Clinical trial NCT05501171: Psychological Mobile App for Patients With AML
Official title: Randomized Controlled Trial of a Psychological Mobile Application (App) to Promote Coping for Patients With Acute Myeloid Leukemia (AML)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: AML
Acute Myeloid Leukemia
Keywords: AML
Acute Myeloid Leukemia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Blue Note Therapeutics
First posted: 2022-08-15
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Anxiety Symptoms
timeFrame: Day 20
Secondary outcomes:
measure: Anxiety Symptoms
timeFrame: Up to Day 90
measure: Depression Symptoms
timeFrame: Up to Day 90
measure: Quality of Life in Patients with Leukemia
timeFrame: Up to Day 90
measure: Symptom Burden
timeFrame: Up to Day 90
measure: Post-Traumatic Stress Disorder (PTSD) Symptoms
timeFrame: Up to Day 90
Other outcomes:
measure: Coping
timeFrame: Up to Day 90
measure: Self-efficacy
timeFrame: Up to Day 90
measure: Health care utilization
timeFrame: Up to 6 months
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Massachusetts General Hospital
name: Areej El-Jawahri, MD
role: PRINCIPAL_INVESTIGATOR
References: