Psychosocial Mobile App for Chronic Graft-Versus-Host Disease

Not Applicable

Recruiting

• Conditions: Chronic Graft-Versus-Host Disease; Allogeneic Stem Cell Transplant
• Interventions: Behavioral: App; Behavioral: Usual Care

• Registration Number: NCT05690971
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2023-01-10
• Study First Submitted QC: 2023-01-10
• Study First Posted: 2023-01-19
• Study Start: 2023-01-23
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-03
• Primary Completion: 2024-09-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Horizons mobile app	App	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
Usual Care	Usual Care	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

Primary Outcome Measures

Name	Time	Method
Quality of life (QOL): Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)	8 Weeks	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.

Secondary Outcome Measures

Name	Time	Method
Depression symptoms using HADS-Depression	up to sixteen weeks	Compare depression symptoms (HADS-depression) between study groups. The HADS depression subscale range from 0-21 with higher scores indicating worse depression symptoms
Anxiety symptoms using the Hospital Anxiety and Depression Scale (HADS-Anxiety)	up to sixteen weeks	Compare anxiety symptoms (HADS-Anxiety) between study groups. The HADS anxiety subscale range from 0-21 with higher scores indicating worse anxiety symptoms
Chronic GVHD symptom burden (Lee Scale)	up to sixteen weeks	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
Quality of life (QOL) longitudinal using FACT-BMT	Up to sixteen weeks	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.

Trial Locations

Locations (1)

Massachusetts General Hospital Cancer Center; 🇺🇸 Boston, Massachusetts, United States