Ignite Creation Date:
2024-07-17 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06472128
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-09
Brief Title:
Novel Digital Application for Patients With Acute Leukemia
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Multi-Site Randomized Controlled Trial of a Novel Digital Application DREAMLAND to Improve Outcomes for Patients With Acute Myeloid Leukemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAVIGATE
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None