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.
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
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.
Parallel
DREAMLAND
BehavioralParticipants 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.
VITAL WELLNESS
BehavioralParticipants 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.
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.
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.
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).
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).
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).
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).
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).
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).
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Massachusetts General Hospital
Lead sponsor
National Cancer Institute (NCI)
Collaborator
