Randomized Controlled Trial Comparing MBSR to SET in Breast Cancer Patients

Canadian Breast Cancer Research Alliance

Status and phase: Unknown; Phase 3

Conditions: Breast Neoplasms

Treatments: Behavioral: Mindfulness Meditation-Based Stress Reduction; Behavioral: Supportive-Expressive Group Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00390169

20444

CBCRA #017728

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.