Graft vs Host DiseaseNCT04044365
Pediatric cGVHD Symptom Scale
An observational study of Graft vs Host Disease, run by National Cancer Institute (NCI) at 17 sites in 2 countries.
Trial summary
Background: Some children/adolescents who have had a stem cell transplant live with chronic graft-versus-host-disease (cGVHD). cGVHD is a side effect of the transplant that can cause multiple bothersome symptoms and negatively affect a child/adolescent squality of daily life. Read more about this study
- Who is it for?
- Ages 5 to 99 years
- Conditions the study is for
- Graft vs Host Disease
- How many people
- 139 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 2 Oct 2019to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children of 5 to 17 years of age and their caregiver, who have undergone prior allogeneic stem cell transplant
Who may be able to join
- 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.
Show all 15Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States15 sites
Children's Healthcare of Atlanta - Egleston Hospital
Atlanta, Georgia, 30322
Children's Hospital Colorado (CHCO)
Aurora, Colorado, 80045
Johns Hopkins Hospital (JHH)
Baltimore, Maryland, 21287
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
City of Hope
Duarte, California, 91010
Texas Children's Hospital (TCH)-Baylor
Houston, Texas, 77030
The University of Texas MD Anderson Cancer Institute
Houston, Texas, 77030
St. Jude Children s Research Hospital
Memphis, Tennessee, 38105
Children's Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
Phoenix Children's Hospital
Phoenix, Arizona, 85016
University of Pittsburgh - Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Fred Hutchinson Cancer Center (FHCC)
Seattle, Washington, 98109
Children s National Medical Center (CNMC)
Washington D.C., District of Columbia, 20010
Canada2 sites
Hospital for Sick Children (SickKids)
Toronto
Children's & Women's Health Centre of British Columbia (CWHC of BC)
Vancouver BC
About this study
Official title: Development and Psychometric Testing of a Pediatric Chronic Graft- Versus-Host Disease (GVHD) Symptom Scale (PCSS)
Background:
Some children/adolescents who have had a stem cell transplant live with chronic graft-versus-host-disease (cGVHD). cGVHD is a side effect of the transplant that can cause multiple bothersome symptoms and negatively affect a child/adolescent squality of daily life. The questionnaires that measure thesymptoms caused by cGVHD are designed for adults. Children/adolescents may not describe their symptoms in the same way. The goal of this research is to improve the way we measure how bothersome these symptoms are for children/adolescents living with cGVHD.
Read more
Objective:
To develop a questionnaire (The Pediatric cGHVD Symptom Scale) for children/adolescents living with cGVHD to identify the symptoms they are experiencing and describe how bothersome those symptoms are to them. An additional goal is to design a parent/guardian companion questionnaire that can be used to capture the symptom experiences of very young children who may not be able to complete a questionnaire.
Eligibility:
Children/adolescents ages 5-17 who are receiving treatment for cGVHD after a stem cell transplant, and their parent/guardian..
Design:
This study consists of 2 projects.
Children/adolescents with cGVHD and their parent/guardianparticipants will be grouped by the child/adolescent s age: 5-7, 8-12, and 13-17.
In project 1, participants will complete an age-appropriate questionnaire about cGVHD symptoms. The questionnaire will ask about the child/adolescent s physical functioning and emotional well-being. The parent/guardian will out fill out a companion questionnaire online. The child/adolescent will then review their completed questionnaire during an interview with a researcher and will be asked whether the questions about their symptoms were difficult to understand. The parent/guardian and child/adolescent will then be interviewed together to further explore their responses to the questionnaires. Interviews will be done in person, by phone, and online. . Based on what is learned through these interviews, the wording of the questionnaire will be improved for better comprehension and ease of response.
In project 2, participants will complete this revised questionnairefor their age group along with some other questionnaires that ask about quality of life. Both the child/adolescent and parent/guardian will fill out the questionnaires online at three separate time points.
In both projects, children/adolescents with cGVHD and their parent/guardian participants will be grouped by the child/adolescent s age: 5-7, 8-12, and 13-17.
...
Read the detailed description
Background:
- Hematopoietic stem cell transplantation (HSCT) is a curative option for many children with cancer and certain genetic disorders. However, recipients of stem cell transplant must deal with years of disfigurement and symptoms arising from an undesirable side effect of transplant, specifically chronic graft-versus-host-disease (cGVHD).
