Younger Breast Cancer Survivors Clinical Trial
Official title:
A Mindfulness Meditation-Based Intervention for Younger Breast Cancer Survivors
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.
| Status | Completed |
| Enrollment | 71 |
| Est. completion date | November 2014 |
| Est. primary completion date | February 2014 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | N/A to 50 Years |
| Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| United States | UCLA | Los Angeles | California |
| Lead Sponsor | Collaborator |
|---|---|
| Jonsson Comprehensive Cancer Center | Susan G. Komen Breast Cancer Foundation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Effect of Mindful Awareness Practices on daily living. | 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. | 6 weeks | No |