AMLNCT05501171
Psychological Mobile App for Patients With AML
A study testing DREAMLAND and CERENA in people with AML and Acute Myeloid Leukemia, run by Massachusetts General Hospital at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML, Acute Myeloid Leukemia
- What is being tested?
- DREAMLAND and CERENA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Oct 2022to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02115
Duke University
Durham, North Carolina, 27710
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: Randomized Controlled Trial of a Psychological Mobile Application (App) to Promote Coping for Patients With Acute Myeloid Leukemia (AML)
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.
Read the 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
- Being tested
- DREAMLAND, CERENA
- Keywords
- AML, Acute Myeloid Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DREAMLANDBehavioural
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
CERENABehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| DREAMLAND | Experimental | 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. Receives: Behavioral: DREAMLAND |
| CERENA | Active comparator | 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. Receives: Behavioral: CERENA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 20
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start15 Oct 2022
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Why it stopped: the funding agency (blue note therapeutics) pulled out and did not provide funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Note Therapeutics
- Responsible party
- Principal investigator, El-Jawahri, Areej,M.D., Massachusetts General Hospital
- Investigators
- Areej El-Jawahri, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501171
- Sponsor's protocol ID
- 22-257
- Status last verified
- Jul 2023
- First submitted
- 12 Aug 2022
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Psychological Mobile Application (App) to Promote Coping for Patients With Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT05501171
- Acronym / sponsor ID
- 22-257
- Conditions
- AML, Acute Myeloid Leukemia
- Keywords
- AML, Acute Myeloid Leukemia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the funding agency (blue note therapeutics) pulled out and did not provide funding
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Blue Note Therapeutics
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DREAMLAND | Experimental | Behavioral: DREAMLANDParticipants 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. |
| CERENA | Active comparator | Behavioral: CERENAParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DREAMLANDDREAMLAND 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 | Behavioural | DREAMLAND |
| CERENACERENA 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. | Behavioural | CERENA |
Primary outcome
Anxiety Symptoms
Time frame: Day 20
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.
5 secondary outcomes
Anxiety Symptoms
Time frame: Up to Day 90
Depression Symptoms
Time frame: Up to Day 90
Quality of Life in Patients with Leukemia
Time frame: Up to Day 90
Symptom Burden
Time frame: Up to Day 90
Post-Traumatic Stress Disorder (PTSD) Symptoms
Time frame: Up to Day 90
Results and safety
The study was stopped early (reason given: the funding agency (blue note therapeutics) pulled out and did not provide funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Areej El-Jawahri, MD principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DREAMLAND and CERENA in people with AML and Acute Myeloid Leukemia, run by Massachusetts General Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: the funding agency (blue note therapeutics) pulled out and did not provide funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Symptoms (time frame: Day 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.