Viewing Study NCT03372291



Ignite Creation Date: 2024-05-06 @ 10:53 AM
Last Modification Date: 2024-10-26 @ 12:36 PM
Study NCT ID: NCT03372291
Status: COMPLETED
Last Update Posted: 2024-02-13
First Post: 2017-12-09

Brief Title: Psychological Intervention Mobile App for Patients With AML
Sponsor: Massachusetts General Hospital
Organization: Massachusetts General Hospital

Study Overview

Official Title: Randomized Study of a Psychological Intervention Mobile Application App to Promote Coping in Patients With Acute Myeloid Leukemia AML
Status: COMPLETED
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: None
Brief Summary: This research study is evaluating the impact of a psychological intervention mobile application app on the quality of life mood and symptoms of patients with acute myeloid leukemia AML
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 QOL 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 The study doctors want to know if the use of a mobile application app focused on helping patients cope with the diagnosis and treatment can reduce the distressing symptoms and improve the their quality of life and care

The main purpose of this research study is see if a mobile app is feasible to use for patients with new diagnosis of AML and is acceptable to them The study will also compare two types of care - standard leukemia care and standard leukemia care with the mobile app to see which is better for improving the experience of patients newly diagnosed with AML undergoing treatment

The purpose of this research study is to find out whether using the mobile app that is focused on educating patients about leukemia and how to cope with its treatment can improve the physical and psychological symptoms that patients experience during hospitalization for their leukemia care Using this research the study doctors hope to find out the best way to help patients cope with their diagnosis and treatment for acute myeloid leukemia

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 with assistance provided as needed The participants will also have the option of completing these questionnaires remotely through a secure web link or through a mailed paper copy

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