Relapsed Adult Acute Myeloid LeukemiaNAVIGATENCT06472128
Novel Digital Application for Patients With Acute Leukemia
A study testing DREAMLAND and VITAL WELLNESS in people with Relapsed Adult Acute Myeloid Leukemia and Primary Refractory Acute Myeloid Leukemia, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
This research study is evaluating to examine the efficacy of a novel a self-administered digital application (DREAMLAND) for improving patients' long-term quality of life and psychological outcomes for patients with acute myeloid leukemia undergoing intensive chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Relapsed Adult Acute Myeloid Leukemia, Primary Refractory Acute Myeloid Leukemia, High Risk Acute Myeloid Leukemia
- What is being tested?
- DREAMLAND and VITAL WELLNESS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Oct 2024to 30 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized patients (age > 18 years) with a diagnosis of AML.
- Initiating treatment with either a) intensive chemotherapy (7+3) or modification of this regimen on a clinical trial, or a similar intensive regimen or b) hypomethylating agents (HMA) +/- additional agents or modification of this regimen on a clinical trial.
- Ability to comprehend and speak English as the digital apps are only available in English
- Note: Patients newly diagnosed as well as those with relapsed/refractory AML initiating treatment with intensive or HMA-based chemotherapy will be eligible to participate.
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. Contact the study team or a site near you to ask about taking part.
Upeka Samarakoon, PhD contact
United States3 sites, 3 recruiting
- Recruiting
Massachusetts General Hospital (MGH)
Boston, Massachusetts, 02114
Areej El-Jawahri, MD, 617-724-4000, ael-jawahri@mgb.org
Upeka Samarakoon, PhD, ssamarakoon@mgh.harvard.edu
- Not yet recruiting
Duke University
Durham, North Carolina, 27710
Thomas W LeBlanc, MD, thomas.leblanc@duke.edu
- Not yet recruiting
Fred Hutchinson Cancer Research Center (FHCRC)
Seattle, Washington, 98109
Mohamed Sorror, MD, sorror@fredhutch.org
About this study
Official title: Multi-Site Randomized Controlled Trial of a Novel Digital Application (DREAMLAND) to Improve Outcomes for Patients With Acute Myeloid Leukemia
This research study is evaluating to examine the efficacy of a novel a self-administered digital application (DREAMLAND) for improving patients' long-term quality of life and psychological outcomes for patients with acute myeloid leukemia undergoing intensive chemotherapy.
Read the detailed description
Patients newly diagnosed with acute myeloid leukemia (AML) 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 chemotherapy, which negatively impact their quality of life. Importantly, patients also experience immense psychological distress as they struggle with the abrupt onset of illness, uncertainty regarding their prognosis, physical and social isolation during hospitalization, and complete loss of independence.
Despite the well-described psychological sequalae patients with AML experience, interventions to support them during this challenging hospitalization are limited. Moreover, limited availability of palliative care and mental health clinicians further hinders the scalability and dissemination of supportive care interventions to address the needs of all patients with AML. The investigators developed a self-administered novel digital app (DREAMLAND) for patients with AML undergoing intensive chemotherapy. DREAMLAND includes four modules that focus on: 1) supportive psychotherapy to help patients adjust to the shock of diagnosis; 2) psychoeducation to manage illness expectations; 3) psychosocial skill-building to promote effective coping; and 4) self-care. The investigators recently completed a pilot randomized trial demonstrating the feasibility of DREAMLAND and its promising efficacy for improving patient reported quality of life, anxiety, and depression symptoms, as well as self-efficacy and symptom burden, compared to usual care. Based on these findings, DREAMLAND received an FDA Breakthrough Device Designation as a promising digital therapeutic for AML.
The purpose of this study is to conduct a multi-site randomized trial of DREAMLAND versus VITAL WELLNESS (a physical health promotion control app) in 200 patients with AML undergoing intensive chemotherapy to: a) demonstrate the efficacy of DREAMLAND versus VITAL WELLNESS for improving patient-reported quality of life, and psychological distress; b) assess the impact of DREAMLAND on patient-reported symptom burden, coping, and self-efficacy; c) explore mediators and moderators of the intervention effect on patient-reported quality of life; and d) establish the generalizability of DREAMLAND across care settings.
- Conditions
- Relapsed Adult Acute Myeloid Leukemia, Primary Refractory Acute Myeloid Leukemia, High Risk Acute Myeloid Leukemia
- Being tested
- DREAMLAND, VITAL WELLNESS
- 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
Participants assigned to DREAMLAND will start using DREAMLAND during the first week of their hospitalization, with a suggested timeline of reviewing one module each week to complete the required modules by week 4 of their hospital stay.
