Digital App for Leukemia

(NAVIGATE Trial)

Recruiting at 2 trial locations

Overseen By Upeka Samarakoon, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Acute promyelocytic leukemia, Unstable psychiatric conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital app called DREAMLAND to determine if it can improve the quality of life and mental health of people with acute myeloid leukemia (AML) undergoing intensive chemotherapy. Patients use DREAMLAND in the hospital to manage their mental well-being. The trial also compares DREAMLAND to another app, VITAL WELLNESS, which provides information on general health topics like nutrition and exercise. Individuals diagnosed with AML, hospitalized for intensive treatment, and who speak English might be suitable candidates. As an unphased trial, this study offers a unique opportunity to explore innovative digital tools that could enhance the hospital experience and mental health management.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this digital app is safe for leukemia patients?

Research has shown that DREAMLAND is a promising digital tool for patients with acute myeloid leukemia. The FDA has given it special recognition, highlighting its potential benefits. DREAMLAND, a mobile app, aids patients during their hospital stay for chemotherapy by providing therapy and educational content to help manage their diagnosis and treatment.

Early findings suggest that patients can use DREAMLAND during chemotherapy without major issues. Although specific safety data for DREAMLAND is limited, the FDA's recognition indicates confidence in its safety and potential effectiveness. As a digital tool, it is generally expected to be easier to use and tolerate compared to traditional drug treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DREAMLAND app because it offers a fresh approach to supporting leukemia patients during intensive chemotherapy. Unlike traditional treatments that focus on medication and physical care, DREAMLAND provides a psychological intervention that patients can self-administer through their mobile devices. This digital tool aims to improve mental well-being during hospital stays, which is an often-overlooked aspect of cancer treatment. By empowering patients with psychological support, DREAMLAND has the potential to enhance overall treatment experiences and outcomes.

What evidence suggests that this trial's digital apps could be effective for improving quality of life in leukemia patients?

Research has shown that DREAMLAND, one of the digital apps studied in this trial, might improve the quality of life and mental health for people with acute myeloid leukemia (AML) undergoing intensive chemotherapy. In one study, over 60% of patients used most of the app's features, and positive results appeared by day 20 after starting chemotherapy. The app includes engaging, game-like activities to help patients manage the stress and challenges of their treatment. Although more research is needed, early results suggest that DREAMLAND could be a useful tool for AML patients. Another app tested in this trial is VITAL WELLNESS, which provides information on physical health topics, guiding patients through education about general wellness, nutrition, exercise, and cancer prevention. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for hospitalized adults over 18 with acute myeloid leukemia (AML), starting intensive chemotherapy that requires a long hospital stay. Participants must understand and speak English as the digital apps are in English only. Those with acute promyelocytic leukemia or unstable psychiatric conditions can't join.

Inclusion Criteria

I am starting a strong chemotherapy that needs a long hospital stay.

Exclusion Criteria

I have been diagnosed with 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo intensive chemotherapy and use the DREAMLAND or VITAL WELLNESS app during a 4-6 week hospitalization

4-6 weeks

Inpatient hospitalization

Follow-up

Participants are monitored for quality of life, psychological distress, and other outcomes up to 180 days

Up to 180 days

What Are the Treatments Tested in This Trial?

Interventions

• DREAMLAND
• VITAL WELLNESS

Trial Overview The study tests a new self-administered digital app called DREAMLAND, aimed at improving life quality and mental health for AML patients during their intense chemotherapy treatment in the hospital.

How Is the Trial Designed?

Group I: DREAMLAND Experimental Treatment 1 Intervention

DREAMLAND is a self-administered, multicomponent mobile psychological intervention application for patients to be used during their hospitalization for intensive chemotherapy.

Group II: VITAL WELLNESS Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A scoping review identified 28 mobile apps designed for medication and symptom management in pediatric oncology patients, highlighting the potential for technology to support these patients.

The quality assessment of these apps revealed mean scores between 2.8 and 4.3, with most apps scoring low in user engagement, indicating a need for better design and functionality to enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of mobile phone applications to support medication adherence and symptom management in oncology patients. Jupp, JCY., Sultani, H., Cooper, CA., et al.[2019]

The QuestLeukemia mobile app was found to be an effective educational tool for pediatric patients preparing for hematopoietic cell transplantation (HCT), enhancing their disease knowledge and autonomy, as reported by both patients and parents.

Participants rated the app highly for usability and enjoyment, with average scores indicating it was easy to use (4.93), enjoyable (4.79), and comprehensive (4.71), suggesting it could positively impact the HCT experience for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability and Acceptability of the QuestLeukemia Mobile Application: A Pilot Study for An Educational and Psychological Intervention for Children with Chronic Illnesses. Meyer, R., Wang, K., Yearley, A., et al.[2022]

The 'Care Assistant' app was developed to support family caregivers of children with acute lymphoblastic leukaemia (ALL) by addressing key challenges such as limited access to medical information and difficulties in communication with healthcare providers.

