Department of Hematology and Transplantology
Gdansk, Pomeranian Voivodeship, 80-214, Poland
Location status: Recruiting
NCT Number: NCT07314892
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Observational
Gdansk, Pomeranian Voivodeship, 80-214, Poland
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline and follow-up assessments during the study period (up to 12 months).
Time frame: Baseline and follow-up assessments during the study period (up to 12 months).
Time frame: Baseline and follow-up assessments during the study period (up to 12 months).
Contact information is provided by the study sponsor or research team.
Agnieszka Piekarska, MD PhD
CONTACT
Jan Puchowski, M.D.
CONTACT
Medical University of Gdansk
Other
Prospective Assessment of the Impact of Psychiatric Status on Clinical Symptom Severity in Patients With Graft-versus-Host Disease (GvHD).
Acronym: Psych-GvHD
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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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