VITAL WELLNESSBehavioural
Participants assigned to VITAL WELLNESS will start using VITAL WELLNESS during the first week of their hospitalization, with a suggested timeline of reviewing one module each week to complete the required modules by week 4 of their hospital stay.
| Study group | Role | What they receive |
|---|---|---|
| DREAMLAND | Experimental | DREAMLAND is a self-administered, multicomponent mobile psychological intervention application for patients to be used during their hospitalization for intensive chemotherapy. Receives: Behavioral: DREAMLAND |
| VITAL WELLNESS | Active comparator | VITAL WELLNESS is a self-administered, multicomponent mobile application containing information on a range of physical health topics that guide patients through education about general wellness, nutrition, exercise, and cancer prevention. Receives: Behavioral: VITAL WELLNESS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported quality of life (QOL) at day 20 as measured by the Functional Assessment of Cancer Therapy-Leukemia scale
To compare QOL at day +20 between those receiving DREAMLAND versus VITAL WELLNESS as measured by the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leukemia) at day 20.
Higher scores on FACT-Leukemia (range 0-176) indicate a better QOL.
Measured: Day +20
Secondary outcomes (6)
Longitudinal patient reported quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Leukemia scale
To compare QOL longitudinally between those receiving DREAMLAND versus VITAL WELLNESS as measured by the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leukemia).
Higher scores on FACT-Leukemia (range 0-176) indicate a better QOL.
Measured: Up to 180 days
Participant anxiety symptoms assessed by the Hospital Anxiety and Depression Scale
To compare anxiety symptoms (both at day +20 and longitudinally) between those receiving DREAMLAND versus VITAL WELLNESS as measured by the Hospital Anxiety and Depression Scale (HADS) anxiety subscale.
Lower scores on HADS anxiety subscale indicate less anxiety (score: 0-7-Normal, 8-10-Mild, 11-15-Moderate, 16-21-Severe).
Measured: Up to 180 days
Participant depression symptoms as measured by the Hospital Anxiety Depression scale
To compare depression symptoms both at day +20 and longitudinally between those receiving DREAMLAND versus VITAL WELLNESS as measured by the Hospital Anxiety and Depression Scale (HADS).
Lower scores on HADS depression subscale indicate absence of depression (score: 0-7-Normal, 8-10-Mild, 11-15-Moderate, 16-21-Severe).
Measured: Up to 180 days
Participant depressive syndrome as measured by the patient Health Qiestionnaire-9 scale
To compare depressive syndrome symptoms both at day +20 and longitudinally between those receiving DREAMLAND versus VITAL WELLNESS as measured by the Patient Health Questionnaire-9 (PHQ-9).
Lower PHQ-9 scores indicate absence or minimal depression (score: 0-4 -None-minimal, 5-9-Mild, 10-14-Moderate, 15-19-Moderately Severe, 20-27-Severe).
Measured: Up to 180 days
Participant symptom burden a assessed by the Edmonton Symptom Assessment scale
To compare symptom burden at day +20 between those receiving DREAMLAND versus VITAL WELLNESS as measured by the Edmonton Symptom Assessment Scale (ESAS-R).
A higher ESAS-R score (total ranges from 0 to 60) indicates a higher physical symptom burden.
Measured: Day +20
Participant post-traumatic stress symptoms as assessed by the Post-traumatic Stress Disorder Checklist Civilian Version.
To compare post-traumatic stress symptoms (both at day +20 and longitudinally) between those receiving DREAMLAND versus VITAL WELLNESS as measured by the Post-traumatic Stress Disorder Checklist-Civilian Version.
Scores above 44 indicates possible PTSD (scores range from 17 to 85).
Measured: Up to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start21 Oct 2024
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Adult Acute Myeloid LeukemiaStudies 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
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, El-Jawahri, Areej,M.D., Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472128
- Sponsor's protocol ID
- 24-025
- Other IDs
- R01CA288550
- Acronym
- NAVIGATE
- Status last verified
- Nov 2025
- First submitted
- 9 Jun 2024
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Site Randomized Controlled Trial of a Novel Digital Application (DREAMLAND) to Improve Outcomes for Patients With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT06472128
- Acronym / sponsor ID
- NAVIGATE / 24-025
- Conditions
- Relapsed Adult Acute Myeloid Leukemia, Primary Refractory Acute Myeloid Leukemia, High Risk Acute Myeloid Leukemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 24 Jun 2024 (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 to examine the efficacy of a novel a self-administered digital application (DREAMLAND) for improving patients' long-term quality of life and psychological outcomes for patients with acute myeloid leukemia undergoing intensive chemotherapy.
