Clinical trial NCT03683147: Mindfulness-Based Stress Reduction in Helping Participants With Metastatic Breast Cancer
Official title: RCT of Online Mindfulness-Based Stress Reduction for Metastatic Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stage IV Breast Cancer
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

CONTROL ARM: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the online intervention for metastatic breast cancer patients
timeFrame: At 6 weeks
Secondary outcomes:
measure: Improvement in depression as measured by the Brief Symptom Inventory (BSI-18)
timeFrame: Baseline and 6 weeks
measure: Improvement in anxiety as measured by BSI-18
timeFrame: Baseline and 6 weeks
measure: Improvement in fatigue measured with the Functional Assessment of Cancer Therapy Fatigue questionnaire
timeFrame: Baseline and 6 weeks
measure: Improvement in sleep impairment as measured by General Sleep Disturbance Scale
timeFrame: Baseline and 6 weeks
measure: Improvement in pain
timeFrame: Baseline and 6 weeks
measure: Improvement in quality of life (QOL): FACT-B
timeFrame: Baseline 6 weeks
measure: Improvement in blood pressure
timeFrame: Baseline and 6 weeks
measure: Improvement in cancer-related biomarkers
timeFrame: Baseline and 6 weeks
measure: Increases in mindfulness
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Chi-Chen Hong, PhD
role: PRINCIPAL_INVESTIGATOR
References: