Randomized Controlled Trial Comparing MBSR to SET in Breast Cancer Patients

Randomized Controlled Trial Comparing Mindfulness-Based Stress Reduction (MBSR) to Supportive-Expressive Therapy (SET) on Psychological and Biological Outcomes in Breast Cancer Patients

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00390169

Enrollment

300

Registered

2006-10-19

Start date

2006-10-31

Completion date

2009-07-31

Last updated

2012-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

breast neoplasms, stress, personality, psychology

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.

Interventions

BEHAVIORALMindfulness Meditation-Based Stress Reduction

BEHAVIORALSupportive-Expressive Group Therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Psychological:mood, stress, post-traumatic growth, social support, quality of life, spirituality	—
Physical:cortisol levels (stress hormone)	—

Secondary

Measure	Time frame
personality	—
emotional suppression	—
emotional repression	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026