RCT of Online Mindfulness-Based Stress Reduction for Metastatic Breast Cancer Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- Feasibility of the online intervention for metastatic breast cancer patients
Study Overview
Brief Summary
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.
Detailed Description
PRIMARY OBJECTIVES:
I. To develop a novel online mindfulness-based stress reduction (MBSR) treatment for distressed metastatic breast cancer patients in the hope of reaching patients otherwise unable to participate in traditional interventions due to high symptom burden.
II. Determine the impact of the intervention on both patient self-report and biological symptom measures.
OUTLINE: Participants are randomized to 1 of 2 arms.
INTERVENTION ARM: 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 compact disc (CD).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Feasibility of the online intervention for metastatic breast cancer patients
Time Frame: At 6 weeks
Successfully completing 4 out of 6 week sessions of online intervention for distressed metastatic breast cancer patients.
Secondary Outcomes
- Improvement in depression as measured by the Brief Symptom Inventory (BSI-18)(Baseline and 6 weeks)
- Improvement in anxiety as measured by BSI-18(Baseline and 6 weeks)
- Improvement in fatigue measured with the Functional Assessment of Cancer Therapy Fatigue questionnaire(Baseline and 6 weeks)
- Improvement in sleep impairment as measured by General Sleep Disturbance Scale(Baseline and 6 weeks)
- Improvement in pain(Baseline and 6 weeks)
- Improvement in quality of life (QOL): FACT-B(Baseline 6 weeks)
- Improvement in blood pressure(Baseline and 6 weeks)
- Improvement in cancer-related biomarkers(Baseline and 6 weeks)
- Increases in mindfulness(Baseline and 6 weeks)