Digital Health Intervention for Graft-versus-Host Disease

Overseen By Hanna Culang, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Cognitive impairment, Prisoners, Pregnant women, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app called Horizons to determine its usefulness for individuals who have undergone a specific type of stem cell transplant and are managing chronic graft-versus-host disease (GVHD). GVHD occurs when donor cells attack the recipient's body after a transplant. The trial seeks to assess whether the app is practical and beneficial for managing this condition. Participants must be patients at a specific cancer center, have moderate to severe GVHD, and be comfortable using an iPad. As an unphased trial, it provides a unique opportunity to contribute to innovative research that could enhance the quality of life for others with GVHD.

Will I have to stop taking my current medications?

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

What prior data suggests that the Horizons App is safe for survivors of allogeneic hematopoietic stem cell transplant with chronic graft-versus-host disease?

Research has shown that the Horizons mobile app is designed to improve emotional and physical well-being in people with chronic graft-versus-host disease (GVHD). As a digital tool rather than a medication, the Horizons app typically avoids the safety concerns associated with drugs.

Previous studies have examined the app's impact on quality of life, and no harmful side effects have been reported, as it is simply an app. Participants primarily use the app and complete surveys, indicating its user-friendly nature.

Overall, the app is considered safe because it does not involve physical treatments or medications. The goal is to determine if it can enhance emotional and physical well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Horizons App Intervention for graft-versus-host disease (GVHD) because it leverages digital health technology to provide support and management tools directly to patients. Unlike traditional treatments for GVHD, which often involve medications like immunosuppressants to manage symptoms, the Horizons app offers a non-pharmaceutical approach. It empowers patients with real-time information and tools to monitor their condition, potentially enhancing their quality of life and treatment adherence. This digital intervention could represent a significant shift towards more personalized and accessible care for individuals dealing with GVHD.

What evidence suggests that the Horizons App is effective for chronic graft-versus-host disease?

Research has shown that the Horizons mobile app might help people with chronic graft-versus-host disease (GVHD) feel better. This condition can cause various symptoms after a stem cell transplant, affecting both physical and emotional health. Early results suggest that the app could lessen symptoms and improve emotional well-being. Participants in this trial will use the Horizons mobile application for up to 6 weeks. The app focuses on providing support for stress and emotional challenges. Initial trials are examining how effectively this digital tool improves daily life. ^{1 2 3 5 6}

Who Is on the Research Team?

Lara Traeger, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for survivors of allogeneic hematopoietic stem cell transplant who are living with chronic graft-versus-host disease. Participants should be willing to complete surveys and use the Horizons mobile application.

Inclusion Criteria

I can communicate and understand English for study needs.

I have had a stem cell transplant from a donor.

I have moderate to severe chronic graft-versus-host disease.

Exclusion Criteria

Vulnerable patients, defined here as prisoners and pregnant women

Comorbid conditions or cognitive impairment that the treating clinician believes prohibits informed consent or participation in the intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Horizons mobile application and complete surveys

6 weeks

Follow-up

Participants are monitored for retention and enrollment metrics

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Horizons App Intervention

Trial Overview The study is testing whether the Horizons app can help improve quality of life for people with chronic graft-versus-host disease after a stem cell transplant. It involves using the app and completing surveys about their experience.

How Is the Trial Designed?

Group I: Horizons Digital Health Application Group Experimental Treatment 1 Intervention

Participants will receive the Horizons mobile application for up to 6 weeks.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

A new intervention module was developed to improve medication adherence for patients undergoing allogeneic stem cell transplantation, focusing on the implementation and persistence phases of adherence using a structured approach based on behavior change theories.

The intervention identified key behaviors and barriers related to immunosuppressant use, and selected specific strategies like education and goal setting to enhance adherence, which could serve as a model for future eHealth solutions in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Theory-driven development of a medication adherence intervention delivered by eHealth and transplant team in allogeneic stem cell transplantation: the SMILe implementation science project. Ribaut, J., Leppla, L., Teynor, A., et al.[2021]

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]

In a survey of 1377 allogeneic hematopoietic cell transplant survivors, those with moderate to severe chronic graft-versus-host disease reported significantly worse quality of life and higher symptom burden compared to those whose condition had resolved or who never had it.

A notable percentage (26.7-39.4%) of patients with active chronic graft-versus-host disease were unable to work due to health issues, highlighting the need for improved prevention and treatment strategies to enhance survivorship after transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes and health status associated with chronic graft-versus-host disease. Lee, SJ., Onstad, L., Chow, EJ., et al.[2019]

In a retrospective analysis of a randomized clinical trial involving patients undergoing hematopoietic cell transplantation, tacrolimus/methotrexate showed less skin morbidity and a trend toward less liver morbidity compared to cyclosporine/methotrexate, indicating potential benefits in managing acute graft-versus-host disease (GVHD).

