Psychological mobile app for patients with acute myeloid leukemia (AML): A randomized clinical trial.

12018 Background: Patients with AML experience substantial decline in their quality of life (QOL) and mood during their hospitalization for intensive chemotherapy. Yet, few interventions have been developed to enhance patient-reported outcomes during treatment. Methods: We conducted a randomized trial of a psychological mobile app (DREAMLAND) for patients with a new diagnosis of AML receiving intensive chemotherapy at Massachusetts General Hospital and Dana-Farber Cancer Institute. Patients were randomly assigned to DREAMLAND or usual care. DREAMLAND was tailored to the AML trajectory and included four required modules focused on 1) supportive psychotherapy to help patients deal with the initial shock of diagnosis; 2) psychoeducation to manage illness expectations; 3) psychosocial skill-building to promote effective coping; and 4) self-care. The primary endpoint was feasibility defined as at least 60% of eligible patients enrolling, and 60% of those enrolled completing at least 60% of the required modules. We assessed patient QOL (Functional-Assessment-of-Cancer-Therapy-Leukemia), psychological distress (Hospital-Anxiety-and-Depression-Scale [HADS] and Patient-Health-Questionnaire-9 [PHQ-9]), symptom burden (Edmonton-Symptom-Assessment-Scale), and self-efficacy (Cancer Self-Efficacy Scale) at baseline and day +20 post chemotherapy. We used ANCOVA to assess the effect of DREAMLAND on outcomes. Results: We enrolled 66.7% (60/90) of eligible patients and 62.1% completed ≥ 75% of intervention modules. At day +20 after intensive chemotherapy, patients randomized to DREAMLAND reported improved QOL (132.06 vs. 110.72, P = 0.001), lower anxiety (3.54 vs. 5.64, P = 0.010) and depression (HADS: 4.76 vs. 6.29, P = 0.121; PHQ-9: 4.62 vs. 8.35, P < 0.001) symptoms, and improved symptom burden (24.89 vs. 40.60, P = 0.007) and self-efficacy (151.84 vs. 135.43, P = 0.004) compared to the usual care group. Conclusions: A psychological mobile app for patients newly diagnosed with AML is feasible to integrate during hospitalization for intensive chemotherapy and may improve QOL, mood, symptom burden, and self-efficacy. Clinical trial information: NCT03372291.