Trials / Recruiting

RecruitingNCT07314892

Psychiatric Status and Symptom Severity in Graft-versus-Host Disease (GvHD).

Prospective Assessment of the Impact of Psychiatric Status on Clinical Symptom Severity in Patients With Graft-versus-Host Disease (GvHD).

Status: Recruiting
Phase: —
Study type: Observational
Enrollment: 200 (estimated)

Sponsor: Medical University of Gdansk · Academic / Other
Sex: All
Age: 18 Years – 75 Years
Healthy volunteers: Not accepted

Summary

This prospective observational study evaluates the association between psychiatric status, GvHD-related symptom severity, and health-related quality of life in patients with graft-versus-host disease. Standardized and validated assessment tools, including the Lee Symptom Scale, will be used to collect psychiatric, clinical, and demographic data.

Detailed description

Graft-versus-host disease (GvHD) is a significant complication following allogeneic hematopoietic stem cell transplantation and is associated with substantial symptom burden, impaired quality of life, and increased psychiatric morbidity. Despite its clinical relevance, the relationship between psychiatric status and the severity of GvHD-related symptoms remains insufficiently characterized. This prospective observational study aims to systematically assess psychiatric status, symptom severity, and health-related quality of life in patients with GvHD using standardized and validated instruments. Demographic and clinical data will be collected to establish a comprehensive patient registry. The study will evaluate the association between psychiatric disorders and the intensity of GvHD-related symptoms, as measured by the Lee Symptom Scale, and will explore the bidirectional relationship between depressive symptoms and the clinical course of GvHD. The findings are expected to inform the development of evidence-based recommendations for therapeutic support aimed at improving clinical outcomes and quality of life in patients with GvHD.

Conditions

Timeline

Start date: 2025-04-08
Primary completion: 2028-04-01
Completion: 2028-10-01
First posted: 2026-01-02
Last updated: 2026-01-02

Locations

1 site across 1 country: Poland

Source: ClinicalTrials.gov record NCT07314892. Inclusion in this directory is not an endorsement.