Detailed description
Patients newly diagnosed with acute myeloid leukemia (AML) 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 chemotherapy, which negatively impact their quality of life. Importantly, patients also experience immense psychological distress as they struggle with the abrupt onset of illness, uncertainty regarding their prognosis, physical and social isolation during hospitalization, and complete loss of independence.
Despite the well-described psychological sequalae patients with AML experience, interventions to support them during this challenging hospitalization are limited. Moreover, limited availability of palliative care and mental health clinicians further hinders the scalability and dissemination of supportive care interventions to address the needs of all patients with AML. The investigators developed a self-administered novel digital app (DREAMLAND) for patients with AML undergoing intensive chemotherapy. DREAMLAND includes four modules that focus on: 1) supportive psychotherapy to help patients adjust to the shock of diagnosis; 2) psychoeducation to manage illness expectations; 3) psychosocial skill-building to promote effective coping; and 4) self-care. The investigators recently completed a pilot randomized trial demonstrating the feasibility of DREAMLAND and its promising efficacy for improving patient reported quality of life, anxiety, and depression symptoms, as well as self-efficacy and symptom burden, compared to usual care. Based on these findings, DREAMLAND received an FDA Breakthrough Device Designation as a promising digital therapeutic for AML.
The purpose of this study is to conduct a multi-site randomized trial of DREAMLAND versus VITAL WELLNESS (a physical health promotion control app) in 200 patients with AML undergoing intensive chemotherapy to: a) demonstrate the efficacy of DREAMLAND versus VITAL WELLNESS for improving patient-reported quality of life, and psychological distress; b) assess the impact of DREAMLAND on patient-reported symptom burden, coping, and self-efficacy; c) explore mediators and moderators of the intervention effect on patient-reported quality of life; and d) establish the generalizability of DREAMLAND across care settings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DREAMLAND | Experimental | Behavioral: DREAMLANDDREAMLAND is a self-administered, multicomponent mobile psychological intervention application for patients to be used during their hospitalization for intensive chemotherapy. |
| VITAL WELLNESS | Active comparator | Behavioral: VITAL WELLNESSVITAL WELLNESS is a self-administered, multicomponent mobile application containing information on a range of physical health topics that guide patients through education about general wellness, nutrition, exercise, and cancer prevention. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hospitalized patients (age > 18 years) with a diagnosis of AML.
- Initiating treatment with either a) intensive chemotherapy (7+3) or modification of this regimen on a clinical trial, or a similar intensive regimen or b) hypomethylating agents (HMA) +/- additional agents or modification of this regimen on a clinical trial.
- Ability to comprehend and speak English as the digital apps are only available in English
- Note: Patients newly diagnosed as well as those with relapsed/refractory AML initiating treatment with intensive or HMA-based chemotherapy will be eligible to participate.
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 |
|---|---|---|
| DREAMLANDParticipants assigned to DREAMLAND will start using DREAMLAND during the first week of their hospitalization, with a suggested timeline of reviewing one module each week to complete the required modules by week 4 of their hospital stay. | Behavioural | DREAMLAND |
| VITAL WELLNESSParticipants assigned to VITAL WELLNESS will start using VITAL WELLNESS during the first week of their hospitalization, with a suggested timeline of reviewing one module each week to complete the required modules by week 4 of their hospital stay. | Behavioural | VITAL WELLNESS |
Primary outcome
Patient reported quality of life (QOL) at day 20 as measured by the Functional Assessment of Cancer Therapy-Leukemia scale
Time frame: Day +20
To compare QOL at day +20 between those receiving DREAMLAND versus VITAL WELLNESS as measured by the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leukemia) at day 20. Higher scores on FACT-Leukemia (range 0-176) indicate a better QOL.
6 secondary outcomes
Longitudinal patient reported quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Leukemia scale
Time frame: Up to 180 days
Participant anxiety symptoms assessed by the Hospital Anxiety and Depression Scale
Time frame: Up to 180 days
Participant depression symptoms as measured by the Hospital Anxiety Depression scale
Time frame: Up to 180 days
Participant depressive syndrome as measured by the patient Health Qiestionnaire-9 scale
Time frame: Up to 180 days
Participant symptom burden a assessed by the Edmonton Symptom Assessment scale
Time frame: Day +20
Participant post-traumatic stress symptoms as assessed by the Post-traumatic Stress Disorder Checklist Civilian Version.
Time frame: Up to 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- 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.
Upeka Samarakoon, PhD contact
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 VITAL WELLNESS in people with Relapsed Adult Acute Myeloid Leukemia and Primary Refractory 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 4 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: looking for participants now, as of the sponsor's last update on 10 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Areej El-Jawahri, MD (617-724-4000, ael-jawahri@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported quality of life (QOL) at day 20 as measured by the Functional Assessment of Cancer Therapy-Leukemia scale (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 10 Nov 2025.