Mindfulness-Based Stress Reduction in Helping Participants With Metastatic Breast Cancer

Roswell Park Comprehensive Cancer Center

Status: Completed

Conditions: Stage IV Breast Cancer

Treatments: Other: Quality-of-Life Assessment; Behavioral: Meditation-Based Stress Reduction Program; Other: Questionnaire Administration; Other: Laboratory Biomarker Analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT03683147

I 50317 (Other Identifier)

NCI-2018-00453 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Control (online sessions, content manual, CD after 6 weeks)

Experimental group

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.

Treatment:

Other: Laboratory Biomarker Analysis

Other: Questionnaire Administration

Behavioral: Meditation-Based Stress Reduction Program

Other: Quality-of-Life Assessment

Intervention (online sessions, content manual, relaxation CD)

Experimental group

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.

Treatment:

Other: Laboratory Biomarker Analysis

Other: Questionnaire Administration

Behavioral: Meditation-Based Stress Reduction Program

Other: Quality-of-Life Assessment