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A Mindfulness Meditation-Based Intervention for Younger Breast Cancer Survivors

A Mindfulness Meditation-Based Intervention for Younger Breast Cancer Survivors

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01558258
Enrollment
71
Registered
2012-03-20
Start date
2011-04-30
Completion date
2014-11-30
Last updated
2015-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Younger Breast Cancer Survivors

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.

Interventions

Mindfulness meditation-based intervention, is a 6-week program adapted from an existing program at Mindfulness Awareness Research Center(MARC),UCLA.

Sponsors

Susan G. Komen Breast Cancer Foundation
CollaboratorOTHER
Jonsson Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Effect of Mindful Awareness Practices on daily living.6 weeksParticipants 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026