Novel Digital Application for Patients With Acute Leukemia (NAVIGATE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Relapsed Adult Acute Myeloid Leukemia; High Risk Acute Myeloid Leukemia; Primary Refractory Acute Myeloid Leukemia
• Intervention / Treatment: Behavioral: DREAMLAND; Behavioral: VITAL WELLNESS

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Areej El-Jawahri, MD; Phone Number: 617-724-4000; Email: ael-jawahri@mgb.org
• Study Contact Backup: Name: Upeka Samarakoon, PhD; Email: ssamarakoon@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital (MGH)
      • Contact: Areej El-Jawahri, MD; Phone Number: 617-724-4000; Email: ael-jawahri@mgb.org
      • Contact: Upeka Samarakoon, PhD; Email: ssamarakoon@mgh.harvard.edu
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Not yet recruiting
      • Duke University
      • Contact: Thomas W LeBlanc, MD; Email: thomas.leblanc@duke.edu
  • Washington
    • Seattle, Washington, United States, 98109
      • Not yet recruiting
      • Fred Hutchinson Cancer Research Center (FHCRC)
      • Contact: Mohamed Sorror, MD; Email: sorror@fredhutch.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DREAMLAND; DREAMLAND is a self-administered, multicomponent mobile psychological intervention application for patients to be used during their hospitalization for intensive chemotherapy.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported quality of life (QOL) at day 20 as measured by the Functional Assessment of Cancer Therapy-Leukemia scale	To compare QOL at day +20 between those receiving DREAMLAND versus VITAL WELLNESS as measured by the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leukemia) at day 20. Higher scores on FACT-Leukemia (range 0-176) indicate a better QOL.	Day +20

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Longitudinal patient reported quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Leukemia scale	To compare QOL longitudinally between those receiving DREAMLAND versus VITAL WELLNESS as measured by the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leukemia). Higher scores on FACT-Leukemia (range 0-176) indicate a better QOL.	Up to 180 days
Participant anxiety symptoms assessed by the Hospital Anxiety and Depression Scale	To compare anxiety symptoms (both at day +20 and longitudinally) between those receiving DREAMLAND versus VITAL WELLNESS as measured by the Hospital Anxiety and Depression Scale (HADS) anxiety subscale. Lower scores on HADS anxiety subscale indicate less anxiety (score: 0-7-Normal, 8-10-Mild, 11-15-Moderate, 16-21-Severe).	Up to 180 days
Participant depression symptoms as measured by the Hospital Anxiety Depression scale	To compare depression symptoms both at day +20 and longitudinally between those receiving DREAMLAND versus VITAL WELLNESS as measured by the Hospital Anxiety and Depression Scale (HADS). Lower scores on HADS depression subscale indicate absence of depression (score: 0-7-Normal, 8-10-Mild, 11-15-Moderate, 16-21-Severe).	Up to 180 days
Participant depressive syndrome as measured by the patient Health Qiestionnaire-9 scale	To compare depressive syndrome symptoms both at day +20 and longitudinally between those receiving DREAMLAND versus VITAL WELLNESS as measured by the Patient Health Questionnaire-9 (PHQ-9). Lower PHQ-9 scores indicate absence or minimal depression (score: 0-4 -None-minimal, 5-9-Mild, 10-14-Moderate, 15-19-Moderately Severe, 20-27-Severe).	Up to 180 days
Participant symptom burden a assessed by the Edmonton Symptom Assessment scale	To compare symptom burden at day +20 between those receiving DREAMLAND versus VITAL WELLNESS as measured by the Edmonton Symptom Assessment Scale (ESAS-R). A higher ESAS-R score (total ranges from 0 to 60) indicates a higher physical symptom burden.	Day +20
Participant post-traumatic stress symptoms as assessed by the Post-traumatic Stress Disorder Checklist Civilian Version.	To compare post-traumatic stress symptoms (both at day +20 and longitudinally) between those receiving DREAMLAND versus VITAL WELLNESS as measured by the Post-traumatic Stress Disorder Checklist-Civilian Version. Scores above 44 indicates possible PTSD (scores range from 17 to 85).	Up to 180 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant perceived ability to used adaptive coping as measured by the Measure of Current Status Part A	To compare coping (both at day +20 and longitudinally) between those receiving DREAMLAND versus VITAL WELLNESS as measured by the Measure of Current Status Part A (MOCS-A). Higher MOCS-A scores indicate higher perceived ability to use adaptive coping techniques (scores range from 0-52).	Up to 180 days
Participant experience of application's usability as measured by the Systems Usability Scale	To explore participants´ usability of the apps at day +60 as measured by the System Usability Scale (SUS). Higher SUS scores indicate higher levels of usability (scored on a 0-100 scale).	Day +60
Participant self-efficacy level as measured by the Cancer Self-Efficacy scale	To compare self-efficacy (both at day +20 and longitudinally) between those receiving DREAMLAND versus VITAL WELLNESS as measured by the Cancer Self-Efficacy scale (CASE). Higher CASE scores indicate higher levels of self-efficacy (scores range from 12 to 48).	Up to 180 days

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2024
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2030

Study Registration Dates

• First Submitted: June 9, 2024
• First Submitted That Met QC Criteria: June 22, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): November 10, 2025
• Last Update Submitted That Met QC Criteria: November 6, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Leukemia; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute
• Other Study ID Numbers: 24-025; R01CA288550 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No