Psychosocial Mobile App for Chronic Graft-Versus-Host Disease

Chronic Graft-Versus-Host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05690971
• Other study ID #: 22-503
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2023
• Est. completion date: April 1, 2025

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: Areej El-Jawahri, MD
• Phone: 617-643-4003
• Email: AEL-JAWAHRI[@]PARTNERS.ORG
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Allogeneic Stem Cell Transplant
• Bronchiolitis Obliterans Syndrome
• Chronic Graft-Versus-Host Disease
• Graft vs Host Disease

Intervention

Behavioral:
• App
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
• Usual Care
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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	The Leukemia and Lymphoma Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-efficacy (PROMIS self-efficacy scale)	Compare self-efficacy (PROMIS-self-efficacy scale) between the study groups. The PROMIS self-efficacy for managing symptoms scale ranges from 0-100 with higher scores indicating better self-efficacy	up to sixteen weeks
Other	patient coping using Measure of Current Status (MOCS)	Comparing coping (MOCS) between study groups (MOCS score range 0-52, with higher scores indicating greater coping skill).	up to sixteen weeks
Other	social support using Medical Outcomes Study Social Support Survey (MOS SSS)	Compare patient social support (MOS SSS) between study groups. MOS SSS score range 0-100, with higher scores indicating greater support.	up to sixteen weeks
Other	Usability of the Horizons app using the system usability scale	We will use the system usability scale at 8 weeks post-intervention (for those randomized to Horizons) to assess the usability of HORIZONS. the system usability scale score range from 0-100 with higher scores indicating better usability	eight weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	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