What side effects are associated with this type of intervention?

Common treatments for Graft-versus-Host Disease (GVHD) include immunosuppressive drugs such as cyclosporine, mycophenolate mofetil, and glucocorticoids. These treatments can have significant side effects. Cyclosporine may cause kidney dysfunction, hypertension, and increased risk of infections. Mycophenolate mofetil can lead to gastrointestinal issues, bone marrow suppression, and increased susceptibility to infections. Glucocorticoids are associated with weight gain, osteoporosis, hyperglycemia, and mood changes. Psychosocial support and cognitive-behavioral strategies, like those studied in the Horizons Mobile App, aim to improve quality of life and reduce psychological distress without the physical side effects of pharmacological treatments.

What prior FDA approvals exist?

FDA-approved treatments for Graft-versus-Host Disease (GVHD) primarily include pharmacological interventions such as corticosteroids, ruxolitinib, and ibrutinib. These treatments focus on modulating the immune response to reduce the severity of GVHD. While the Horizons Mobile App trial is studying the impact of psychosocial support and cognitive-behavioral strategies on improving quality of life and symptom burden in GVHD patients, these non-pharmacological approaches are not typically the focus of FDA approvals. However, they are recognized as important complementary therapies that can enhance overall patient well-being and coping mechanisms.

What other types of research exist?

Promising novel alternatives to the Horizons Mobile App for GvHD patients in 2024 may include virtual reality (VR) therapy for immersive stress relief and pain management, AI-driven personalized mental health apps that offer tailored cognitive-behavioral therapy (CBT) sessions, and telehealth platforms providing real-time support from mental health professionals. Additionally, integration of wearable technology to monitor physiological responses and provide biofeedback for stress management could be beneficial.

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Behavioral Intervention

Mobile App for Chronic Graft-Versus-Host Disease

N/A

Recruiting

Led By Areej El-Jawahri, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult patients (≥18 years) who underwent allogeneic hematopoietic stem cell transplant (HCT)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to sixteen weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves a psychosocial app rather than medication, traditional physical side effects are not expected. However, users may experience emotional discomfort or stress while engaging with the content.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to sixteen weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to sixteen weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to sixteen weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Quality of life (QOL): Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)

Secondary study objectives

Anxiety symptoms using the Hospital Anxiety and Depression Scale (HADS-Anxiety)

Chronic GVHD symptom burden (Lee Scale)

Depression symptoms using HADS-Depression

+1 more

Other study objectives

Self-efficacy (PROMIS self-efficacy scale)

Usability of the Horizons app using the system usability scale

patient coping using Measure of Current Status (MOCS)

+1 more

Side effects data

From 2017 Phase 4 trial • 134 Patients • NCT02858713

12%

Skin manifestations

various musculoskelatal disorders

Lung and skin infections

Nausea

Elevated liver enzymes

Worsening of chronic obstructive pumonary disease (COPD)

Fainting

100%

80%

60%

40%

20%

Study treatment Arm

Conventional Instructions + App as Intervention + Enstilar©

App as Intervention + Enstilar©

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Horizons mobile appExperimental Treatment1 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 CareActive Control1 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

App

2018

Completed Phase 4

~470

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Graft-versus-Host Disease (GVHD) include immunosuppressive agents such as corticosteroids, calcineurin inhibitors (e.g., cyclosporine, tacrolimus), and biologics like monoclonal antibodies. These treatments work by dampening the immune response to prevent donor immune cells from attacking the recipient's tissues. This is crucial for GVHD patients as it helps to reduce inflammation and tissue damage, improving overall survival and quality of life. Additionally, psychosocial support and cognitive-behavioral strategies, like those studied in the Horizons Mobile App trial, are important as they help patients manage the psychological distress and improve coping mechanisms, which can significantly enhance their quality of life and treatment adherence.

Multimodal psychosocial intervention for family caregivers of patients undergoing hematopoietic stem cell transplantation: A randomized clinical trial.