Digital application for improving quality of life in acute leukemia patients
Multi-Site Randomized Controlled Trial of a Novel Digital Application (DREAMLAND) to Improve Outcomes for Patients With Acute Myeloid Leukemia
This study is testing a digital app designed to help newly diagnosed acute myeloid leukemia patients improve their quality of life and cope better during their chemotherapy treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Boston, Massachusetts and 2 other locations) |
| Trial ID | NCT06472128 on ClinicalTrials.gov |
What this trial studies
This research evaluates the efficacy of a self-administered digital application called DREAMLAND, designed to enhance the long-term quality of life and psychological outcomes for patients with acute myeloid leukemia (AML) undergoing intensive chemotherapy. The app includes four modules focusing on supportive psychotherapy, psychoeducation, psychosocial skill-building, and self-care to help patients cope with the challenges of their diagnosis and treatment. The study targets newly diagnosed AML patients who face significant physical and psychological distress during their hospitalization for chemotherapy. By providing a scalable digital intervention, the study aims to address the limited availability of supportive care for these patients.
Who should consider this trial
Good fit: Ideal candidates are hospitalized adults over 18 years old diagnosed with acute myeloid leukemia who are starting intensive chemotherapy.
Not a fit: Patients with acute promyelocytic leukemia or those with unstable psychiatric or cognitive conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this digital application could significantly improve the psychological well-being and quality of life for patients undergoing treatment for acute myeloid leukemia.
How similar studies have performed: Other studies have shown success with digital interventions for psychological support in cancer patients, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Hospitalized patients (age \> 18 years) with a diagnosis of AML. * Initiating treatment with either a) intensive chemotherapy (7+3) or modification of this regimen on a clinical trial, or a similar intensive regimen or b) hypomethylating agents (HMA) +/- additional agents or modification of this regimen on a clinical trial. * Ability to comprehend and speak English as the digital apps are only available in English Note: Patients newly diagnosed as well as those with relapsed/refractory AML initiating treatment with intensive or HMA-based chemotherapy will be eligible to participate. Exclusion Criteria: * Patients with a diagnosis of acute promyelocytic leukemia * Patients with acute or unstable psychiatric or cognitive conditions which the treating clinicians believes prohibits informed consent or compliance with study procedures.
Where this trial is running
Boston, Massachusetts and 2 other locations
- Massachusetts General Hospital (MGH) — Boston, Massachusetts, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Not_yet_recruiting)
- Fred Hutchinson Cancer Research Center (FHCRC) — Seattle, Washington, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Areej El-Jawahri, MD
- Email: ael-jawahri@mgb.org
- Phone: 617-724-4000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.