Text Size

Randomized Controlled Trial Comparing MBSR to SET in Breast Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
British Columbia Cancer Agency
Information provided by:
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00390169
First received: October 18, 2006
Last updated: January 18, 2012
Last verified: August 2011
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Alberta Health Services:

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00390169

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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00390169     History of Changes
Other Study ID Numbers: 20444, CBCRA #017728
Study First Received: October 18, 2006
Last Updated: January 18, 2012
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
breast neoplasms
stress
personality
psychology

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

ClinicalTrials.gov processed this record on May 16, 2013