Clinical trial NCT06472128: Novel Digital Application for Patients With Acute Leukemia
Official title: Multi-Site Randomized Controlled Trial of a Novel Digital Application (DREAMLAND) to Improve Outcomes for Patients With Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Relapsed Adult Acute Myeloid Leukemia
Primary Refractory Acute Myeloid Leukemia
High Risk Acute Myeloid Leukemia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-06-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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.

Primary outcomes:
measure: Patient reported quality of life (QOL) at day 20 as measured by the Functional Assessment of Cancer Therapy-Leukemia scale
timeFrame: Day +20
Secondary outcomes:
measure: Longitudinal patient reported quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Leukemia scale
timeFrame: Up to 180 days
measure: Participant anxiety symptoms assessed by the Hospital Anxiety and Depression Scale
timeFrame: Up to 180 days
measure: Participant depression symptoms as measured by the Hospital Anxiety Depression scale
timeFrame: Up to 180 days
measure: Participant depressive syndrome as measured by the patient Health Qiestionnaire-9 scale
timeFrame: Up to 180 days
measure: Participant symptom burden a assessed by the Edmonton Symptom Assessment scale
timeFrame: Day +20
measure: Participant post-traumatic stress symptoms as assessed by the Post-traumatic Stress Disorder Checklist Civilian Version.
timeFrame: Up to 180 days
Other outcomes:
measure: Participant perceived ability to used adaptive coping as measured by the Measure of Current Status Part A
timeFrame: Up to 180 days
measure: Participant self-efficacy level as measured by the Cancer Self-Efficacy scale
timeFrame: Up to 180 days
measure: Participant experience of application's usability as measured by the Systems Usability Scale
timeFrame: Day +60
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital (MGH)
state: Massachusetts
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center (FHCRC)
state: Washington
Study officials:
References: