Mobile App for Chronic Graft-Versus-Host Disease

Overseen By Areej El-Jawahri, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Acute psychiatric, Unstable cognitive, others

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

Compensation: Varies

Number of Visits: 3

Duration: 16 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a mobile app called Horizons to see if it can help people with chronic GVHD feel better emotionally and physically. The app aims to improve their quality of life by providing support and information. Participants will use the app along with their usual care for several months.

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 seems focused on using a mobile app to improve quality of life for those with chronic GVHD.

What data supports the effectiveness of the treatment Horizons for chronic graft-versus-host disease?

The eGVHD App, which is used to assess chronic graft-versus-host disease, showed high user satisfaction and improved accuracy in scoring the severity of the disease, suggesting it could be a useful tool in managing the condition. Additionally, response rates in chronic graft-versus-host disease were associated with changes in symptom burden, indicating potential clinical benefits. ^{1 2 3 4 5}

Is the eGVHD App safe for use in managing graft-versus-host disease?

The eGVHD App has been used in multiple studies to improve the accuracy of graft-versus-host disease assessment, and it has shown high user satisfaction and perceived usefulness. There are no specific safety concerns reported in the studies, indicating it is generally safe for use in managing this condition. ^{1 3 6 7 8}

How does the Horizons treatment for chronic graft-versus-host disease differ from other treatments?

The Horizons treatment is unique because it involves a mobile app that helps healthcare professionals accurately assess the severity of chronic graft-versus-host disease, improving consistency and accuracy compared to traditional methods. ^{1 3 8 9 10}

Research Team

Areej El-Jawahri, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults over 18 who had a stem cell transplant and are now living with moderate to severe chronic graft-versus-host disease (GVHD). Participants must understand and speak English, as the app being tested is only in English. Those with acute psychiatric or cognitive conditions that affect consent or study compliance cannot join.

Inclusion Criteria

I am an adult who has had a stem cell transplant from another person.

My doctor has documented that I have moderate to severe chronic GVHD in my health records.

Exclusion Criteria

Patients with acute or unstable psychiatric or cognitive conditions which the treating clinicians believe 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 are randomly assigned to either the Horizons app plus usual care or usual care alone for up to sixteen weeks

16 weeks

3 visits (virtual) at baseline, 8 weeks, and 16 weeks

Follow-up

Participants are monitored for quality of life, symptom burden, and psychological distress after treatment

4 weeks

Treatment Details

Interventions

• Horizons
• Usual Care

Trial Overview The study tests a psychosocial mobile app called Horizons, designed to help improve life quality, reduce symptom burden, ease psychological distress, and enhance coping skills in patients with chronic GVHD after stem cell transplantation.

Participant Groups

Group I: Horizons mobile app Experimental Treatment 1 Intervention

Participants randomly assigned to the Horizons group, will use the Horizons app over an eight-week period in addition to receiving usual care from transplant team. Participants will complete study questionnaires at the time of enrollment (baseline) and at eight and sixteen weeks after enrollment

Group II: Usual Care Active Control 1 Intervention

Participant in the usual care group will receive usual care from the transplant oncology team including all the supportive care measures implemented by the transplant oncology team. Participants will complete study questionnaires at the time of enrollment (baseline) nad at eight and sixteen weeks after enrollment

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

The Leukemia and Lymphoma Society

Collaborator

Trials

87

Recruited

26,200+

Findings from Research

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]

Changes in chronic graft-versus-host disease (cGVHD) symptoms, specifically in the eyes, joints, and mouth, from baseline to 6 months can provide insights into longer-term treatment outcomes, but their predictive accuracy is currently insufficient for clinical trials.

The study, which analyzed data from two multicenter observational studies, found that only 45% of patients achieved failure-free survival within two years, highlighting the need for better biomarkers to improve predictions of long-term outcomes in cGVHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Chronic Graft-versus-Host Disease Failure-Free Survival (cGVHD-FFS) Index. Pidala, JA., Hamilton, BK., Martin, PJ., et al.[2021]

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]

In a study of 283 patients with chronic graft-versus-host disease, a 6-month overall response rate of 32% was observed, with varying organ-specific response rates, indicating some effectiveness of systemic treatments.

While changes in objective response measures correlated with symptom burden, they did not correlate with improvements in quality of life or survival outcomes, suggesting a need for better clinical endpoints in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical benefit of response in chronic graft-versus-host disease. Inamoto, Y., Martin, PJ., Chai, X., et al.[2021]

A new grading system for chronic graft-versus-host disease (cGVHD) was developed using data from 1827 transplant recipients, identifying key factors like performance score and organ involvement that predict survival outcomes.

While cGVHD is linked to fewer relapses in patients (with a relative risk of 0.5-0.6), it also increases treatment-related mortality (relative risk of 1.8-2.8), indicating a complex relationship between cGVHD severity and patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severity of chronic graft-versus-host disease: association with treatment-related mortality and relapse. Lee, SJ., Klein, JP., Barrett, AJ., et al.[2022]

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]

A pilot study involving 66 adult patients undergoing allogeneic hematopoietic cell transplantation showed that those who developed acute graft-versus-host disease (GVHD) reported significantly lower quality of life (QOL) scores compared to those with no or mild GVHD, highlighting the severe impact of acute GVHD on patient well-being.

The study successfully utilized patient-reported outcome measures (PROMIS-10 and PRO-CTCAE) to capture prevalent symptoms in patients with grade 2-4 acute GVHD, such as fatigue, decreased appetite, and depression, indicating the potential for these tools to assess symptom burden and QOL in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Trial of Patient-Reported Outcomes for Acute Graft-Versus-Host-Disease. Patel, SS., Hong, S., Rybicki, L., et al.[2023]

The eGVHD App significantly improves the accuracy of assessing graft-versus-host disease (GvHD) severity compared to traditional methods, with healthcare professionals using the app being over six times more likely to correctly diagnose and score GvHD.

Despite taking an average of 24 minutes longer to complete assessments, the app received positive usability feedback and demonstrated better inter-observer agreement, indicating its potential to enhance outcome data quality in allogeneic stem cell transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The eGVHD App has the potential to improve the accuracy of graft-versus-host disease assessment: a multicenter randomized controlled trial. Schoemans, HM., Goris, K., Van Durm, R., et al.[2019]

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 study of 24 adults with chronic graft-versus-host disease (cGVHD), higher levels of cytokines, particularly interleukin-6, were associated with more severe symptoms like lack of energy and dry mouth, indicating a potential biological mechanism linking inflammation to symptom severity.

The research highlighted that multiple concurrent symptoms negatively impact the quality of life (QOL) for patients with cGVHD, suggesting a need for targeted interventions to manage these symptoms effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptoms, Cytokines, and Quality of Life in Patients Diagnosed with Chronic Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation. Lynch Kelly, D., Lyon, DE., Ameringer, SA., et al.[2022]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Utility of eGVHD App for bedside GVHD assessment in a high-volume BMT center. [2023]

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

The Chronic Graft-versus-Host Disease Failure-Free Survival (cGVHD-FFS) Index. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Improved accuracy of acute graft-versus-host disease staging among multiple centers. [2018]

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

Clinical benefit of response in chronic graft-versus-host disease. [2021]

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

Severity of chronic graft-versus-host disease: association with treatment-related mortality and relapse. [2022]

6. 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]

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

A Pilot Trial of Patient-Reported Outcomes for Acute Graft-Versus-Host-Disease. [2023]

8. Italy pubmed.ncbi.nlm.nih.gov

The eGVHD App has the potential to improve the accuracy of graft-versus-host disease assessment: a multicenter randomized controlled trial. [2019]

9. Italy pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes and health status associated with chronic graft-versus-host disease. [2019]

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

Symptoms, Cytokines, and Quality of Life in Patients Diagnosed with Chronic Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation. [2022]