Completed

NCT Number: NCT01558258

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Younger Breast Cancer Survivors

Age range

Up to 50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

UCLA

Los Angeles, California, 90095, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindful Awareness practices (MAPs)

Behavioral

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

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.

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Collaborators

Susan G. Komen Breast Cancer Foundation

Registry information

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Mar 20, 2012
Registry last updated: Apr 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.