Clinical trial · Interventional
Mindfulness-Based Stress Reduction in Helping Participants With Metastatic Breast Cancer
RCT of Online Mindfulness-Based Stress Reduction for Metastatic Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized trial studies how well a mindfulness-based stress reduction program helps participants with breast cancer that has spread to other places in the body. A cancer diagnosis is a life-changing and highly stressful event for most people, often resulting in marked declines in quality of life both during and after treatment. There are approximately 3 million women living with a history of invasive breast cancer in the U.S., with at least 150,000 living with metastatic disease. Patient preferences suggest a high need for complementary and alternative medicine interventions to address these chronic symptoms. Mindfulness-based stress reduction programs may help women living with metastatic breast cancer manage symptoms related to cancer treatment and improve quality of life.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IV Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Meditation-Based Stress Reduction Program | Behavioral | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Control (online sessions, content manual, CD after 6 weeks)
- description
- Participants randomized to the wait-list control condition complete the online intervention as in the intervention arm after the initial 6-week period has ended.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Behavioral: Meditation-Based Stress Reduction Program
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- type
- EXPERIMENTAL
- label
- Intervention (online sessions, content manual, relaxation CD)
- description
- Participants receive online group sessions over 60 minutes for 6 weeks, including 15 minutes of practice on that session's topic and daily meditation or yoga for 45 minutes. At the conclusion of the study period participants participate in mindfulness meditation over 3 hours. Participants also receive a content manual and relaxation CD.
- interventionNames
- Other: Laboratory Biomarker Analysis
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * A diagnosis of metastatic breast cancer within the past 5 years and treated at Roswell Park Cancer Institute (RPCI) * Ability to read and understand English * Current distress score of 4+ on the National Comprehensive Cancer Network (NCCN) distress thermometer * Access to an Internet connection with own device (computer, tablet, smartphone, etc.) * Patient not currently involved in an ongoing psychological intervention * If taking prescribed medication for mood or anxiety disorder, dosage has been consistent for prior 3 months Exclusion Criteria: * Unable to speak and understand English * Prior or current experience with mindfulness-based practice * Diagnosis of a psychotic disorder, bipolar disorder, substance abuse disorder, or reported suicidality * Current involvement in any other psychological treatment (excluding medication) during study duration * Currently being treated for another cancer diagnosis other than metastatic breast cancer
References
Publications (0)
Data not yet available