Psychological Mobile App for Patients With AML

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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AML, Acute Myeloid Leukemia

Intervention / Treatment
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* Behavioral: DREAMLAND
* Behavioral: CERENA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DREAMLAND<br>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. | Behavioral: DREAMLAND<br>* DREAMLAND is self-administered psychological app for patients with AML that includes four modules, focused on: 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. Psychoeducation to manage expectations and enhance preparedness for extended hospitalization and mobilize social support. Psychosocial skill-building to promote effective coping strategies and facilitate acceptance while living with uncertainty. 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<br>|
| Active Comparator: CERENA<br>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. | Behavioral: CERENA<br>* CERENA is a self-administered physical health app that includes 4 modules focused, focused on: Education about general wellness. Nutrition. Exercise. Cancer prevention. Each module takes 20 minutes to complete. CERENA also includes three optional modules that also take 15 minutes to complete.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Symptoms | 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. | Day 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Symptoms | Compare anxiety symptoms between participants receiving DREAMLAND versus CERENA as measured by the Hospital Anxiety and Depression Scale (HADS)-anxiety subscale over 90 days. Higher scores on the HADS-anxiety subscale (range 0-21) indicate greater anxiety symptoms. | Up to Day 90 | 
| Depression Symptoms | Compare depression symptoms between participants receiving DREAMLAND versus CERENA as measured by the Hospital Anxiety and Depression Scale (HADS)-depression subscale and the Patient Health Questionnaire-9 (PHQ-9) over 90 days. Higher scores on the HADS-depression subscale (range 0-21) indicate greater depression symptoms. Higher scores on the PHQ-9 (range 0-27) indicate greater depression symptoms. | Up to Day 90 | 
| Quality of Life in Patients with Leukemia | Compare quality of life between participants receiving DREAMLAND versus CERENA as measured by the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leukemia) over 90 days. Higher scores on FACT-Leukemia (range 0-176) indicate better quality of life. | Up to Day 90 | 
| Symptom Burden | Compare symptom burden between participants receiving DREAMLAND versus CERENA as measured by the Edmonton Symptom Assessment Scale-Revised (ESAS-R) over 90 days. Higher scores on the ESAS-R (range 0-100) indicate worse symptom burden. | Up to Day 90 | 
| Post-Traumatic Stress Disorder (PTSD) Symptoms | Compare PTSD symptoms between participants receiving DREAMLAND versus CERENA as measured by the PTSD Checklist-Civilian Version over 90 days. Higher scores on the PTSD Checklist-Civilian Version (range 17-85) indicate greater PTSD symptoms. | Up to Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AML, Acute Myeloid Leukemia