Developing a symptom scale for children with chronic graft-versus-host disease
Development and Psychometric Testing of a Pediatric Chronic Graft- Versus-Host Disease (GVHD) Symptom Scale (PCSS)
This study is trying to create a new symptom scale for kids with chronic graft-versus-host disease to better understand their experiences and improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 420 (estimated) |
| Ages | 5 Years to 99 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 17 sites (Phoenix, Arizona and 16 other locations) |
| Trial ID | NCT04044365 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a Pediatric cGVHD Symptom Scale specifically designed for children and adolescents suffering from chronic graft-versus-host disease (cGVHD) following hematopoietic stem cell transplantation. The study will involve children aged 5 to 17 years who are currently receiving or have recently received treatment for cGVHD. It will also include a companion questionnaire for caregivers to capture the symptom experiences of younger children who may not be able to articulate their symptoms. The goal is to improve symptom measurement and enhance the quality of life for affected children and adolescents.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 5 to 17 years who have a clinical diagnosis of cGVHD and are currently receiving or have recently tapered off systemic treatment for the condition.
Not a fit: Patients who are not experiencing cGVHD or those who are not receiving treatment for it may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better symptom management and improved quality of life for children living with cGVHD.
How similar studies have performed: While there have been successful studies in adult populations using similar symptom scales, this approach for pediatric patients is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: Pediatric Participant Inclusion Criteria: * 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. Caregiver Proxy Inclusion Criteria * Adult (\>=18 years old) caregiver of a child participating in Project 1 or Project 2; OR Adult (\>=18 years old) caregiver of a child aged 5 to 7 years old who meets all Pediatric Participant Inclusion Criteria except Project 2 criteria noted above in the section Pediatric Participant Inclusion Criteria * Must be willing and able to provide informed consent * Must be able to comprehend and speak the English language EXCLUSOIN CRITERIA: Children may be excluded from this study if in the judgment of the Principal or Associate Investigator, the child is too ill, or the child s cognitive ability would compromise their ability to participate in study related procedures.
Where this trial is running
Phoenix, Arizona and 16 other locations
- Phoenix Children's Hospital — Phoenix, Arizona, United States (Recruiting)
- City of Hope — Duarte, California, United States (Not_yet_recruiting)
- Children's Hospital Colorado (CHCO) — Aurora, Colorado, United States (Active_not_recruiting)
- Children s National Medical Center (CNMC) — Washington D.C., District of Columbia, United States (Active_not_recruiting)
- Children's Healthcare of Atlanta - Egleston Hospital — Atlanta, Georgia, United States (Active_not_recruiting)
- Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Active_not_recruiting)
- Johns Hopkins Hospital (JHH) — Baltimore, Maryland, United States (Active_not_recruiting)
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Active_not_recruiting)
- University of Minnesota — Minneapolis, Minnesota, United States (Active_not_recruiting)
- University of Pittsburgh - Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
- St. Jude Children s Research Hospital — Memphis, Tennessee, United States (Active_not_recruiting)
- Texas Children's Hospital (TCH)-Baylor — Houston, Texas, United States (Active_not_recruiting)
- The University of Texas MD Anderson Cancer Institute — Houston, Texas, United States (Active_not_recruiting)
- Fred Hutchinson Cancer Center (FHCC) — Seattle, Washington, United States (Active_not_recruiting)
- Children's Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
- Hospital for Sick Children (SickKids) — Toronto, Canada (Active_not_recruiting)
- Children's & Women's Health Centre of British Columbia (CWHC of BC) — Vancouver BC, Canada (Active_not_recruiting)
Study contacts
- Principal investigator: Lori S Wiener, Ph.D. — National Cancer Institute (NCI)
- Study coordinator: Lori S Wiener, Ph.D.
- Email: wienerl@mail.nih.gov
- Phone: (240) 760-6419
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.