The app includes eight modules designed to help caregivers track treatments, access financial and social assistance, and improve their knowledge about the disease, with plans for future studies to evaluate its usability and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing "Care Assistant": A smartphone application to support caregivers of children with acute lymphoblastic leukaemia. Wang, J., Yao, N., Wang, Y., et al.[2017]

The ExtractEHR automated package effectively identified and graded laboratory adverse events in a cohort of 1,077 children with acute myeloid leukaemia and acute lymphoblastic leukaemia, demonstrating its scalability and accuracy in capturing adverse event rates.

The study found that ExtractEHR reported significantly higher rates of laboratory adverse events compared to those manually reported in clinical trials, suggesting that automated systems can enhance the understanding of chemotherapy risks in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rates of laboratory adverse events by course in paediatric leukaemia ascertained with automated electronic health record extraction: a retrospective cohort study from the Children's Oncology Group. Miller, TP., Getz, KD., Li, Y., et al.[2023]

The Chemo Assist for Children (CAC) mHealth application was developed to help parents manage chemotherapy-related symptoms in children with acute lymphoblastic leukemia (ALL), based on a thorough needs assessment and usability testing.

Usability evaluations showed that the CAC application is valid and accessible, effectively enabling parents to identify and manage symptoms, thereby improving communication with healthcare providers and enhancing the independence of symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemo assist for children mobile health application to manage chemotherapy-related symptoms in acute leukemia in Indonesia: a user-centered design approach. Novrianda, D., Herini, ES., Haryanti, F., et al.[2023]

A review of 35 new drugs for hematological malignancies revealed that 80% had postmarketing safety-related label modifications, indicating that many drugs may have unrecognized side effects after approval.

Most of these drugs were approved based on limited evidence, with 77% not supported by randomized controlled trials, highlighting the need for caution among hematologists when prescribing these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety-Related Postmarketing Modifications of Drugs for Hematological Malignancies. Gafter-Gvili, A., Tibau, A., Raanani, P., et al.[2020]

Adverse event (AE) reporting in pediatric acute myeloid leukemia trials often underestimates the actual rates, with sensitivity for many AEs being less than 50%, indicating a need for improved reporting methods.

Using external electronic data sources, like Pediatric Health Information System (PHIS) billing and microbiology data, significantly enhances the accuracy of AE detection, particularly for specific toxicities such as viridans group streptococcal bacteremia, which showed high sensitivity and positive predictive value.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of Adverse Event Ascertainment in Clinical Trials for Pediatric Acute Myeloid Leukemia. Miller, TP., Li, Y., Kavcic, M., et al.[2020]

A new online toxicity registration strategy was developed for children and young adults treated under the Nordic/Baltic acute lymphoblastic leukaemia protocol, which streamlined the process and achieved a high compliance rate of 98.9% within 5 weeks.

This approach focuses on monitoring serious but rare adverse events, allowing for real-time toxicity profiles and early warnings for specific toxicities, which can enhance patient safety and inform treatment adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complying with the European Clinical Trials directive while surviving the administrative pressure - an alternative approach to toxicity registration in a cancer trial. Frandsen, TL., Heyman, M., Abrahamsson, J., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06472128

Novel Digital Application for Patients With Acute Leukemia This research study is evaluating to examine the efficacy of a novel a self-administered digital application (DREAMLAND) for improving patients' long-term ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36655338/

Psychological mobile app for patients with acute myeloid ... Results: We enrolled 60 of 90 eligible patients (66.7%), and 62.1% completed ≥75% of the intervention modules. At day 20 after chemotherapy, ...

3. maps.cancer.gov maps.cancer.gov/overview/DCCPSGrants/abstract.jsp?applId=10851083&term=CA288550

Division of Cancer Control & Population Sciences - Grant Details Multi-Site Randomized Controlled Trial of a Novel Digital Application (DREAMLAND) to Improve Outcomes for Patients with Acute Myeloid Leukemia. Fiscal Year ...

4. careacross.com careacross.com/clinical-trials/trial/NCT06472128

Novel Digital Application for Patients With Acute Leukemia 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 ...

5. massgeneral.org massgeneral.org/news/research-blog/dreamland-app-acute-myeloid-leukemia

DreAMLand App Seeks to Help Patients Cope with Trauma ... DreAMLand, an iPad-based app that uses an engaging game-like format to provide palliative care information and services for AML patients.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06472128

Novel Digital Application for Patients With Acute Leukemia 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 ...

7. trialx.com trialx.com/clinical-trials/listings/299486/novel-digital-application-for-patients-with-acute-leukemia/

Novel Digital Application for Patients With Acute Leukemia DREAMLAND includes four modules that focus on: 1) supportive psychotherapy to help patients adjust to the shock of diagnosis; 2) psychoeducation ...

8. apm.amegroups.org apm.amegroups.org/article/view/141144/html

Palliative care interventions and their early integration in the ... ... DREAMLAND, a psychological mobile app for ... Treatment pathways and challenges for patients ineligible for intensive chemotherapy.

9. reporter.nih.gov reporter.nih.gov/project-details/11417355

Prototype System for AML Digital Twins Multi-Site Randomized Controlled Trial of a Novel Digital Application (DREAMLAND) to Improve Outcomes for Patients with Acute Myeloid Leukemia. 282 ...