A Mindfulness Meditation-Based Intervention for Younger Breast Cancer Survivors

Jonsson Comprehensive Cancer Center

Status and phase: Completed; Phase 2

Conditions: Younger Breast Cancer Survivors

Treatments: Behavioral: Mindful Awareness practices (MAPs)

Study type: Interventional

Funder types: Other

Identifiers

NCT01558258

SAC110009 (Other Identifier)

10-001799

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: Female

Ages: Under 50 years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

Mindfullness Meditation-based Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Mindful Awareness practices (MAPs)

Wait-list control group

No Intervention group

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.