Novel Digital Application for Patients With Acute Leukemia
- Conditions
- Relapsed Adult Acute Myeloid LeukemiaPrimary Refractory Acute Myeloid LeukemiaHigh Risk Acute Myeloid Leukemia
- Interventions
- Behavioral: DREAMLANDBehavioral: VITAL WELLNESS
- Registration Number
- NCT06472128
- Lead Sponsor
- Massachusetts General Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DREAMLAND DREAMLAND DREAMLAND is a self-administered, multicomponent mobile psychological intervention application for patients to be used during their hospitalization for intensive chemotherapy. VITAL WELLNESS 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.
- Primary Outcome Measures
Name Time Method Patient reported quality of life (QOL) at day 20 as measured by the Functional Assessment of Cancer Therapy-Leukemia scale Day +20 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.
- Secondary Outcome Measures
Name Time Method Participant depression symptoms as measured by the Hospital Anxiety Depression scale Up to 180 days 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).Participant post-traumatic stress symptoms as assessed by the Post-traumatic Stress Disorder Checklist Civilian Version. Up to 180 days 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).Longitudinal patient reported quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Leukemia scale Up to 180 days 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.Participant depressive syndrome as measured by the patient Health Qiestionnaire-9 scale Up to 180 days 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).Participant anxiety symptoms assessed by the Hospital Anxiety and Depression Scale Up to 180 days 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).Participant symptom burden a assessed by the Edmonton Symptom Assessment scale Day +20 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.
Trial Locations
- Locations (6)
Massachusetts General Hospital (MGH)
🇺🇸Boston, Massachusetts, United States
Fred Hutchinson Cancer Research Center (FHCRC)
🇺🇸Seattle, Washington, United States
Duke University
🇺🇸Durham, North Carolina, United States
Massachusetts General Hospital (MGH)
🇺🇸Boston, Massachusetts, United States
Duke University
🇺🇸Durham, North Carolina, United States
Fred Hutchinson Cancer Research Center (FHCRC)
🇺🇸Seattle, Washington, United States