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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment DREAMLAND, VITAL WELLNESS for leukemia?

Digital health tools, like the ones used in the DREAMLAND, VITAL WELLNESS treatment, have shown promise in cancer care by improving communication between patients and doctors and helping manage symptoms. For example, a study found that a digital platform for monitoring patient-reported outcomes was easy to use and useful for enhancing communication in hematologic (blood-related) cancer care. ^{1 2 3 4 5}

Is the digital app for leukemia generally safe for humans?

The safety of treatments for leukemia, including digital apps, is often evaluated through clinical trials. These trials sometimes face challenges in accurately reporting adverse events (side effects), but efforts are made to improve this reporting. Additionally, drugs for blood cancers often undergo safety-related changes after they are approved, indicating that safety profiles can evolve over time. ^{6 7 8 9 10}

How is the DREAMLAND treatment for leukemia different from other treatments?

The DREAMLAND treatment is unique because it involves a digital app designed to help manage leukemia by providing educational and psychological support, symptom tracking, and real-time advice, which is not typically part of standard leukemia treatments. ^{2 11 12 13 14}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of mobile phone applications to support medication adherence and symptom management in oncology patients. [2019]

2. England 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Design of the functional requirements of a smartphone app for patients receiving oral antineoplastic agents: The e-OncoSalud® app. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Physicians' Perceptions of Clinical Utility of a Digital Health Tool for Electronic Patient-Reported Outcome Monitoring in Real-Life Hematology Practice. Evidence From the GIMEMA-ALLIANCE Platform. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of the electronic self-report Symptom Screening in Pediatrics Tool (SSPedi). [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Safety-Related Postmarketing Modifications of Drugs for Hematological Malignancies. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Accuracy of Adverse Event Ascertainment in Clinical Trials for Pediatric Acute Myeloid Leukemia. [2020]

8. England 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. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Adverse effects of drugs used to treat hematologic malignancies: surveillance efforts from the research on adverse drug events and reports project. [2013]

10. England 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. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Care at Your Fingertips: Codesign, Development, and Evaluation of the Oncology Hub App for Remote Symptom Management in Pediatric Oncology. [2023]

12. United States 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. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Pain monitoring app leads to less pain in children with cancer at home: Results of a randomized controlled trial. [2023]

14. England pubmed.ncbi.nlm.nih.gov

Developing "Care Assistant": A smartphone application to support caregivers of children with acute lymphoblastic leukaemia. [2017]