- Children living with cGVHD often face many years of a disabling and painful chronic illness compounded by the side effects of prolonged immunosuppression, particularly long-term steroid use.
- Chronic GVHD can involve almost every organ although it most commonly affects the skin, eyes, mouth, liver, intestines, lung and the musculoskeletal system.
- There has been a large effort through the NIH cGVHD Consensus Consortium to standardize definitions, grading and response criteria for patients with cGVHD on clinical trials. Because of the absence of evidence suggesting which response criteria truly correlates with improvement, the NIH Consensus Panel has recommended following not only physical signs of chronic GVHD, but also symptoms of GVHD.
- The Lee cGVHD Symptom Score has been recognized as a core cGVHD outcome measure in the adult population, however, the instrument has not been validated for use in children/adolescents younger than 18, and many of the symptom terms used in the Lee cGVHD Symptom Scale may not be well understood by younger children.
- There is currently no available pediatric patient-reported outcome (PRO) measure of cGVHD symptom bother.
Primary Objective:
-To develop a psychometrically valid Pediatric cGVHD Symptom Scale (PCSS) and a companion caregiver-proxy measure as counterparts to the Lee cGVHD Symptom Scale.
Eligibility:
- Children 5 to 17 years of age for Project 1 or 8-17 years of age for Project 2, who have undergone prior allogeneic stem cell transplant
- Clinical diagnosis of cGVHD
- Currently receiving systemic treatment for cGVHD (including phototherapies), or has tapered systemic therapy for cGVHD 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
- Comprehend and speak English
- Caregivers of children 5-17 years of age with cGVHD enrolled as a proxies
Design:
- This multicenter non-interventional psychosocial trial will address the study aims in two projects: 1) a qualitative project using cognitive interviewing to confirm the comprehension and ease of response to the PCSS, and 2) a quantitative project to evaluate test-retest reliability, construct validity and responsiveness of the PCSS, as well as to explore concordance of symptom ratings by patients and caregiver proxies.
- In Project 1 (COMPLETE), we will conduct at least 20 cognitive interviews of patient and proxy dyads (caregiver) within each age group (5-7; 8-12; 13-17) for a sample of up to 90 pediatric transplant survivors with cGVHD to refine the symptom items and response choices to ensure that they resonate across the developmental spectrum. Cognitive interviews will evaluate the clarity and comprehension of the PCSS items, the ease and accuracy of judgement of the response choices, and any errors in understanding the response choices, and will refine the PCSS in accordance with study data, before proceeding to Project 2.
- In Project 2, we will evaluate test-retest reliability, construct validity, and responsiveness of the PCSS, in association with the NIH Global cGVHD Symptom Severity Score, the Peds QL, clinician ratings of organ specific cGVHD severity scores and cGVHD severity using the NIH criteria, in a sample of 100 pediatric transplant survivors with cGVHD reflecting two age groups (8-12 years; 13-17 years) of equal numbers and 20 caregivers of children age 5-7 who will serve as proxies. In participants ages 13-17, we will also compare responses on the PCSS with those from the Lee Scale, to determine the youngest age at which adolescent respondents can comprehend the Lee Scale.
- The overall accrual ceiling is 420, which includes pediatric and caregiver participants and accounts for inevaluable participants
- This study will include CCR investigators as well as extramural investigators at national and international study sites.
- Conditions
- Graft vs Host Disease
- Keywords
- Hematopoietic Stem Cell Transplantation (HSCT), Allogeneic Stem Cell Transplant, Phototherapies, Graft Vs Host Disease, Natural History
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1/Project 1 Child/caregiver-proxy | Children age 5-7 with cGVHD and their caregiver, n=20 child/parent dyads | |
| 2/Project 1 Child/caregiver-proxy | Children age 8-12 with cGVHD and their caregiver, n=35 child/parent pairs | |
| 3/Project 1 Child/caregiver-proxy | Children age 13-17 with cGVHD and their caregiver, n=35 child/parent pairs | |
| 4/Project 2 Child/caregiver-proxy | Children age 5-7 with cGVHD and their caregiver, n=40 child/parent pairs | |
| 5/Project 2 Child/caregiver-proxy | Children age 8-12 with cGVHD and their caregiver, n=40 child/parent pairs | |
| 6/Project 2 Child/caregiver-proxy | Children age 13-17 with cGVHD and their caregiver, n=40 child/parent pairs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasability
To develop a psychometrically valid Pediatric cGVHD Symptom Scale (PCSS) and a companion parent-proxy measure as counterparts to the Lee cGVHD Symptom Scale.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start2 Oct 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Graft vs Host DiseaseStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Sandra A Mitchell, C.R.N.P., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044365
- Sponsor's protocol ID
- 190131
- Other IDs
- 19-C-0131
- Status last verified
- 13 Oct 2026
- First submitted
- 1 Aug 2019
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request.
