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Randomized Controlled Trial Comparing MBSR to SET in Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT00390169
Recruitment Status : Unknown
Verified August 2011 by AHS Cancer Control Alberta.
Recruitment status was:  Active, not recruiting
First Posted : October 19, 2006
Last Update Posted : January 19, 2012
Sponsor:
Collaborator:
British Columbia Cancer Agency
Information provided by:
AHS Cancer Control Alberta

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Neoplasms Behavioral: Mindfulness Meditation-Based Stress Reduction Behavioral: Supportive-Expressive Group Therapy Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
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
Study Start Date : October 2006
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources




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

Secondary Outcome Measures :
  1. emotional repression
  2. personality
  3. emotional suppression


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
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.

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


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 AHS Cancer Control Alberta

Additional Information:
Publications:
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 Posted: October 19, 2006    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: August 2011

Keywords provided by AHS Cancer Control Alberta:
breast neoplasms
stress
personality
psychology

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