NCT05501171

Psychological Mobile App for Patients With AML

Randomized Controlled Trial of a Psychological Mobile Application (App) to Promote Coping for Patients With Acute Myeloid Leukemia (AML)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• AML
• Acute Myeloid Leukemia

Interventions

Type	Name	Description
BEHAVIORAL	DREAMLAND	DREAMLAND is self-administered psychological app for patients with AML that includes four modules, focused on: 1. Supportive psychotherapy strategies to help patients deal with the initial shock of diagnosis, cope with the loss of independence and abrupt life disruptions, and provide validation and reassurance. 2. Psychoeducation to manage expectations and enhance preparedness for extended hospitalization and mobilize social support. 3. Psychosocial skill-building to promote effective coping strategies and facilitate acceptance while living with uncertainty. 4. Self-care to promote positive health behaviors and enhance patients´ sense of control especially as they transition from the hospital to outpatient care. Each module takes 20 minutes to complete. DREAMLAND also includes three optional models that also take 15 minutes to complete. Other names BNT200
BEHAVIORAL	CERENA	CERENA is a self-administered physical health app that includes 4 modules focused, focused on: 1. Education about general wellness. 2. Nutrition. 3. Exercise. 4. Cancer prevention. Each module takes 20 minutes to complete. CERENA also includes three optional modules that also take 15 minutes to complete.

Timeline

• Start date: 2022-10-15
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2022-08-15
• Last updated: 2023-08-02

Locations

3 sites across 1 country: United States