NCT06472128

Novel Digital Application for Patients With Acute Leukemia

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

This research study is evaluating to examine the efficacy of a novel a self-administered digital application (DREAMLAND) for improving patients' long-term quality of life and psychological outcomes for patients with acute myeloid leukemia undergoing intensive chemotherapy.

Detailed description

Patients newly diagnosed with acute myeloid leukemia (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 quality of life. 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. The investigators 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. The investigators recently completed a pilot randomized trial demonstrating the feasibility of DREAMLAND and its promising efficacy for improving patient reported quality of life, 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. The purpose of this study is to conduct a multi-site randomized trial of DREAMLAND versus VITAL WELLNESS (a physical health promotion control app) in 200 patients with AML undergoing intensive chemotherapy to: a) demonstrate the efficacy of DREAMLAND versus VITAL WELLNESS for improving patient-reported quality of life, and psychological distress; b) assess the impact of DREAMLAND on patient-reported symptom burden, coping, and self-efficacy; c) explore mediators and moderators of the intervention effect on patient-reported quality of life; and d) establish the generalizability of DREAMLAND across care settings.

Conditions

• Relapsed Adult Acute Myeloid Leukemia
• Primary Refractory Acute Myeloid Leukemia
• High Risk Acute Myeloid Leukemia

Interventions

Type	Name	Description
BEHAVIORAL	DREAMLAND	Participants assigned to DREAMLAND will start using DREAMLAND during the first week of their hospitalization, with a suggested timeline of reviewing one module each week to complete the required modules by week 4 of their hospital stay.
BEHAVIORAL	VITAL WELLNESS	Participants assigned to VITAL WELLNESS will start using VITAL WELLNESS during the first week of their hospitalization, with a suggested timeline of reviewing one module each week to complete the required modules by week 4 of their hospital stay.

Timeline

• Start date: 2024-10-21
• Primary completion: 2029-04-30
• Completion: 2030-04-30
• First posted: 2024-06-24
• Last updated: 2025-11-10

Locations

3 sites across 1 country: United States