A Mindfulness Meditation-Based Intervention for Younger Breast Cancer Survivors

NCT01558258 | Completed Phase 2

• 2 other identifiers: 10-001799SAC110009
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Younger Breast Cancer Survivors

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Study Arms (2)

Mindfullness Meditation-based Intervention

EXPERIMENTAL

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)

Wait-list control group

NO INTERVENTION

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.

Interventions

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.

Mindfullness Meditation-based Intervention

Eligibility Criteria

• Age: Up to 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• have a breast cancer recurrence, metastasis, or another cancer diagnosis (excluding non-melanoma skin cancer
• unable to commit to intervention schedule.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Susan G. Komen Breast Cancer Foundation: collaborator

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

Study Officials

• Patricia Ganz, M.D.

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2012
• First Posted: March 20, 2012
• Study Start: April 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: November 1, 2014
• Last Updated: April 10, 2015

Record last verified: 2015-04

Locations

US (1)