Actively Recruiting

Phase Not Applicable
Age: 18Years - 120Years
All Genders
ID06472128

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

Age: 18Years - 120Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Inpatient Treatment

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

Follow-up

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

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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

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