Short summary

A serious complication after allogeneic hematopoietec cell transplantation in patients with hematological diseases is chronic graft-versus-host-disease (cGVDH). Identifying cGVHD symptoms during routine out-patient visits are time consuming. The use of patient-reported outcome measurements may ease this and also facilitate shared-decision-making processes.

The aim is to investigate the psychometric properties (construct validity and reliability) of the Danish version of the Lee cGVHD Symptom Scale.

Rationale

A serious complication after allogeneic hematopoietec cell transplantation (HCT) in patients with hematological diseases is chronic graft-versus-host-disease (cGVDH). Identifying cGVHD symptoms during routine out-patient visits are time consuming.

Although specific PROMs have been developed to capture signs and symptoms of cGVHD after allogeneic HCT, no studies have been published on the efficacy of electronic capture of PRO data in the outpatient setting. As current practice of diagnosing cGVHD symptoms is not carried out in a systematic way, electronic capture of PRO may improve the diagnosis and extent of cGVHD manifestations from the patient perspective. Additionally, integration of PROs into clinical practice seems to enhance the communication between the patients and health care professionals.

A PROM that identifies signs and symptoms of cGVHD in patients undergoing allogeneic HCT may be useful. Such PROM, the Lee cGVHD Symptom Scale, was developed more than 15 years ago. Nonetheless, the content validity of this PROM was recently confirmed and thus, a PROM still capable of capturing most of cGVHD symptoms.

However, the Lee cGVHD Symptom Scale is not available in Danish. Therefore, the aim is to investigate the psychometric properties (construct validity and reliability) of the Danish version of the Lee cGVHD Symptom Scale.

Description of the cohort

The overall eligibility criteria for participation in this study are adults with a hematologic cancer disease, aged >=18 years, able to understand and read Danish, +100 days post-transplantation and diagnosed with cGVHD per the 2014 NIH consensus criteria and symptomatic with active cGVHD with an NIH score>1 in one or more organs associated with active cGVHD.

In addition, participants should have sufficient cognitive function (subjectively decided by a responsible healthcare professional) and give written informed consent.

Data and biological material

Participants will be asked to answer questions related to sociodemographic data (e.g. age, sex, educational level (no formal education; vocational education; higher education), employment status (work full time, work part time, retired, sick leave due to cGVHD, sick leave due to other than cGVHD, unemployed (looking for work), other).

Additionally, physician-reported baseline data will be extracted from the medical journal of the patient. The physician-reported data include; cancer diagnosis at transplantation, time from diagnosis to transplantation, time since transplantation, graft type (peripheral stem cell, bone marrow, umbilical cord), graft rejection (yes/no), donor type (related, unrelated, matched, mismatched), type of GVHD prophylaxis, conditioning, cGVHD symptom severity at enrollment (mild, moderate, severe), initial organ involvement, number og GVHD sites involved at enrollment.

additionally, the participants will complete the Patient-reported outcome instruments, the Lee Symptom Scale, the EORTC QLQ-C30 and symptom specific items from the PRO-CTCAE item library bank. The PROs will be collected at baseline (T0) and seven days later (T1).

Collaborating researchers and departments

Department of Hematology Rigshospitalet, Copenhagen

• Brian Thomas Kornblit
• Maria Torp Larsen
• Mary Jarden