT] (stress awareness, cognitive restructuring, coping skills training, interpersonal skills training)
(Experimental)
Relaxation Training 5 weekly 1.5-hour sessions of group-based relaxation training
relaxation training
Relaxation Training [RT] (muscle relaxation, deep breathing, guided imagery, meditation)
(Active Comparator)
Health Education Control 5 weekly 1.5 sessions of group-based health education training
health education control
Health Education control condition (information about breast cancer diagnosis and treatment, side-effect management, recurrence, physical activity and nutrition, and life after breast cancer)

Primary Outcomes

Measure
Psychosocial adaptation-Affect Balance Scale Negative Affect scores, Positive Affect scores and and Sickness Impact Scale social interaction scores
time frame: 12 month follow-up

Secondary Outcomes

Measure
Physiological Adaptation
time frame: 12 month follow-up

Eligibility Criteria

Female participants from 21 years up to 75 years old.

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

Additional Information

Official title Five Sessions Intervention to Facilitate Adaptation to Breast Cancer
Principal investigator Michael H Antoni, Ph.D.
Description The study tests the effects of two 5-wk group-based stress management interventions (Cognitive Behavioral Training [CBT] (stress awareness, cognitive restructuring, coping skills training, interpersonal skills training), Relaxation Training [RT] (muscle relaxation, deep breathing, guided imagery, meditation) vs. a time-matched 5-wk group-based Health Education Training control condition (information about breast cancer diagnosis and treatment, side-effect management, recurrence, physical activity and nutrition, and life after breast cancer) in women who have recently had surgery for breast cancer but have not yet started adjuvant therapy. The study evaluates the effects of CBT and RT on psychological adaptation (includes measures of negative adaptation [negative affect and social disruption] and positive adaptation [positive affect and benefit finding]) at 6-month and 12-month follow-up. The study also evaluates the effects of CBT and RT 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 (PBMCs).
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Miami.