Actively Recruiting
Multi-Site Randomized Controlled Trial of a Novel Digital Application (DREAMLAND) to Improve Outcomes for Patients With Acute Myeloid Leukemia
Led by Massachusetts General Hospital · Updated on 2025-11-10
200
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effectiveness of a new self-administered digital app called DREAMLAND to improve long-term quality of life and psychological health for patients with acute myeloid leukemia (AML) undergoing intensive chemotherapy. AML patients face sudden, severe illness requiring urgent hospitalization and intensive treatment, which often leads to significant physical symptoms and psychological distress due to isolation and loss of independence during treatment. This study aims to compare DREAMLAND with another app, VITAL WELLNESS, to better support patients during this difficult period. DREAMLAND is a mobile psychological tool with four modules focused on psychotherapy, education, coping skills, and self-care, designed for use during a 4-6 week hospital stay for chemotherapy. Patients will be randomly assigned to either use DREAMLAND or VITAL WELLNESS, which offers physical health education on wellness, nutrition, exercise, and cancer prevention. Both apps are self-administered, with patients encouraged to complete one module each week during hospitalization. Participants will be closely monitored with patient-reported measures including quality of life, anxiety, depression, symptom burden, coping, and self-efficacy at various points up to 180 days after starting treatment. The study also examines the impact of the apps on psychological distress and symptom management. Enrollment is open to adults aged 18 to 120 with AML starting intensive chemotherapy, and outcomes will help determine the broader usefulness of DREAMLAND across different care settings.
CONDITIONS
Brief Title
Novel Digital Application for Patients With Acute Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hospitalized patients aged over 18 years with a diagnosis of AML
- Starting treatment with intensive chemotherapy (7+3) or similar regimens, or hypomethylating agents (HMA) with or without additional agents
- Ability to understand and speak English, as the digital apps are in English
- Patients newly diagnosed or with relapsed/refractory AML initiating intensive or HMA-based chemotherapy
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia
- Acute or unstable psychiatric or cognitive conditions that prevent informed consent or study compliance as determined by clinicians
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 to 6 weeks
Participants use a digital application (DREAMLAND or VITAL WELLNESS) during their hospitalization for intensive chemotherapy. They review one module each week, completing all modules by week 4 of their hospital stay.
Hospitalization period with daily in-hospital engagement
Duration - Up to 6 months
Participants are monitored after hospitalization to assess quality of life, psychological distress, symptom burden, and mental health outcomes up to 180 days.
Periodic follow-up visits and assessments up to 180 days
Trial Site Locations
Total: 3 locations
1
Massachusetts General Hospital (MGH)
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Duke University
Durham, North Carolina, United States, 27710
Not Yet Recruiting
3
Fred Hutchinson Cancer Research Center (FHCRC)
Seattle, Washington, United States, 98109
Not Yet Recruiting
Research Team
A
Areej El-Jawahri, MD
U
Upeka Samarakoon, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here