This trial studies how well yoga works in improving painful chemotherapy-induced peripheral neuropathy that has persisted for at least three months after the completion of chemotherapy treatment. Yoga intervention may help patients with chronic painful chemotherapy-induced peripheral neuropathy by improving symptoms that co-occur with pain (such as fatigue, anxiety) and strength and balance.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03824860.
PRIMARY OBJECTIVES:
I a. Determine the feasibility of yoga implementation by calculating participant recruitment, retention, and adherence rates in both groups of a randomized eight-week yoga trial.
I b. Explore intervention group participants’ perspectives of acceptability and satisfaction with the eight-week yoga intervention using semi-structured telephone interviews.
II. Characterize changes within and between study groups over the eight-week intervention period with regard to worst chemotherapy-induced peripheral neuropathy (CIPN) pain intensity, CIPN severity, physical function, sleep-related impairment, anxiety, depression, and fatigue (SPADE symptoms), and salivary cortisol.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive therapist guided, virtual or in-person, group yoga for up to 2 classes weekly over 45 minutes each for 8 weeks.
GROUP II: Patients receive usual care and symptom management strategies from clinicians for 8 weeks. After completion of data collection in the 8-week study time frame, patients are encouraged to attend the yoga classes.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorRobert J Knoerl
