High Risk Acute Myeloid Leukemia, Primary Refractory Acute Myeloid Leukemia, Relapsed Adult Acute Myeloid Leukemia
Conditions
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.
Interventions
BEHAVIORALDREAMLAND
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.
BEHAVIORALVITAL WELLNESS
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.
Sponsors
National Cancer Institute (NCI)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
* 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 Note: Patients newly diagnosed as well as those with relapsed/refractory AML initiating treatment with intensive or HMA-based chemotherapy will be eligible to participate.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Participant experience of application's usability as measured by the Systems Usability Scale | Day +60 | 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). |
| Participant perceived ability to used adaptive coping as measured by the Measure of Current Status Part A | Up to 180 days | 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 | Up to 180 days | 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). |
Countries
United States
Contacts
Primary ContactAreej El-Jawahri, MD
Backup ContactUpeka Samarakoon, PhD
Outcome results
None listed