Dyadic versus individual delivery of a yoga program for family caregivers of glioma patients undergoing radiotherapy: Results of a 3-arm randomized controlled trial.

BACKGROUND: Despite their significant distress, supportive care interventions for caregivers of glioma patients are generally lacking. And, whether caregivers are more likely to benefit from interventions targeting patient-caregiver dyads or caregivers individually is unknown. This pilot randomized controlled trial compared the feasibility and preliminary efficacy of a dyadic yoga (DY) versus an individual caregiver yoga (CY) intervention as a supportive care strategy for family caregivers. METHODS: Patient-caregiver dyads were randomized to a DY, CY or usual care (UC) arm. DY and CY interventions were delivered over 15 sessions. Caregivers completed assessments of their depressive symptoms, quality of life (QOL), and caregiving reactions at baseline, 6 weeks, and 12 weeks, and a subset completed qualitative interviews at 12 weeks. RESULTS: With a consent rate of 63%, 67 dyads were randomized. Attendance in the DY was higher than in the CY group (session means, DY = 12.23, CY = 9.00; p = 0.06). Caregivers (79% female; 78% non-Hispanic White; mean age, 53 years) reported significantly more subjective benefit in the CY arm than in the DY arm (d = 2.1; p < .01), which was consistent with the qualitative assessment. There were medium effect sizes for improved mental QOL (d = 0.46) and financial burden (d = 0.53) in favor of the CY over the UC group. Caregivers in the CY group reported more caregiving esteem (d = 0.56) and less health decline (d = 0.60) than those in the DY group. CONCLUSION: Individual rather than dyadic delivery may be a superior supportive care approach for this vulnerable caregiver population. A larger, adequately powered efficacy trial is warranted.

A research protocol for a pilot, randomized controlled trial designed to examine the feasibility of a dyadic versus individual yoga program for family caregivers of glioma patients undergoing radiotherapy.

BACKGROUND: Although the diagnosis and treatment of a primary brain tumor present unique challenges to patients and their family caregivers, evidence-based supportive care interventions are generally lacking. The primary aim of this research protocol is to determine the feasibility of implementing a dyadic yoga (DY) versus a caregiver yoga (CY) intervention or a wait-list control (WLC) group using a randomized controlled trial design. METHODS: Seventy-five glioma patients undergoing radiotherapy and their family caregivers are randomized to the DY, CY, or a WLC group. Patient-caregiver dyads in the DY group and caregivers in the CY group receive 15 sessions (45 min each) over the course of patients' standard radiotherapy (6 weeks). Patients and caregivers in all groups complete baseline assessments of symptoms, quality of life (QOL), and health utilization outcomes prior to randomization. Follow-up assessments are performed 6 weeks and then again 3 months later. The primary outcome is feasibility (i.e., ≥ 50% of eligible dyads consent, ≥ 70% of enrolled dyads complete all assessments, and ≥ 50% of all practice sessions are attended). We will also perform primarily descriptive analyses of the self-reported outcomes (e.g., fatigue, overall QOL) and explore potential intervention moderators (e.g., performance status) to inform a larger future trial. CONCLUSION: This trial will provide important information regarding the feasibility of a dyadic versus a caregiver yoga intervention regarding symptom, QOL, and health utilization outcomes in glioma patients and their caregivers. TRIAL REGISTRATION: ClinicalTrials.gov NCT02481349.