Novel Digital Application for Patients With Acute Leukemia

NCT06472128 | Recruiting DMC

• 2 other identifiers: 24-025R01CA288550
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Longitudinal patient reported quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Leukemia scale

  Up to 180 days

• Participant anxiety symptoms assessed by the Hospital Anxiety and Depression Scale

  Up to 180 days

• Participant depression symptoms as measured by the Hospital Anxiety Depression scale

  Up to 180 days

• Participant depressive syndrome as measured by the patient Health Qiestionnaire-9 scale

  Up to 180 days

• Participant symptom burden a assessed by the Edmonton Symptom Assessment scale

  Day +20

Other Outcomes (3)

• Participant perceived ability to used adaptive coping as measured by the Measure of Current Status Part A

  Up to 180 days

• Participant self-efficacy level as measured by the Cancer Self-Efficacy scale

  Up to 180 days

• Participant experience of application's usability as measured by the Systems Usability Scale

  Day +60

Study Arms (2)

DREAMLAND

EXPERIMENTAL

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

Behavioral: DREAMLAND

VITAL WELLNESS

ACTIVE COMPARATOR

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

Interventions

DREAMLAND BEHAVIORAL

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.

DREAMLAND

VITAL WELLNESS BEHAVIORAL

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.

VITAL WELLNESS

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Massachusetts General Hospital (MGH)

Boston, Massachusetts, 02114, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

NOT YET RECRUITING

Fred Hutchinson Cancer Research Center (FHCRC)

Seattle, Washington, 98109, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Areej El-Jawahri, MD

CONTACT

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

Upeka Samarakoon, PhD

CONTACT

ssamarakoon@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: June 9, 2024
• First Posted: June 24, 2024
• Study Start: October 21, 2024
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2030
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (3)