Educational Intervention for Bone Marrow Transplant Complications

(DREAM-BMT Trial)

Overseen By Jake New, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Scripps Translational Science Institute

Disqualifiers: Failed prior alloHSCT

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

Compensation: Varies

Number of Visits: 1

Duration: 100 days

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an educational app can improve sleep and physical activity in individuals undergoing a specific type of bone marrow transplant called alloHSCT. Participants will either use the app or receive usual care to determine which approach is more effective. The trial is open to adults planning to undergo alloHSCT who can access the app on a digital device. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance recovery experiences for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this educational intervention is safe for patients undergoing alloHSCT?

Previous studies have shown that educational programs delivered through apps are generally well-received and safe. Research indicates that while people used these apps moderately, no major safety issues emerged. In fact, frequent app users experienced health improvements, such as better meal completion.

These findings suggest that app-based educational programs are not only safe but can also enhance health. As this program is educational, it carries a low risk of side effects, ensuring safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the app-based educational intervention for bone marrow transplant patients because it offers a unique, evidence-based approach to optimizing sleep and physical activity. Unlike standard care, which generally doesn't include focused educational support for these lifestyle factors, this app provides tailored guidance to help patients manage common post-transplant complications. By potentially improving sleep and activity levels, this intervention could enhance overall recovery and quality of life for patients undergoing allogeneic Hematopoietic Stem Cell Transplantation.

What evidence suggests that this app-based educational intervention is effective for improving sleep in patients undergoing alloHSCT?

Research has shown that an app-based educational program, which participants in this trial may receive, can improve health for patients undergoing allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT). Using the app, which provides advice on sleep and physical activity, has been linked to better health outcomes, such as increased meal consumption. This suggests that the app may help patients manage their recovery more effectively. The app aims to improve sleep, which is crucial for healing and overall well-being during and after the transplant. Early results are promising, highlighting the potential of digital tools to support patient health during this challenging treatment phase. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are about to receive a bone marrow transplant from any source and can use an app on their digital device. They must be able to read study materials and give informed consent through the app.

Inclusion Criteria

I have a smartphone or tablet that can download apps.

I can read and understand study documents and consent forms on an app.

I am planning to have a stem cell transplant from a donor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-treatment

Baseline collection of patient samples and initial assessments in the patient's home environment

2 weeks

Home visits

Treatment

Participants receive either educational intervention or standard of care therapy during alloHSCT

100 days

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including sleep and activity measurements

100 days

Continuous monitoring

What Are the Treatments Tested in This Trial?

Interventions

• App-based Educational Intervention

Trial Overview The study is testing whether an educational app can help manage sleep better than the usual care given to patients undergoing bone marrow transplants. It's in early stages (phase I/II) with plans to include around 60 participants.

How Is the Trial Designed?

Group I: App-based Educational Intervention Experimental Treatment 1 Intervention

The intervention is a pioneering, evidence-based educational program designed to optimize sleep and physical activity outcomes in patients undergoing allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT).

Group II: Standard of Care Monitoring Active Control 1 Intervention

Usual care will be undergoing alloHSCT without any additional sleep-related educational interventions.

Who Is Running the Clinical Trial?

Scripps Translational Science Institute

Lead Sponsor

Trials

53

Recruited

572,000+

Published Research Related to This Trial

The TRU-BMT mHealth app was developed to help hematopoietic stem cell transplantation (HCT) patients monitor their health daily, aiming to improve symptom tracking and early detection of complications, with a pilot study involving 30 patients over 180 days.

Adherence to the app was around 30% daily and 44% weekly, and higher adherence correlated with better health outcomes, such as increased meal completion and shorter hospital stays, indicating the app's potential to enhance patient management during HCT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Feasibility of a Novel mHealth App in Hematopoietic Stem Cell Transplant Patients. Racioppi, A., Dalton, T., Ramalingam, S., et al.[2023]

The MY-Medula mHealth platform was successfully implemented in a pilot study with 28 allogeneic stem cell transplantation (allo-SCT) recipients, showing high usability with a median of 143 app visits per patient over 2 months.

Patients and healthcare professionals reported high satisfaction rates (95% and 100%, respectively) with the integrated care model, indicating that mHealth tools can enhance follow-up care for allo-SCT recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a New Model of Care for Allogeneic Stem Cell Transplantation Recipients Facilitated by eHealth: The MY-Medula Pilot Study. Redondo, S., De Dios, A., Gomis-Pastor, M., 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 INTERACCT mobile app significantly improved the quality of self-reported medical data in adolescent HSCT patients compared to traditional paper diaries, with a score of 4.14 versus 3.77 (P=.02).

Adolescents, especially those with treatment-related complications, used the app longer and reported higher satisfaction, indicating that the app is a promising tool for enhancing patient compliance and communication in long-term cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web-Based Mobile App (INTERACCT App) for Adolescents Undergoing Cancer and Hematopoietic Stem Cell Transplantation Aftercare to Improve the Quality of Medical Information for Clinicians: Observational Study. Lawitschka, A., Buehrer, S., Bauer, D., et al.[2021]

Medication non-adherence in children, especially those receiving hematopoietic stem cell transplants, is a significant issue, with rates between 50% and 80%, which can lead to life-threatening complications.

The BMT4me© mobile health app is designed to improve medication adherence by sending reminders and tracking medication-taking behaviors in real-time, and its efficacy will be evaluated in a randomized controlled trial comparing it to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving medication adherence monitoring and clinical outcomes through mHealth: A randomized controlled trial protocol in pediatric stem cell transplant. Ralph, JE., Sezgin, E., Stanek, CJ., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-gvhd-9-2024-8e054

Educational Intervention for Bone Marrow Transplant ... Adherence to the app was around 30% daily and 44% weekly, and higher adherence correlated with better health outcomes, such as increased meal completion and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11816169/

The Applications of Machine Learning in the Management ... This review examines the applications of ML in HSCT, focusing on donor selection, conditioning regimen, and prediction of post-transplant outcomes.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666636720300257

Assessing the Feasibility of a Novel mHealth App in ... Our team collaborated with Sicklesoft, Inc., to develop an mHealth app specifically for HCT patients to allow for daily evaluation of patient health.

4. astctjournal.org astctjournal.org/article/S1083-8791(15)00378-X/fulltext

Implementation of an Advanced Practice Provider Service ... One hundred–day ASCT outcomes were not different between patients cared for by APPs or HS. •. A specialized ASCT service using APPs may decrease inpatient test ...

5. bmcmedinformdecismak.biomedcentral.com bmcmedinformdecismak.biomedcentral.com/articles/10.1186/s12911-025-03133-1

AI-driven prognostics in pediatric bone marrow transplantation This study introduces a notable advancement in pediatric healthcare, specifically regarding the prognosis and classification of childhood BMT ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10452361/

Telemedicine in Hematopoietic Cell Transplantation and ... We review data on how telemedicine is being incorporated for patients who receive stem cell transplantation or cellular therapy.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666636722013082

eHealth-Generated Patient Data in an Outpatient Setting ... Collection of patient-reported outcomes was the most frequently reported eHealth intervention (n = 14; 63.6%), followed by vital sign monitoring (n = 5; 22.7%) ...

8. astctjournal.org astctjournal.org/article/S2666-6367(23)01546-4/fulltext

Predicting Patient Death after Allogeneic Stem Cell ... The 5-year survival was 94.7% in the 25% of patients at lowest risk and 62.3% in the 25% at highest risk. Within disease and donor subgroups, ...