Randomized Controlled Trial Comparing MBSR to SET in Breast Cancer Patients

Sponsor

Canadian Breast Cancer Research Alliance (Other)

Overall Status

Unknown status

CT.gov ID

NCT00390169

Collaborator

British Columbia Cancer Agency (Other)

300

Enrollment

Location

Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated 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 :

Oct 1, 2006

Study Completion Date :

Jul 1, 2009

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.