Improving Quality of Life Based on Electronic Patient Reported Outcomes in Patients with CLL and MDS: The Mypal Study

Introduction: Palliative care is a critical component of care for patients with chronic hematological malignancies. Leveraging eHealth approaches can potentially facilitate the delivery of palliative care, leading to improved quality of life (QoL). Methods: The MyPal study (NCT04370457) is a randomized controlled clinical trial assessing an eHealth intervention on QoL of patients. The study was conducted according to the Declaration of Helsinki. The ethical aspects of the study, given the vulnerability of the patients, were addressed with diligence and approvals were obtained from the appropriate Research Ethics Committees. Patients who were receiving or had previously received treatment for CLL or MDS were randomly assigned (1:1) to access the MyPal platform versus standard of care. The MyPal platform included a smartphone application used to report QoL status (ePRO questionnaires) and symptoms. The primary endpoint was QoL at 12 months, assessed by the European Organization for Research and Treatment of Cancer (EORTC) quality of life QLQ-C30 General Questionnaire and the Euroqol 5-dimension (Euroqol EQ-5D-3L). Secondary endpoints included physical and emotional functioning, measured by the Integrated Palliative Care Outcome Scale (IPOS), satisfaction with care, measured by the EORTC Patient Satisfaction with Cancer Care questionnaire PATSAT-C33 (PATSAT-C33), and overall survival (OS). Additionally, the Edmonton Symptom Assessment System (ESAS), the Brief Pain Inventory (BPI), and the Emotion Thermometers (ET) QoL questionnaires were assessed only in the intervention group. Results: A total of 171 patients (97 and 74 in the control and intervention arms, respectively) who answered multiple questionnaires were included in the analysis. The intervention group reported a significant decrease in pain (β2=-0.48 (-0.77, -0.19), p<0.001) compared to the control group (β1=0.3 (0.09, 0.5), p=0.01) as measured by the EORTC QLQ-C30. Communication and pain as measured by IPOS reduced equally in both groups [β2=0 (-0.03, 0.02), p=0.82; β2=-0.01 (-0.02, 0), p=0.1, respectively]. Family involvement significantly increased over time only for the intervention group [β2=0.32 (0.01, 0.64), p=0.042]. 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 statistically significant improvement in all ESAS, BPI, and ET scales. The estimated absolute improvement between the first and last assessment was 1.68, 2.16, 0.96, 1.44, 1.68, and 0.96 points for pain, tiredness, nausea, drowsiness, appetite loss, and shortness of breath, respectively, and 0.96, 1.2 and 1.2 for depression, anxiety, and well-being, respectively. The estimated absolute improvement between the first and last assessment for both pain severity and the interference items of the BPI was 1.2 points. Finally, distress, anxiety, depression, anger, and need for help showed a statistically significant reduction over time and an absolute improvement between the first and last assessment of 1.68, 1.92, 1.2, 1.2, and 0.72 points, respectively. After 12 months, in the ITT, 6 (6.2%) patients died in the control arm and 5 (6.3%) in the intervention arm. Conclusion: The MyPal tools improved several aspects of QoL for patients with CLL and MDS while also promoting family involvement in palliative care.