Recruiting

Digital Application

Sponsor:

Massachusetts General Hospital

Code:

NCT06472128

Conditions

Relapsed Adult Acute Myeloid Leukemia

Primary Refractory Acute Myeloid Leukemia

High Risk Acute Myeloid Leukemia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

DREAMLAND

VITAL WELLNESS

Study Details

Brief 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.

Conditions

Relapsed Adult Acute Myeloid Leukemia

Primary Refractory Acute Myeloid Leukemia

High Risk Acute Myeloid Leukemia

Study ID

NCT06472128

Start date

Oct 21, 2024

Status verified date

Nov, 2025

Completion date

Apr 30, 2030

Anticipated

Primary completion date

Apr 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: DREAMLAND

DREAMLAND is a self-administered, multicomponent mobile psychological intervention application for patients to be used during their hospitalization for intensive chemotherapy.

active comparator: VITAL WELLNESS

VITAL WELLNESS is a self-administered, multicomponent mobile application containing information on a range of physical health topics that guide patients through education about general wellness, nutrition, exercise, and cancer prevention.

Interventions

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.

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.

Primary outcome measure

  • Patient reported quality of life (QOL) at day 20 as measured by the Functional Assessment of Cancer Therapy-Leukemia scale [ Time Frame: Day +20 ]

Central Contacts and Locations

Central contacts

Areej El-Jawahri, MD

617-724-4000ael-jawahri@mgb.org

Upeka Samarakoon, PhD

ssamarakoon@mgh.harvard.edu

Locations

Massachusetts General Hospital (MGH)

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Areej El-Jawahri, MD

617-724-4000ael-jawahri@mgb.org

Upeka Samarakoon, PhD

ssamarakoon@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-11-10.