Pilot randomized, controlled trial of a dyadic yoga program for glioma patients undergoing radiotherapy and their family caregivers

Abstract

Background: While the use of behavioral medicine in managing glioma patients' symptoms is not well studied, the high symptom burden in patients and their family caregivers is well established. We conducted a pilot randomized, controlled trial to examine the feasibility and preliminary efficacy of a dyadic yoga (DY) intervention as a supportive care strategy.

Methods: Glioma patients undergoing radiotherapy and their caregivers were randomized to a 12-session DY or waitlist control (WLC) group. Prior to radiotherapy and randomization, both groups completed measures of cancer-related symptoms (MD Anderson Symptom Inventory-Brain Tumor module), depressive symptoms (Center for Epidemiological Studies-Depression measure), fatigue (Brief Fatigue Inventory), and overall quality of life (QOL; Medical Outcomes Study 36-item short-form survey). Dyads were reassessed at the last day of radiotherapy.

Results: Twenty patients (mean age: 46 years, 50% female, 80% WHO grade IV and caregivers (mean age: 50 years, 70% female, 50% spouses) participated in the trial. A priori feasibility criteria were met regarding consent (70%), adherence (88%), and retention (95%) rates. Controlling for relevant covariates, change score analyses revealed clinically significant improvements for patients in the DY compared with the WLC group for overall cancer symptom severity (d = 0.96) and symptom interference (d = 0.74), depressive symptoms (d = 0.71), and mental QOL (d = 0.69). Caregivers in the DY group reported clinically significant improvements in depressive symptoms (d = 1.12), fatigue (d = 0.89), and mental QOL (d = 0.49) relative to those in the WLC group.

Conclusion: A DY intervention appears to be a feasible and beneficial symptom and QOL management strategy for glioma patients undergoing radiotherapy and their caregivers. An efficacy trial with a more stringent control group is warranted.

Clinical trial number: NCT02481349.

Keywords: controlled trial; glioma; patient-caregiver dyads; pilot randomized; quality of life; yoga.

Figures

Fig. 1

Consolidated Standards of Reporting Trials Flow Diagram. GI indicates gastrointestinal; Int, interference; WLC, waitlist control.

Fig. 2

Least Square Mean Difference Scores for MD Anderson Symptom Inventory-Brain Tumor Factors for the Yoga Group and Waitlist Control Group Controlling for Participants’ Sex and Age and Patients’ Performance Status and Tumor Grade. A, Patients. B, Caregivers. GI indicates gastrointestinal; Int, interference; WLC, waitlist control. Difference scores were calculated T2-T1 so that a negative score indicates a greater reduction in symptom severity and interference. The minimal clinically important difference for each factor is 1 point difference.