Being Present-CML: A mindfulness-based intervention for patients with chronic myeloid leukemia taking tyrosine kinase inhibitors.

Abstract

353 Background: Tyrosine kinase inhibitors (TKIs) prolong the lives of patients with chronic phase chronic myeloid leukemia (CP-CML) but can cause side effects that negatively impact quality of life. Mindfulness-based interventions (MBIs) have improved symptoms in patients with solid tumors but have not been studied in patients with CP-CML. We sought to determine if a MBI is feasible and acceptable to patients with CP-CML and explored its preliminary efficacy. Methods: Being Present-CML is a prospective, single-arm clinical trial of an 8-week, online MBI developed for patients with GI cancers (Atreya, et al. PLoS One, 2018) and adapted to include qigong. Participants were recruited from a single academic institution. Eligibility included adult patients with CP-CML taking TKIs. Participants played audio-guided meditations at least 5 times per week on a secure website and participated in weekly, instructor-led meditation and qigong sessions on Zoom. Feasibility was assessed through measurement of recruitment and attrition. Adherence was determined by web capture. Acceptability was determined from surveys and qualitative interviews. Preliminary efficacy was evaluated by patient-reported outcome measures (PROMs) at baseline (week 0) and post-intervention (week 8). Descriptive statistics and two-tailed paired t-tests (p<0.05) were used to summarize the data. Interim results were presented previously; here we report the final results. Results: Between October 2020-September 2021, 121 eligible participants were approached to participate, and 46 patients (38%) consented. The median age was 49.5 years (range 23-75), 54.3% (n=25/46) were male, and 82.6% (n=38/46) were non-Hispanic White. At time of study start, 82.6% (n=38/36) were taking dasatinib, 84.7% (n=39/46) had a BCR-ABL1 PCR transcript ≤1%, and a median time since diagnosis of 70.5 months (range 1-234). Of 46 participants, 35 (76.1%) completed end of study procedures. The median number of audio meditations listened to per participant was 28.7 with an average of 4.1 per week. The median number of 8 weekly classes attended and/or recordings viewed per participant was 7 (range 0-8). At baseline, participants had an average NCCN Distress Thermometer score of 4.86 (range 0-8), which improved to 3.5 by week 8 (p=0.02). Nearly all participants would recommend the to others (median score of 9 on a 1-10 scale; 10=extremely likely). Conclusions: Patients with CP-CML taking TKIs found the MBI to be feasible and acceptable. PROM results suggest potential for distress reduction in this patient population. Clinical trial information: NCT04605211 .