Psychosocial Mobile App for Chronic Graft-Versus-Host Disease

Mass General Brigham

Status: Active, not recruiting

Conditions: Chronic Graft-Versus-Host Disease; Allogeneic Stem Cell Transplant

Treatments: Behavioral: Usual Care; Behavioral: App

Study type: Interventional

Funder types: Other

Identifiers

NCT05690971

22-503

Details and patient eligibility

About

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)

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Horizons mobile app

Experimental group

Description:

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

Treatment:

Behavioral: App

Usual Care

Active Comparator group

Description:

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:

Behavioral: Usual Care