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Clinical Trials/NCT01558258
NCT01558258
Completed
Phase 2

A Mindfulness Meditation-Based Intervention for Younger Breast Cancer Survivors

Jonsson Comprehensive Cancer Center1 site in 1 country71 target enrollmentApril 2011

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Younger Breast Cancer Survivors
Sponsor
Jonsson Comprehensive Cancer Center
Enrollment
71
Locations
1
Primary Endpoint
Effect of Mindful Awareness Practices on daily living.
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Younger women with breast cancer experience substantially greater distress and depressive symptoms than older women. These symptoms can hamper recovery and healthy behaviors that can reduce the risk of recurrence and/or other chronic diseases. The primary objective of this study is to evaluate the feasibility and preliminary efficacy of a mindfulness meditation-based intervention for this at-risk group of women. The investigators hypothesize that a structured program of mindfulness meditation will lead to significant improvements in psychological well-being (i.e., depression, stress), with corresponding improvements in health behaviors and biomarkers of cancer risk, in women diagnosed with breast cancer, prior to age 50. The investigators will also examine mechanisms for intervention effects, including increased mindfulness and ability to relax.

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
November 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • women diagnosed with early, resectable breast cancer (Stage 0, I, II, or III) prior to age 50
  • have completed treatment with surgery, radiation, and/or chemotherapy at least 3 months previously.

Exclusion Criteria

  • have a breast cancer recurrence, metastasis, or another cancer diagnosis (excluding non-melanoma skin cancer
  • unable to commit to intervention schedule.

Outcomes

Primary Outcomes

Effect of Mindful Awareness Practices on daily living.

Time Frame: 6 weeks

Participants meet for 6 weekly, 2hr group sessions that include presentation of theoretical materials on mindfulness,relaxation,and mind-body connection;experiential practice of meditation and gentle yoga;psycho-educational component for cancer survivors,and group process focused on solving problems concerning impediments to effective practice.Participants will be instructed to practice mindfulness techniques on a daily basis. Daily diaries will be kept by participants to record practice time, mood assessments, and self-reported questions on benefits and barriers to practicing.

Study Sites (1)

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