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A Mindfulness Meditation-Based Intervention for Younger Breast Cancer Survivors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Susan G. Komen Breast Cancer Foundation
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01558258
First received: February 17, 2012
Last updated: October 2, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Younger Breast Cancer Survivors
 Behavioral: Mindful Awareness practices (MAPs)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Mindfulness Meditation-Based Intervention for Younger Breast Cancer Survivors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • Effect of Mindful Awareness Practices on daily living. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: April 2011
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mindfullness Meditation-based Intervention
Mindfulness meditation-based intervention, is a 6-week program adapted from an existing program at Mindfulness Awareness Research Center(MARC),UCLA.
 Behavioral: Mindful Awareness practices (MAPs)
Mindfulness meditation-based intervention, is a 6-week program adapted from an existing program at Mindfulness Awareness Research Center(MARC),UCLA.
No Intervention: Wait-list control group
The wait-list control condition will control for naturally occurring changes in stress and other outcomes over the six-week intervention period. After the post-treatment assessments have been completed, those assigned to the wait-list control group will be able to participate in the MAP classes.

  Eligibility

Ages Eligible for Study:   up to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558258

Locations
United States, California
UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Susan G. Komen Breast Cancer Foundation
Investigators
Principal Investigator: Patricia Ganz, M.D. Jonsson Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01558258     History of Changes
Other Study ID Numbers: 10-001799, SAC110009
Study First Received: February 17, 2012
Last Updated: October 2, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013