Psychosocial Mobile App for Chronic Graft-Versus-Host Disease

Study Overview
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Brief Summary
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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, psychological distress, and coping in patients living with chronic graft-versus host disease (GVHD)

Detailed Description
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Frequently patients living with chronic GVHD experience physical and emotional symptoms during the course of illness that impacts their quality of life. Patients also often report difficulty managing many of the tasks they need to do to manage their chronic GVHD. They also frequently have a lot of questions about chronic GVHD and the expected trajectory of this illness. 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, and psychological distress in patients with chronic GVHD This study will randomly assign participants to either receiving Horizons plus usual care or usual care alone. Enrolled participants will be on the research study for up to sixteen weeks and it is expected that about 120 people will take part in this research study. The Leukemia and Lymphoma Society is supporting this research by providing funding.

Official Title
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Randomized Controlled Trial of a Psychosocial Mobile Application (App) to Promote Coping for Patients With Chronic Graft-Versus-Host Disease (GVHD)

Conditions
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Chronic Graft-Versus-Host Disease, Allogeneic Stem Cell Transplant

Intervention / Treatment
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* Behavioral: App
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (≥18 years) who underwent allogeneic hematopoietic stem cell transplant (HCT). Have moderate to severe chronic GVHD based on their oncology clinician assessment as documented in the Electronic Health Record. Ability to comprehend and speak English as the HORIZONs app is only available in English. Exclusion Criteria: -Patients with acute or unstable psychiatric or cognitive conditions which the treating clinicians believes prohibits informed consent or compliance with study procedures.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Horizons mobile app<br>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 | Behavioral: App<br>* HORIZONS is self-administered with several features to promote engagement and health behavior change including gamification strategies, videos of chronic GVHD survivors, and optional content. HORIZONS includes five interactive modules to be completed during an eight week period. HORIZONS also includes a sixth optional helpful resources section with a review of the domains and skills covered in the first five modules<br>|
| Active Comparator: Usual Care<br>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 | Behavioral: Usual Care<br>* Patients 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (QOL): Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) | Compare patient QOL (FACT-BMT) between usual care and Horizon at 8 weeks using ANCOVA. FACT-BMT score range 0-164, with higher scores indicating better quality of life. | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (QOL) longitudinal using FACT-BMT | Compare patient QOL (FACT-BMT) longitudinally between Horizons and usual care group using mixed linear effect models. FACT-BMT score range 0-164, with higher scores indicating better quality of life. | Up to sixteen weeks | 
| Anxiety symptoms using the Hospital Anxiety and Depression Scale (HADS-Anxiety) | Compare anxiety symptoms (HADS-Anxiety) between study groups. The HADS anxiety subscale range from 0-21 with higher scores indicating worse anxiety symptoms | up to sixteen weeks | 
| Depression symptoms using HADS-Depression | Compare depression symptoms (HADS-depression) between study groups. The HADS depression subscale range from 0-21 with higher scores indicating worse depression symptoms | up to sixteen weeks | 
| Chronic GVHD symptom burden (Lee Scale) | compare chronic GVHD symptom burden (Lee Scale) between the study groups. The Lee Scale ranges from 0-100 with higher scores indicating worse symptom burden | up to sixteen weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Graft-Versus-Host Disease, Allogeneic Stem Cell Transplant