This phase II trial evaluates a mindfulness intervention (Mindfulness-Oriented Recovery Enhancement [MORE]) for relieving chronic pain in cancer patients. Pain is one of the most reported symptoms among cancer survivors and one of the most common long-term side effects of cancer treatment. Mindfulness-based interventions are therapeutic programs that use mindfulness meditation practices to encourage acceptance of thoughts, emotions, and body sensations. Research has shown that mindfulness-based interventions are useful for treating chronic pain in the general population, but research on mindfulness-based interventions in cancer survivors remains limited. The MORE intervention may relieve chronic pain in cancer patients.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05877521.
PRIMARY OBJECTIVE:
I. To evaluate the feasibility and acceptability of three different MORE formats (16-hour, 8-hour, 2-hour) for cancer patients with chronic pain.
EXPLORATORY OBJECTIVES:
I. To evaluate the preliminary effect of MORE on pain-related interference and co-morbid symptoms.
II. To explore whether MORE demonstrates a dose response effect on pain-related interference (secondary outcome).
III. To explore whether MORE demonstrates a dose response effect on pain-related interference (secondary outcome).
IV. To test the feasibility and acceptability of the 16-hour MORE treatment among breast cancer survivors with AIA.
OUTLINE: Patients are randomized or assigned to 1 of 2 groups.
GROUP 1: Patients receive the MORE intervention over 2 hours once a week for 1, 4, or 8 weeks and practice mindfulness skills at home for 15 minutes per day in addition to their usual care.
GROUP 2: Patients receive their usual care for 8 weeks.
After completion of study intervention, patients are followed up at 1 month (week 12).
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorJun J. Mao
