Randomized Controlled Trial Comparing MBSR to SET in Breast Cancer Patients - Full Text View

Sponsors and Collaborators:	Canadian Breast Cancer Research Alliance BC Cancer Agency
Information provided by:	Alberta Cancer Board
ClinicalTrials.gov Identifier:	NCT00390169

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 III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Alberta Cancer Board:

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

Contacts

Contact: Linda E Carlson, Ph.D

403-355-3209

lcarlso@ucalgary.ca

Locations

Canada, Alberta
Tom Baker Cancer Centre	Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Rachel Syme, PhD 403-521-3388 rachelsy@cancerboard.ab.ca
Principal Investigator: Linda E Carlson, PhD

Sponsors and Collaborators

Canadian Breast Cancer Research Alliance

BC Cancer Agency

Investigators

Principal Investigator:

Linda E Carlson, Ph.D

Alberta Cancer Board

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Carlson LE, Garland SN. Impact of mindfulness-based stress reduction (MBSR) on sleep, mood, stress and fatigue symptoms in cancer outpatients. Int J Behav Med. 2005;12(4):278-85.

Carlson LE, Speca M, Patel KD, Goodey E. Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress and levels of cortisol, dehydroepiandrosterone sulfate (DHEAS) and melatonin in breast and prostate cancer outpatients. Psychoneuroendocrinology. 2004 May;29(4):448-74.

Carlson LE, Speca M, Patel KD, Goodey E. Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress, and immune parameters in breast and prostate cancer outpatients. Psychosom Med. 2003 Jul-Aug;65(4):571-81.

Study ID Numbers:	20444, CBCRA #017728
Study First Received:	October 18, 2006
Last Updated:	May 5, 2009
ClinicalTrials.gov Identifier:	NCT00390169 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Alberta Cancer Board:

breast neoplasms
stress
personality
psychology

Study placed in the following topic categories:

Skin Diseases
Stress
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009