Randomized Trial of Mindfulness during Radiation Therapy

Purpose/Objective(s)

Many patients receiving cancer treatment experience decreased quality of life (QoL). Evidence-based strategies are needed to mitigate this decline. Mindfulness meditation demonstrates promise in improving QoL in many patient populations but has not been studied in the radiation oncology setting. We aimed to evaluate the effectiveness of a mindfulness-based intervention (MBI) on QoL during and after radiotherapy (RT) for cancer treatment.

Materials/Methods

We conducted a randomized, phase 3 trial of weekly guided mindfulness meditation vs. standard of care (SOC) for patients undergoing RT. Patients and their caregivers were offered several 30-minute mindfulness sessions per week, as well as materials to practice mindfulness independently. Patients were meditation-naïve and scheduled for at least 3 weeks of curative-intent RT. Randomization was 1:1 using a permuted block design and stratified by baseline QoL (FACT-G > or < 90) and expected treatment intensity (high vs low). The primary endpoint was change in FACT-G score from baseline to end of RT. Secondary endpoints included change in LASA-6 score during RT, measure of relaxation during RT, and change in FACT-G, PROMIS 10, and LASA-6 scores in the year following RT. We estimated 190 patients were needed to provide 90% power to detect at least half a standard deviation change.

Results

We enrolled 53 patients over 9 months prior to a study pause in March 2020 due to COVID-19. After 6 months and implementation of COVID safety measures, the study reopened but only accrued 22 more patients in 10 months. Accrual closed at 75 patients. Sixty-eight patients completed the study – 31 in the MBI arm and 37 in SOC. Most patients in the MBI arm (58%) and the SOC arm (62%) underwent low intensity treatment (majority breast and prostate). Per recorded attendance, 42% of MBI patients were compliant with attending sessions at least once per week (average 0.8 sessions weekly). However, attendance may be under-recorded, as 94% of patients reported attending at least weekly. Of those receiving SOC, 43% reported use of independent wellness activities. There was no difference in QoL, as measured by change in FACT-G score, from baseline to end of RT, 3 months after, or 12 months after RT between arms. High intensity MBI patients trended toward greater improvement in FACT-G score between baseline and 12 months, and end of RT and 12 months (P = 0.097 and P = 0.095), than SOC patients. Per LASA-5 and PROMIS-10 QoL scores, the MBI group maintained QoL during RT, whereas the SOC group experienced decreased QoL (mean Δ0.0 vs -1.0, P = 0.019 per LASA-5; mean Δ0.1 vs -2.3, P = 0.042 per PROMIS-10). Patients in the MBI group reported greater improvement in relaxation from the start to end of RT (P = 0.002).

Conclusion

Participation in weekly 30-minute sessions of mindfulness meditation is a promising intervention for maintaining QoL and improving relaxation during RT. Further investigation into improving adherence is warranted.