This trial is active, not recruiting.

Condition breast neoplasms
Treatments mindfulness meditation-based stress reduction, supportive-expressive group therapy
Phase phase 3
Sponsor Canadian Breast Cancer Research Alliance
Collaborator British Columbia Cancer Agency
Start date October 2006
End date July 2009
Trial size 300 participants
Trial identifier NCT00390169, 20444, CBCRA #017728


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label

Primary Outcomes

Psychological:mood, stress, post-traumatic growth, social support, quality of life, spirituality
time frame:
Physical:cortisol levels (stress hormone)
time frame:

Secondary Outcomes

emotional repression
time frame:
time frame:
emotional suppression
time frame:

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title Randomized Controlled Trial Comparing Mindfulness-Based Stress Reduction (MBSR) to Supportive-Expressive Therapy (SET) on Psychological and Biological Outcomes in Breast Cancer Patients
Principal investigator Linda E Carlson, Ph.D
Trial information was received from ClinicalTrials.gov and was last updated in January 2012.
Information provided to ClinicalTrials.gov by AHS Cancer Control Alberta.