Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
11 participants
INTERVENTIONAL
2022-10-15
2023-02-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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DREAMLAND
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.
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
CERENA
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.
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* 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 acute or unstable psychiatric or cognitive conditions which the treating clinicians believes prohibits informed consent or compliance with study procedures
18 Years
ALL
No
Sponsors
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Blue Note Therapeutics
INDUSTRY
Massachusetts General Hospital
OTHER
Responsible Party
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El-Jawahri, Areej,M.D.
Principal Investigator
Principal Investigators
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Areej El-Jawahri, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Duke University
Durham, North Carolina, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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Other Identifiers
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22-257
Identifier Type: -
Identifier Source: org_study_id
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