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Active, Not Recruiting

NCT Number: NCT05690971

Psychosocial Mobile App for Chronic Graft-Versus-Host Disease

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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Graft-versus-host Disease Allogeneic Stem Cell Transplant Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

App

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Quality of life (QOL): Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)

    Time frame: 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 outcomes

  1. Quality of life (QOL) longitudinal using FACT-BMT

    Time frame: 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.

  2. Anxiety symptoms using the Hospital Anxiety and Depression Scale (HADS-Anxiety)

    Time frame: 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

  3. Depression symptoms using HADS-Depression

    Time frame: 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

  4. Chronic GVHD symptom burden (Lee Scale)

    Time frame: 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

Other outcomes

  1. Self-efficacy (PROMIS self-efficacy scale)

    Time frame: up to sixteen weeks

    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

  2. patient coping using Measure of Current Status (MOCS)

    Time frame: up to sixteen weeks

    Comparing coping (MOCS) between study groups (MOCS score range 0-52, with higher scores indicating greater coping skill).

  3. social support using Medical Outcomes Study Social Support Survey (MOS SSS)

    Time frame: up to sixteen weeks

    Compare patient social support (MOS SSS) between study groups. MOS SSS score range 0-100, with higher scores indicating greater support.

  4. Usability of the Horizons app using the system usability scale

    Time frame: eight weeks

    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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • The Leukemia and Lymphoma Society

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jan 19, 2023
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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