Ignite Creation Date:
2024-05-06 @ 5:58 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05501171
Status:
TERMINATED
Last Update Posted:
2023-08-02
First Post:
2022-08-12
Brief Title:
Psychological Mobile App for Patients With AML
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Randomized Controlled Trial of a Psychological Mobile Application App to Promote Coping for Patients With Acute Myeloid Leukemia AML
Status:
TERMINATED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
the funding agency blue note therapeutics pulled out and did not provide funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study is evaluating whether a psychological mobile application app is efficacious in reducing anxiety and depression symptoms and improving quality of life for patients diagnosed with acute myeloid leukemia AML compared to a physical health promotion app
Detailed Description:
Patients with a new diagnosis of AML often 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 intensive chemotherapy which negatively impacts their quality of life Patients with AML also experience significant psychological distress as they struggle with the abrupt onset of illness uncertainty regarding their prognosis physical and social isolation during their hospitalization and complete loss of independence
From our prior studies we learnt that the use of DREAMLAND a psychological mobile app was feasible to integrate in the care of patients with AML receiving intensive chemotherapy and has promising efficacy for improving patients physical and psychological symptoms and their quality of life In this project the study doctors want to compare the effectiveness of DREAMLAND versus CERENA in improving the patient experience when diagnosed with AML CERENA is a mobile app that provides medical information about how to best take care of ones health Using this research the study doctors hope to find out the best way to help patients cope with the diagnosis and treatment for AML
The study will use questionnaires to measure patients quality of life physical symptoms mood and the participant sense of control over their situation Study questionnaires will be completed in the hospital or clinic The participants will also have the option of completing these questionnaires remotely through a secure web link or through a mailed paper copy
Blue Note Therapeutics Inc is supporting this research study by providing funding Blue Note Therapeutics is a digital health technology company that focuses on the health needs of patients with a cancer diagnosis
From our prior studies we learnt that the use of DREAMLAND a psychological mobile app was feasible to integrate in the care of patients with AML receiving intensive chemotherapy and has promising efficacy for improving patients physical and psychological symptoms and their quality of life In this project the study doctors want to compare the effectiveness of DREAMLAND versus CERENA in improving the patient experience when diagnosed with AML CERENA is a mobile app that provides medical information about how to best take care of ones health Using this research the study doctors hope to find out the best way to help patients cope with the diagnosis and treatment for AML
The study will use questionnaires to measure patients quality of life physical symptoms mood and the participant sense of control over their situation Study questionnaires will be completed in the hospital or clinic The participants will also have the option of completing these questionnaires remotely through a secure web link or through a mailed paper copy
Blue Note Therapeutics Inc is supporting this research study by providing funding Blue Note Therapeutics is a digital health technology company that focuses on the health needs of patients with a cancer diagnosis
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