Clinical trial NCT05690971: Psychosocial Mobile App for Chronic Graft-Versus-Host Disease
Official title: Randomized Controlled Trial of a Psychosocial Mobile Application (App) to Promote Coping for Patients With Chronic Graft-Versus-Host Disease (GVHD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Graft-Versus-Host Disease
Allogeneic Stem Cell Transplant
Keywords: Chronic Graft-Versus-Host Disease
Allogeneic Stem Cell Transplant
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: The Leukemia and Lymphoma Society
First posted: 2023-01-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life (QOL): Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)
timeFrame: 8 Weeks
Secondary outcomes:
measure: Quality of life (QOL) longitudinal using FACT-BMT
timeFrame: Up to sixteen weeks
measure: Anxiety symptoms using the Hospital Anxiety and Depression Scale (HADS-Anxiety)
timeFrame: up to sixteen weeks
measure: Depression symptoms using HADS-Depression
timeFrame: up to sixteen weeks
measure: Chronic GVHD symptom burden (Lee Scale)
timeFrame: up to sixteen weeks
Other outcomes:
measure: Self-efficacy (PROMIS self-efficacy scale)
timeFrame: up to sixteen weeks
measure: patient coping using Measure of Current Status (MOCS)
timeFrame: up to sixteen weeks
measure: social support using Medical Outcomes Study Social Support Survey (MOS SSS)
timeFrame: up to sixteen weeks
measure: Usability of the Horizons app using the system usability scale
timeFrame: eight weeks
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Areej El-Jawahri, MD
role: PRINCIPAL_INVESTIGATOR
References: