Randomized Controlled Trial of a Psychological Mobile Application (App) to Promote Coping for Patients With Acute Myeloid Leukemia (AML)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- AML
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 11
- Locations
- 3
- Primary Endpoint
- Anxiety Symptoms
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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 one´s 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 patient's 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.
Investigators
El-Jawahri, Areej,M.D.
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •Hospitalized patients (aged 18 years or older) with a new diagnosis of AML
- •Receiving treatment with either a) intensive chemotherapy (7+3) or modification of this regimen on a clinical trial, or b) a similar intensive regimen requiring prolonged 3-6-week hospitalization
- •Ability to comprehend and speak English as the mobile apps are only available in English
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
Outcomes
Primary Outcomes
Anxiety Symptoms
Time Frame: Day 20
Compare anxiety symptoms between participants receiving DREAMLAND versus CERENA as measured by the Hospital Anxiety and Depression Scale (HADS)-anxiety subscale over 20 days. Higher scores on the HADS anxiety subscale (range 0-21) indicate greater anxiety symptoms.
Secondary Outcomes
- Symptom Burden(Up to Day 90)
- Anxiety Symptoms(Up to Day 90)
- Quality of Life in Patients with Leukemia(Up to Day 90)
- Depression Symptoms(Up to Day 90)
- Post-Traumatic Stress Disorder (PTSD) Symptoms(Up to Day 90)