Despite these findings, the study highlighted that objective assessments of morbidity related to GVHD have limited utility in demonstrating clinical benefits, emphasizing the need for blinded assessments in future trials to better evaluate treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal assessment of morbidity and acute graft-versus-host disease after allogeneic hematopoietic cell transplantation: retrospective analysis of a multicenter phase III study. Carnevale-Schianca, F., Leisenring, W., Martin, PJ., et al.[2021]

The Lee Chronic Graft-versus-Host Disease (cGVHD) Symptom Scale is a reliable and valid tool for capturing cGVHD symptoms, as confirmed by a study involving 20 adult patients with varying severity of the condition.

Participants found the scale to be clear and comprehensive, although some suggested improvements for specific skin-related items and the recall period for symptoms, indicating ongoing refinement is needed for optimal use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Content Validity of the Lee Chronic Graft-versus-Host Disease Symptom Scale as Assessed by Cognitive Interviews. Merkel, EC., Mitchell, SA., Lee, SJ.[2019]

A new web-based data entry system has been developed to standardize the clinical staging of acute graft-versus-host disease (GVHD) across multiple bone marrow transplant centers, addressing significant variability in practices.

This user-friendly system improves accuracy in documenting symptoms and therapeutic responses, which can enhance the quality of data collected in multicenter trials aimed at preventing and treating acute GVHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved accuracy of acute graft-versus-host disease staging among multiple centers. Levine, JE., Hogan, WJ., Harris, AC., et al.[2018]

The eGVHD App significantly reduces discrepancies in scoring the severity of chronic graft-versus-host disease (GVHD), with a 38% discrepancy rate compared to 9% for acute GVHD when not using the App, highlighting its effectiveness in standardizing assessments.

User satisfaction with the eGVHD App is high, as indicated by median scores of 6 for perceived usefulness and 2 for usability, making it a valuable tool for managing GVHD in bone marrow transplant centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of eGVHD App for bedside GVHD assessment in a high-volume BMT center. Chhabra, P., Kasudhan, KS., Khaire, N., et al.[2023]

This study evaluated six different strategies for preventing graft-versus-host disease (GVHD) after hematopoietic cell transplantation (HCT) by comparing their effectiveness against a large multicenter outcomes database, highlighting the importance of using comprehensive data for selecting promising interventions.

The research introduced novel composite endpoints, such as graft-versus-host disease, relapse-free survival (GRFS), and chronic GVHD, relapse-free survival (CRFS), which can enhance the design of future clinical trials aimed at improving GVHD prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood and Marrow Transplant Clinical Trials Network Report on the Development of Novel Endpoints and Selection of Promising Approaches for Graft-versus-Host Disease Prevention Trials. Pasquini, MC., Logan, B., Jones, RJ., et al.[2021]

Citations

1. trialx.com trialx.com/clinical-trials/listings/224662/psychosocial-mobile-app-for-chronic-graft-versus-host-disease/

Psychosocial Mobile App for Chronic Graft-Versus-Host ... Overview. The purpose of this research study is to see whether a psychosocial mobile app called Horizons is effective at improving quality ...

2. trial.medpath.com trial.medpath.com/clinical-trial/d99b216648905a4a/nct05690971-randomized-trial-psychosocial-app-chronic-gvhd

Psychosocial Mobile App for Chronic Graft-Versus-Host Disease The purpose of this research study is to see whether a psychosocial mobile app called Horizons is effective at improving quality of life, symptom burden, ...

3. withpower.com withpower.com/trial/phase-graft-vs-host-disease-2023-6b656

Mobile App for Chronic Graft-Versus-Host Disease This trial is testing a mobile app called Horizons to see if it can help people with chronic GVHD feel better emotionally and physically.

4. massgeneral.trialstoday.org massgeneral.trialstoday.org/trial/NCT05690971

Psychosocial Mobile App for Chronic Graft-Versus-Host ... Purpose. The purpose of this research study is to see whether a psychosocial mobile app called Horizons is effective at improving quality of ...

5. app.trialscreen.org app.trialscreen.org/trials/digital-health-intervention-to-promote-quality-life-adults-chronic-graft-trial-nct06688942

Digital Health Intervention for Chronic Graft Versus Host ... This Interventional study is looking for people with Chronic Graft-Versus-Host Disease, Quality of Life in Miami United States to take part.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6165809/

The eGVHD App has the potential to improve the accuracy ... The eGVHD App shows superior GvHD assessment accuracy compared to standard practice and has the potential to improve the quality of outcome data registration in ...