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

Trial Summary

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 data supports the effectiveness of the treatment App-based Educational Intervention for Bone Marrow Transplant Complications?

Research on similar mobile health apps for bone marrow transplant patients shows that these apps can help track symptoms and improve health outcomes by allowing earlier detection of problems. For example, the TRU-BMT app showed that better adherence was linked to improved meal completion, lower heart rates, and shorter hospital stays. ^{1 2 3 4 5}

Is the app-based educational intervention safe for humans?

The app-based educational interventions, like QuestLeukemia and BMT4me©, have been found to be safe and well-received by patients, parents, and healthcare providers in studies involving children undergoing hematopoietic stem cell transplantation. These apps were reported to be easy to use, enjoyable, and helpful in managing treatment, with no safety concerns mentioned. ^{1 6 7 8 9}

How does the App-based Educational Intervention treatment differ from other treatments for bone marrow transplant complications?

The App-based Educational Intervention is unique because it uses a mobile app to educate patients about bone marrow transplant complications, aiming to increase their understanding and autonomy over their treatment process. Unlike traditional treatments, this app provides interactive educational content, such as videos and quizzes, to help patients manage their condition more effectively. ^{1 6 7 8 10}

What is the purpose of this trial?

This randomized, phase I/II, open-label study will investigate the efficacy and safety of an educational sleep intervention vs standard of care in adults undergoing alloHSCT. The randomization target in this pilot phase is 60 patients.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

References

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

Assessing the Feasibility of a Novel mHealth App in Hematopoietic Stem Cell Transplant Patients. [2023]

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

Hybrid-delivered cognitive behavioral symptom management and activity coaching intervention for patients undergoing hematopoietic stem cell transplant: Findings from intervention development and a pilot randomized trial. [2023]

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

Application and Evaluation of Survivorship Care Guides for Hematopoietic Cell Transplantation Recipients. [2021]

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

Health Information Technology Utilization by Adolescent and Young Adult Aged Inpatients Undergoing Hematopoietic Cell Transplantation. [2022]

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

Patient education in allogeneic hematopoietic cell transplant: what patients wish they had known about quality of life. [2021]

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

eHealth-Generated Patient Data in an Outpatient Setting after Hematopoietic Stem Cell Transplantation: A Scoping Review. [2022]

7. 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]

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

Improving medication adherence monitoring and clinical outcomes through mHealth: A randomized controlled trial protocol in pediatric stem cell transplant. [2023]

9. United States 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. [2023]

10. Canada 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. [2021]