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Pediatric cGVHD Symptom Scale Study

This observational study aims to create a better way to measure how chronic graft-versus-host-disease (cGVHD) symptoms affect children and teenagers. cGVHD is a side effect that can happen after a stem cell transplant, causing various bothersome symptoms. Currently, the questionnaires used to understand these symptoms are designed for adults, but children may describe their experiences differently. This study will develop a new questionnaire, called The Pediatric cGHVD Symptom Scale, specifically for young people aged 5 to 17 who have cGVHD. The goal is to identify their symptoms and understand how bothersome they are. The study is looking to enroll 139 participants and is currently unclear on its recruitment status.

Study design
This is an observational study with a planned enrollment of 139 participants, aged 5 to 99 years old, who have chronic graft-versus-host-disease (cGVHD).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The feasibility of the new questionnaire will be measured at 3 years.

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NCT04044365

Pediatric cGVHD Symptom Scale

Active, Not Recruiting
Not specifiedAges 5–99Observational
National Cancer Institute (NCI)
~139 participants
Updated 2026-08-10 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasability
Measured over 3 years

Conditions

Graft vs Host Disease

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Graft Versus Host Disease

Where it's being run

17 sites across 14 states
Maryland2
Texas2
Canada2
Arizona1
California1
Colorado1
District of Columbia1
Georgia1

Study leadership

  • Sandra A Mitchell, C.R.N.P. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Children aged 5 to 17 years old (Project 1) or children aged 8 to 17 years old (Project 2)
Clinical diagnosis of cGVHD following allogeneic stem cell transplant
Currently receiving systemic treatment for GVHD (including phototherapies), or has had systemic therapy for GVHD tapered to discontinuation within the past 12 months
No evidence of malignant disease relapse including molecular relapse and minimal residual disease. Patients with mixed chimerism are eligible to participate
Must have an eligible caregiver proxy who is willing to participate in the study.
Parent or guardian ability and willingness to sign a written informed consent document
Must be able to comprehend and speak the English language
Participants may enroll in both Project 1 and Project 2 of the study. Participation in Project 1 is not required in order to be eligible to participate in Project 2.
Must be willing and able to provide informed consent
Must be able to comprehend and speak the English language

What this trial measures

  • Feasability3 years

    To develop a psychometrically valid Pediatric cGVHD Symptom Scale (PCSS) and a companion parent-proxy measure as counterparts to the Lee cGVHD Symptom Scale.