Assessing an eHealth Intervention on Quality of Life in Patients with Chronic Lymphocytic Leukemia and Myelodysplastic Syndromes: The MyPal Randomized Controlled Trial

PURPOSEThe MyPal study (ClinicalTrials.gov identifier: NCT04370457) is a randomized controlled clinical trial assessing an eHealth intervention on the quality of life (QoL) of patients with chronic lymphocytic leukemia (CLL) and myelodysplastic syndromes (MDS).METHODSPatients who were receiving or had previously received treatment for CLL or MDS were randomly assigned (1:1) to access the MyPal digital health platform versus standard of care. The MyPal platform included a smartphone application used to report QoL status and symptoms via standardized questionnaires or spontaneous reporting. The primary end point was QoL at 12 months, assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 General Questionnaire and the EuroQol EQ-5D-3L. Secondary end points included physical and emotional functioning, measured by the Integrated Palliative Care Outcome Scale (IPOS) scale, satisfaction with care, measured by the EORTC PATSAT-C33, and overall survival (OS). Additionally, the Edmonton Symptom Assessment System (ESAS), Brief Pain Inventory (BPI), and Emotion Thermometers (ET) QoL questionnaires were assessed only in the intervention group.RESULTSA total of 171 patients (97 and 74 in the control and intervention arms, respectively) who answered multiple questionnaires were analyzed. The intervention group reported a significant decrease in pain (β2 = -0.48 [-0.77 to -0.19], P <.001) compared with the control group (β1 = 0.3 [0.09 to 0.5], P =.01). Communication and pain measured by IPOS reduced equally in both groups (β2 = 0 [-0.03 to 0.02], P =.82; β2 = -0.01 [-0.02 to 0], P =.1, respectively). Family involvement significantly increased over time only for the intervention group. The other items of EORTC QLQ-C30, EuroQol EQ-5D-3L, IPOS, and PATSAT-C33 remained unchanged in both groups. The intervention group displayed a significant improvement in all ESAS, BPI, and ET scales. OS was similar in both groups.CONCLUSIONThe MyPal intervention improved several QoL aspects and led to a statistically significant decrease in pain compared with the control group.