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

February 17, 2012
October 2, 2012
April 2011
February 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01558258 on ClinicalTrials.gov Archive Site
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A Mindfulness Meditation-Based Intervention for Younger Breast Cancer Survivors
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Younger Breast Cancer Survivors
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.
  • 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.
    Intervention: Behavioral: Mindful Awareness practices (MAPs)
  • 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
Not Provided
February 2014   (final data collection date for primary outcome measure)

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.
Female
up to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01558258
10-001799, SAC110009
No
Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center
Susan G. Komen Breast Cancer Foundation
Principal Investigator: Patricia Ganz, M.D. Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP