Yoga-based supportive care for patients with head and neck cancer undergoing radiotherapy: Results of a three-arm randomized controlled trial.

292 Background: Radiotherapy (RT) to treat head and neck cancer (HNC) may result in debilitating toxicities and functional problems. Targeted yoga therapy delivered concurrently to RT may buffer against treatment-related sequelae. Given the high distress rates in spouses and interdependence of distress in couples, involving a spousal caregiver in the intervention may have additional benefits. Thus, we randomized patient-caregiver dyads to either a dyadic yoga (DY), patient yoga (PY) or usual care (UC) control arm. We hypothesized that both yoga arms are better than the UC arm regarding functional outcomes and healthcare utilization (i.e., feeding tube (FT) placements, emergency department (ED) and hospital admissions (HA) across the standard RT period. The comparison between the DY vs PY group was considered exploratory. Methods: HNC patients planned to receive ≥25 fractions of RT and their caregivers completed baseline assessments and were then randomized to the DY, PY or UC arm. Both yoga programs consisted of 15 sessions delivered parallel to the RT schedule. Sessions were either in person or via videoconference. Patients completed the self-report part of the PG-SGA on a weekly basis during the RT period (5-6 weeks). We extracted FT, ED and HA as healthcare utilization metrics from patients’ electronic medical records as binary variables (yes/no). Results: 100 patients (mean age: 60.3 yrs., 85% male, 79% NHW, 67% early stage, 54% chemo-RT) and caregivers (mean age: 54.9 yrs., 83% female, 78% NHW) were randomized (DY: n=34; PY: n=33, UC: n=33). Session attendance was high for both yoga arms (88% attended ≥ 10 session) with mean of 13.13 sessions in the DY and 13.30 sessions in the PY group. Intent to treat analyses using multi-level modeling controlling for patient age, sex, disease stage and treatment (RT vs CRT) revealed a significant effect between the DY and UC group for the physical function (F=5.27, p=.03) and the nutrition intake (F=4.97, p=.03) PG-SGA subscales favoring the DY group. The other comparisons (PY vs UC and DY vs PY) were not significant. None of the comparisons for the symptom and weight subscales were significant. Logistic regression analyses revealed a significant effect for FT placement so that both DY (p=.05) and PY (p=.02) groups had significantly fewer FTs than the UC group. The effect for ED visits was marginally significant and the effect for HA was not significant. Conclusions: Yoga therapy, particularly when delivered to patient-caregiver dyads, appears to be a beneficial behavioral supportive care strategy for HNC patients undergoing RT. We revealed significantly improved physical function and nutrition intake and fewer FTs relative to a UC comparison group. A larger comparative effectiveness trial is warranted. Clinical trial information: NCT04607590 .