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A Mindfulness Meditation-Based Intervention for Younger Breast Cancer Survivors

Primary Purpose

Younger Breast Cancer Survivors

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mindful Awareness practices (MAPs)
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Younger Breast Cancer Survivors

Eligibility Criteria

undefined - 50 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mindfullness Meditation-based Intervention

Wait-list control group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 17, 2012
Last Updated
April 8, 2015
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Susan G. Komen Breast Cancer Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01558258
Brief Title
A Mindfulness Meditation-Based Intervention for Younger Breast Cancer Survivors
Official Title
A Mindfulness Meditation-Based Intervention for Younger Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Susan G. Komen Breast Cancer Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Younger Breast Cancer Survivors

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfullness Meditation-based Intervention
Arm Type
Experimental
Arm Description
Mindfulness meditation-based intervention, is a 6-week program adapted from an existing program at Mindfulness Awareness Research Center(MARC),UCLA.
Arm Title
Wait-list control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindful Awareness practices (MAPs)
Intervention Description
Mindfulness meditation-based intervention, is a 6-week program adapted from an existing program at Mindfulness Awareness Research Center(MARC),UCLA.
Primary Outcome Measure Information:
Title
Effect of Mindful Awareness Practices on daily living.
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Ganz, M.D.
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Mindfulness Meditation-Based Intervention for Younger Breast Cancer Survivors

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