Novel Digital Application for Patients With Acute Leukemia

Trial Title: Novel Digital Application for Patients With Acute Leukemia

NCT ID: NCT06472128

Condition: Relapsed Adult Acute Myeloid Leukemia
Primary Refractory Acute Myeloid Leukemia
High Risk Acute Myeloid Leukemia

Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: DREAMLAND
Description: 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.
Arm group label: DREAMLAND

Intervention type: Behavioral
Intervention name: VITAL WELLNESS
Description: 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.
Arm group label: VITAL WELLNESS

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.

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Hospitalized patients (age > 18 years) with a diagnosis of AML. - Initiating treatment with either intensive chemotherapy (7+3) or modification of this regimen on a clinical trial, or a similar intensive regimen that typically requires a prolonged 3-6-week hospitalization and/or recovery. - Ability to comprehend and speak English as the digital apps are only available in English 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.

Gender: All

Minimum age: 18 Years

Maximum age: 120 Years

Healthy volunteers: No

Locations:

Facility:
Name: Massachusetts General Hospital (MGH)

Address:
City: Boston
Zip: 02114
Country: United States

Contact:
Last name: Areej El-Jawahri, MD

Phone: 617-724-4000
Email: ael-jawahri@mgb.org

Contact backup:
Last name: Upeka Samarakoon, PhD
Email: ssamarakoon@mgh.harvard.edu

Facility:
Name: Duke University

Address:
City: Durham
Zip: 27710
Country: United States

Contact:
Last name: Thomas W LeBlanc, MD
Email: thomas.leblanc@duke.edu

Facility:
Name: Fred Hutchinson Cancer Research Center (FHCRC)

Address:
City: Seattle
Zip: 98109
Country: United States

Contact:
Last name: Mohamed Sorror, MD
Email: sorror@fredhutch.org

Start date: September 1, 2024

Completion date: April 30, 2030

Lead sponsor:
Agency: Massachusetts General Hospital
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: Massachusetts General Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06472128