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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
Study Summary
This trial is studying if an app can help people living with chronic GVHD improve their quality of life, symptoms, mental health, and coping.
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.Check my eligibility
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.See study design
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 belowSelect...
I am an adult who has had a stem cell transplant from another person.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ eight weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~eight weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Quality of life (QOL): Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)
Secondary outcome measures
Anxiety symptoms using the Hospital Anxiety and Depression Scale (HADS-Anxiety)
Chronic GVHD symptom burden (Lee Scale)
Depression symptoms using HADS-Depression
+1 moreOther outcome measures
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 moreSide effects data
From 2017 Phase 4 trial • 134 Patients • NCT0285871312%
Skin manifestations
6%
various musculoskelatal disorders
6%
Lung and skin infections
1%
Elevated creatinin levels
1%
relapse of carcinoma in situ of the glottis
1%
Nausea
1%
Elevated liver enzymes
1%
Infection in knee prosthesis
100%
80%
60%
40%
20%
0%
Study treatment Arm
App as Intervention + Enstilar©
Conventional Instructions + App as Intervention + Enstilar©
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
~370
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,935 Previous Clinical Trials
13,198,521 Total Patients Enrolled
The Leukemia and Lymphoma SocietyOTHER
82 Previous Clinical Trials
17,011 Total Patients Enrolled
Areej El-Jawahri, MDPrincipal InvestigatorMassachusetts General Hospital
18 Previous Clinical Trials
4,392 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.
Research Study Groups:
This trial has the following groups:- Group 1: Horizons mobile app
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment into this trial currently open?
"Clinicaltrials.gov confirms that this medical trial, which was initially posted on January 30th 2023 and last updated on January 10th of the same year, is not in its recruitment phase any longer. However, there are still 173 other clinical trials searching for participants at present."
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