This clinical 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03683147.
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). Additionally patients undergo blood sample collection on study.
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. Additionally patients undergo blood sample collection on study.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationRoswell Park Cancer Institute
Principal InvestigatorChi-Chen Hong
