This phase III trial compares the effect of the combination of mindfulness-based intervention during radiation therapy versus radiation therapy alone on the quality of life in patients with cancer. Mindfulness-based intervention is a therapy designed to improve psychological well-being through reduced anxiety, depressive symptoms, and distress, and improved mood.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04303013.
PRIMARY OBJECTIVE:
I. To evaluate the effectiveness of a mindfulness-based intervention (MBI) on subjective reports of wellness including emotional, physical, functional, and social domains assessed via the Functional Assessment of Cancer Therapy General (FACT-G) during and after radiotherapy for the treatment of cancer.
SECONDARY OBJECTIVES:
I. To evaluate the effectiveness of MBI on patient reported fatigue, relaxation, and wellness assessed weekly via the LASA-6 and single-item relaxation during radiation question.
II. To evaluate the 3-month and 1-year effectiveness of MBI on subjective reports of wellness including emotional, physical, functional, and social domains after radiotherapy for the treatment of cancer assessed via the FACT-G, Patient Reported Outcomes Measurement Information System (PROMIS) 10, and Linear Analogue Self-Assessment (LASA)-6.
EXPLORATORY OBJECTIVES:
I. To determine the degree of compliance with MBI.
II. To evaluate the short-term effect of MBI on physician-reported acute radiation toxicities.
III. To evaluate patient-reported sense of benefit of MBI sessions via the Was It Worth It (WIWI) and end of treatment questionnaire specific to the MBI arm.
IV. To evaluate whether MBI reduces the frequency of patients taking narcotic pain medication or anti-anxiety medication (schedule II-IV controlled substances) during radiation therapy (RT).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients attend mindfulness-based intervention session over 30 minutes every week during radiation therapy.
ARM II: Patients continue radiation treatment per standard of care.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationMayo Clinic in Rochester
Principal InvestigatorKimberly S. Corbin