A Mindfulness Meditation-Based Intervention for Younger Breast Cancer Survivors

NCT ID: NCT01558258

Last Updated: 2015-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2014-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindful Awareness practices (MAPs)

Intervention Type: BEHAVIORAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Susan G. Komen Breast Cancer Foundation

OTHER

Sponsor Role: collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia Ganz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Jonsson Comprehensive Cancer Center

Locations

UCLA

Los Angeles, California, United States

Countries

United States

Other Identifiers

SAC110009

Identifier Type: OTHER

Identifier Source: secondary_id

10-001799

Identifier Type: -

Identifier Source: org_study_id