Psychological Mobile App for Patients With AML

Mass General Brigham

Status: Terminated

Conditions: AML; Acute Myeloid Leukemia

Treatments: Behavioral: DREAMLAND; Behavioral: CERENA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05501171

22-257

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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11 participants in 2 patient groups

DREAMLAND

Experimental group

Description:

Participants will be recruited from 5 sites and randomized in 1:1 fashion, stratified by study site, to DREAMLAND versus CERENA. * Participants will use DREAMLAND and during hospitalization for treatment of AML to learn how to cope most effectively with the diagnosis of AML using an iPad provided by the study team or participant's own iPad. * Questionnaires (in-person, over the computer or telephone, or by mail) at predetermined days per protocol days.

Treatment:

Behavioral: DREAMLAND

CERENA

Active Comparator group

Description:

Participants will be recruited from 5 sites and randomized in 1:1 fashion, stratified by study site, to DREAMLAND versus CERENA. * Participants will use the mobile app CERENA during hospitalization for treatment of AML to learn how to best care for themselves using an iPad provided by the study team or participant's own iPad. * Questionnaires (in-person, over the computer or telephone, or by mail) at predetermined days per protocol days.

Treatment:

Behavioral: CERENA