Publications
Mitchell SA, Hunter R, Fry A, Pavletic SZ, Widemann BC, Wiener L. Development and psychometric testing of a pediatric chronic graft-versus-host disease symptom scale: protocol for a two-phase, mixed methods study. Front Psychol. 2024 Jan 8;14:1243005. doi: 10.3389/fpsyg.2023.1243005. eCollection 2023.
PubMed 38259542
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Psychometric Testing of a Pediatric Chronic Graft- Versus-Host Disease (GVHD) Symptom Scale (PCSS)
- ClinicalTrials.gov ID
- NCT04044365
- Acronym / sponsor ID
- 190131
- Conditions
- Graft vs Host Disease
- Keywords
- Hematopoietic Stem Cell Transplantation (HSCT), Allogeneic Stem Cell Transplant, Phototherapies, Graft Vs Host Disease, Natural History
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 139 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Some children/adolescents who have had a stem cell transplant live with chronic graft-versus-host-disease (cGVHD). cGVHD is a side effect of the transplant that can cause multiple bothersome symptoms and negatively affect a child/adolescent squality of daily life. The questionnaires that measure thesymptoms caused by cGVHD are designed for adults. Children/adolescents may not describe their symptoms in the same way. The goal of this research is to improve the way we measure how bothersome these symptoms are for children/adolescents living with cGVHD.
Objective:
To develop a questionnaire (The Pediatric cGHVD Symptom Scale) for children/adolescents living with cGVHD to identify the symptoms they are experiencing and describe how bothersome those symptoms are to them. An additional goal is to design a parent/guardian companion questionnaire that can be used to capture the symptom experiences of very young children who may not be able to complete a questionnaire.
Eligibility:
Children/adolescents ages 5-17 who are receiving treatment for cGVHD after a stem cell transplant, and their parent/guardian..
Design:
This study consists of 2 projects.
Children/adolescents with cGVHD and their parent/guardianparticipants will be grouped by the child/adolescent s age: 5-7, 8-12, and 13-17.
In project 1, participants will complete an age-appropriate questionnaire about cGVHD symptoms. The questionnaire will ask about the child/adolescent s physical functioning and emotional well-being. The parent/guardian will out fill out a companion questionnaire online. The child/adolescent will then review their completed questionnaire during an interview with a researcher and will be asked whether the questions about their symptoms were difficult to understand. The parent/guardian and child/adolescent will then be interviewed together to further explore their responses to the questionnaires. Interviews will be done in person, by phone, and online. . Based on what is learned through these interviews, the wording of the questionnaire will be improved for better comprehension and ease of response.
In project 2, participants will complete this revised questionnairefor their age group along with some other questionnaires that ask about quality of life. Both the child/adolescent and parent/guardian will fill out the questionnaires online at three separate time points.
In both projects, children/adolescents with cGVHD and their parent/guardian participants will be grouped by the child/adolescent s age: 5-7, 8-12, and 13-17.
...
Detailed description
Background:
- Hematopoietic stem cell transplantation (HSCT) is a curative option for many children with cancer and certain genetic disorders. However, recipients of stem cell transplant must deal with years of disfigurement and symptoms arising from an undesirable side effect of transplant, specifically chronic graft-versus-host-disease (cGVHD).
- Children living with cGVHD often face many years of a disabling and painful chronic illness compounded by the side effects of prolonged immunosuppression, particularly long-term steroid use.
- Chronic GVHD can involve almost every organ although it most commonly affects the skin, eyes, mouth, liver, intestines, lung and the musculoskeletal system.
- There has been a large effort through the NIH cGVHD Consensus Consortium to standardize definitions, grading and response criteria for patients with cGVHD on clinical trials. Because of the absence of evidence suggesting which response criteria truly correlates with improvement, the NIH Consensus Panel has recommended following not only physical signs of chronic GVHD, but also symptoms of GVHD.
