Multi-Site Randomized Controlled Trial of a Novel Digital Application (DREAMLAND) to Improve Outcomes for Patients with Acute Myeloid Leukemia

PROJECT SUMMARY/ABSTRACT Overview: The goal of this study is to examine the efficacy of a novel digital application (app) for improving quality of life (QOL) and psychological outcomes in patients diagnosed with acute myeloid leukemia (AML). Background: Patients newly diagnosed with AML confront a sudden and life-threatening diagnosis, requiring an immediate disruption of their life and an urgent 4-6-week hospitalization to initiate intensive chemotherapy. During this hospitalization, they endure substantial physical symptoms due to the side-effects of chemotherapy, which negatively impact their QOL. Importantly, patients also experience immense psychological distress as they struggle with the abrupt onset of illness, uncertainty regarding their prognosis, physical and social isolation during hospitalization, and complete loss of independence. Despite the well-described psychological sequalae patients with AML experience, interventions to support them during this challenging hospitalization are limited. Moreover, limited availability of palliative care and mental health clinicians further hinders the scalability and dissemination of supportive care interventions to address the needs of all patients with AML. We developed a self-administered novel digital app (DREAMLAND) for patients with AML undergoing intensive chemotherapy. DREAMLAND includes four modules that focus on: 1) supportive psychotherapy to help patients adjust to the shock of diagnosis; 2) psychoeducation to manage illness expectations; 3) psychosocial skill-building to promote effective coping; and 4) self-care. We recently completed a pilot randomized trial demonstrating the feasibility of DREAMLAND and its promising efficacy for improving patient-reported QOL, anxiety and depression symptoms, as well as self-efficacy and symptom burden, compared to usual care. Based on these findings, DREAMLAND received an FDA Breakthrough Device Designation as a promising digital therapeutic for AML. Research Plan: We propose to conduct a multi-site randomized trial of DREAMLAND versus CERENA (a phys- ical health promotion control app) in 200 patients with AML undergoing intensive chemotherapy to test the effi- cacy of DREAMLAND for improving patient-reported outcomes in a large and more diverse patient population. We will also assess the impact of DREAMLAND on patients’ long-term QOL and psychological outcomes as well as explore mediators and moderators of the intervention effect on patient-reported QOL. Environment: This project will be conducted at Massachusetts General Hospital, Duke Cancer Center, and Fred Hutchinson Cancer Research Center. These sites have the supportive care research and leukemia experience, infrastructure, and processes to conduct this trial. The MGH research team has the expertise in developing and testing palliative, supportive care, and digital health interventions for patients with solid tumors and hematologic malignancies to ensure the successful implementation of this trial across all study sites. Relevance of Research: Data from this project will be used to obtain FDA approval for DREAMLAND as a digital therapeutic that can be prescribed to address the immense needs of patients with AML.