Randomized Controlled Trial Comparing MBSR to SET in Breast Cancer Patients
This trial is active, not recruiting.
|Treatments||mindfulness meditation-based stress reduction, supportive-expressive group therapy|
|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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Psychological:mood, stress, post-traumatic growth, social support, quality of life, spirituality
Physical:cortisol levels (stress hormone)
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.
|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|
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