- The Lee cGVHD Symptom Score has been recognized as a core cGVHD outcome measure in the adult population, however, the instrument has not been validated for use in children/adolescents younger than 18, and many of the symptom terms used in the Lee cGVHD Symptom Scale may not be well understood by younger children.
- There is currently no available pediatric patient-reported outcome (PRO) measure of cGVHD symptom bother.
Primary Objective:
-To develop a psychometrically valid Pediatric cGVHD Symptom Scale (PCSS) and a companion caregiver-proxy measure as counterparts to the Lee cGVHD Symptom Scale.
Eligibility:
- Children 5 to 17 years of age for Project 1 or 8-17 years of age for Project 2, who have undergone prior allogeneic stem cell transplant
- Clinical diagnosis of cGVHD
- Currently receiving systemic treatment for cGVHD (including phototherapies), or has tapered systemic therapy for cGVHD 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
- Comprehend and speak English
- Caregivers of children 5-17 years of age with cGVHD enrolled as a proxies
Design:
- This multicenter non-interventional psychosocial trial will address the study aims in two projects: 1) a qualitative project using cognitive interviewing to confirm the comprehension and ease of response to the PCSS, and 2) a quantitative project to evaluate test-retest reliability, construct validity and responsiveness of the PCSS, as well as to explore concordance of symptom ratings by patients and caregiver proxies.
- In Project 1 (COMPLETE), we will conduct at least 20 cognitive interviews of patient and proxy dyads (caregiver) within each age group (5-7; 8-12; 13-17) for a sample of up to 90 pediatric transplant survivors with cGVHD to refine the symptom items and response choices to ensure that they resonate across the developmental spectrum. Cognitive interviews will evaluate the clarity and comprehension of the PCSS items, the ease and accuracy of judgement of the response choices, and any errors in understanding the response choices, and will refine the PCSS in accordance with study data, before proceeding to Project 2.
- In Project 2, we will evaluate test-retest reliability, construct validity, and responsiveness of the PCSS, in association with the NIH Global cGVHD Symptom Severity Score, the Peds QL, clinician ratings of organ specific cGVHD severity scores and cGVHD severity using the NIH criteria, in a sample of 100 pediatric transplant survivors with cGVHD reflecting two age groups (8-12 years; 13-17 years) of equal numbers and 20 caregivers of children age 5-7 who will serve as proxies. In participants ages 13-17, we will also compare responses on the PCSS with those from the Lee Scale, to determine the youngest age at which adolescent respondents can comprehend the Lee Scale.
- The overall accrual ceiling is 420, which includes pediatric and caregiver participants and accounts for inevaluable participants
- This study will include CCR investigators as well as extramural investigators at national and international study sites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1/Project 1 Child/caregiver-proxy | – | –Children age 5-7 with cGVHD and their caregiver, n=20 child/parent dyads |
| 2/Project 1 Child/caregiver-proxy | – | –Children age 8-12 with cGVHD and their caregiver, n=35 child/parent pairs |
| 3/Project 1 Child/caregiver-proxy | – | –Children age 13-17 with cGVHD and their caregiver, n=35 child/parent pairs |
| 4/Project 2 Child/caregiver-proxy | – | –Children age 5-7 with cGVHD and their caregiver, n=40 child/parent pairs |
| 5/Project 2 Child/caregiver-proxy | – | –Children age 8-12 with cGVHD and their caregiver, n=40 child/parent pairs |
| 6/Project 2 Child/caregiver-proxy | – | –Children age 13-17 with cGVHD and their caregiver, n=40 child/parent pairs |
Who may qualify
- Ages
- 5 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children of 5 to 17 years of age and their caregiver, who have undergone prior allogeneic stem cell transplant
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasability
Time frame: 3 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Derived from this study: PubMed 38259542Mitchell SA, Hunter R, Fry A, Pavletic SZ, Widemann BC, Wiener L. Development and psychometric testing of a pediatric chronic graft-versus-host disease symptom scale: protocol for a two-phase, mixed methods study. Front Psychol. 2024 Jan 8;14:1243005. doi: 10.3389/fpsyg.2023.1243005. eCollection 2023.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra A Mitchell, C.R.N.P. principal investigator
National Cancer Institute (NCI)
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graft vs Host Disease, run by National Cancer Institute (NCI) at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasability (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04044365, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.