Breast Cancer Clinical Trial

Five Sessions Intervention to Facilitate Adaptation to Breast Cancer

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.

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Full Description

This is a randomized controlled trial comparing the effects of 5-wk group-based stress management interventions (cognitive behavioral therapy [CBT] or relaxation training [RT]) vs a time-matched 5-wk group-based health education (HE) condition on psychosocial adaptation (negative and positive mood, social disruption) and physiological adaptation (cortisol and immune function) in women with non-metastatic breast cancer who are undergoing primary treatment. Participants are recruited in the weeks after surgery and before the start of adjuvant chemotherapy or radiation, are assessed for baseline psychosocial and physiological adaptation indicators, and are then randomly allocated to either CBT, RT or HE. They are re-assessed for psychosocial and physiological adaptation at 6 and 12 month follow-up. Primary hypothesis is that women assigned to CBT or RT will show greater reductions in negative affect and social disruption, and greater increases in positive affect over time compared to women assigned to HE. Secondary hypothesis is that women assigned to CBT or RT will show greater decreases in cortisol and greater increases in immune functioning over time compared to those assigned to HE.

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Eligibility 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

Study is for people with:

Breast Cancer

Estimated Enrollment:

194

Study ID:

NCT02103387

Recruitment Status:

Completed

Sponsor:

University of Miami

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There is 1 Location for this study

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Department of Psychology
Coral Gables Florida, 33124, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

194

Study ID:

NCT02103387

Recruitment Status:

Completed

Sponsor:


University of Miami

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