Chronic graft-versus-host disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT) for a hematologic disease; 2.Diagnosed with cGVHD during the follow-up period by an outpatient physician. (The diagnosis of cGVHD relies primarily on clinical manifestations, based on the diagnostic signs outlined in the National Institutes of Health (NIH) Consensus Criteria, as detailed in Appendix Tables 1 and 2); 3. Self-reports experiencing active cGVHD symptoms; 4.Aged >=16 years and <=75 years, and possesses basic literacy and comprehension skills; 5.Volunteers to participate in this study, agrees to the 6-month follow-up, and is able to cooperate with the follow-up personnel.
Exclusion criteria
Exclusion criteria: 1. Incomplete records of transplantation-related information or inability to obtain the allo-HSCT medical records from the external hospital where the procedure was performed; 2. History of psychiatric disorders, experience of major life events, or history of insomnia either before or after transplantation; 3. Anticipated inability to complete the 6-month follow-up (e.g., due to excessive geographical distance, planned relocation, or poor compliance).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the Lee Symptom Scale (LSS) score from baseline to 6 months.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative incidence of treatment-related adverse events within 6 months;;Response rate of chronic GVHD at 6 months;Improvement from baseline in SF-36, FACT-BMT, and EQ-5D-5L scores at 6 months;Incidence and primary reasons for protocol adjustments during the treatment period; | — |
Countries
China
Contacts
The Second Affiliated Hospital of the Army Medical University