Randomized Controlled Trial Comparing MBSR to SET in Breast Cancer Patients

Canadian Breast Cancer Research Alliance300 enrolled

Overview

This study will compare three standard treatment programs commonly offered to patients with breast cancer. The three programs being compared are 1) Mindfulness Meditation-Based Stress Reduction (MBSR), 2)Supportive- Expressive Group Therapy (SET), and 3) A one day stress-management seminar. The purpose of this study is to determine if these three treatments have different effects on psychological well-being, the immune system, and the amount of stress hormones in the bloodstream.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

300

Conditions

Breast Neoplasms

Interventions

Mindfulness Meditation-Based Stress ReductionBEHAVIORAL

Supportive-Expressive Group TherapyBEHAVIORAL

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Study participants must be women diagnosed with Stage I, II, or III breast cancer within the previous 18 months, have completed all treatments with the exception of hormonal therapy at least three months previously, over the age of 18, and have a score of 13 or higher on the BSI-18. Previous meditation/yoga experience is allowed but will be recorded. Exclusion Criteria: * Participants must not have a concurrent DSM-IV diagnosis of psychosis, substance abuse, bipolar disorder, or active suicidality (as assessed by structured clinical interview), must not be currently using psychotropic medications (antipsychotics, antidepressants, anxiolytics), have a concurrent autoimmune disorder, or have participated previously in MBSR or SET group.

Locations (1)

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Outcomes

Primary Outcomes

Psychological:mood, stress, post-traumatic growth, social support, quality of life, spirituality

Physical:cortisol levels (stress hormone)

Secondary Outcomes

emotional repression

personality

emotional suppression

Data from ClinicalTrials.gov

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