Novel Digital Application for Patients With Acute Leukemia
NCT Number: NCT06472128
Acronym: NAVIGATE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Relapsed Adult Acute Myeloid Leukemia|Primary Refractory Acute Myeloid Leukemia|High Risk Acute Myeloid Leukemia
Interventions: BEHAVIORAL: DREAMLAND|BEHAVIORAL: VITAL WELLNESS
Sponsor: Massachusetts General Hospital
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2030-04-30
Locations: Massachusetts General Hospital (MGH), Boston, Massachusetts, 02114, United States|Duke University, Durham, North Carolina, 27710, United States|Fred Hutchinson Cancer Research Center (FHCRC), Seattle, Washington, 98109, United States

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.

Primary Outcome Measures: 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 Outcome Measures: 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., Up to 180 days|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)., Up to 180 days|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)., Up to 180 days|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)., Up to 180 days|Participant symptom burden a assessed by the Edmonton Symptom Assessment scale, 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., Day +20|Participant post-traumatic stress symptoms as assessed by the Post-traumatic Stress Disorder Checklist Civilian Version., 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)., Up to 180 days
Other Outcome Measures: 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)., Up to 180 days|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)., Up to 180 days|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)., Day +60