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Randomized Controlled Trial Comparing MBSR to SET in Breast Cancer Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by AHS Cancer Control Alberta.
Recruitment status was:  Active, not recruiting
ClinicalTrials.gov Identifier:
First Posted: October 19, 2006
Last Update Posted: January 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
British Columbia Cancer Agency
Information provided by:
AHS Cancer Control Alberta
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.

Condition Intervention Phase
Breast Neoplasms Behavioral: Mindfulness Meditation-Based Stress Reduction Behavioral: Supportive-Expressive Group Therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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

Resource links provided by NLM:

Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • Psychological:mood, stress, post-traumatic growth, social support, quality of life, spirituality
  • Physical:cortisol levels (stress hormone)

Secondary Outcome Measures:
  • emotional repression
  • personality
  • emotional suppression

Estimated Enrollment: 300
Study Start Date: October 2006
Estimated Study Completion Date: July 2009

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00390169

Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Sponsors and Collaborators
Canadian Breast Cancer Research Alliance
British Columbia Cancer Agency
Principal Investigator: Linda E Carlson, Ph.D AHS Cancer Control Alberta
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00390169     History of Changes
Other Study ID Numbers: 20444
CBCRA #017728
First Submitted: October 18, 2006
First Posted: October 19, 2006
Last Update Posted: January 19, 2012
Last Verified: August 2011

Keywords provided by AHS Cancer Control Alberta:
breast neoplasms

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases