TumorNCT03229837
Validation Study of Pediatric Patient-Reported Outcomes
An observational study of Tumor and Malignancy, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
Survivors of childhood cancer often suffer treatment-related toxicities, including chronic health conditions, high symptom burden and emotional distress, and decremented functional status and quality of life. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Tumor, Malignancy
- How many people
- 303 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants will be recruited from a cohort of diverse childhood cancer survivors who were treatment at St. Jude and their parents/legal guardians.
Who may be able to join
- St. Jude childhood cancer survivors who have consented to SJLIFE;
- Age at assessment: 8-18.9 years at T1 (toward 20.9 years at T3);
- 2 years off therapy and > 5 years since diagnosis; and
- Agrees to complete three annual assessments during routinely scheduled ACT clinic appointments.
- Parent/legal guardian of St. Jude childhood cancer survivor aged 8-18.9 who is eligible to participate and has agreed to do so;
- Participant is not developmentally delayed, intellectually disabled or non-communicative; and
- Participant speaks and understands the English language.
Who cannot join
- Cancer-related or unrelated (e.g., genetic disorders) neurocognitive injuries that requires parents/proxies to complete the survey [e.g. intelligence quotient (IQ) <70];
- Inability to read and speak English; or
- Parent doesn't agree to participate in the parent part of the study.
- Developmentally delayed, intellectually disabled or non-communicative;
- Unable to speak or understand the English language; and
- Child doesn't agree to participate in child part of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: Pediatric Patient-Reported Outcomes (PEPR) for Childhood Cancer Survivors: Clinical Validity Study
Survivors of childhood cancer often suffer treatment-related toxicities, including chronic health conditions, high symptom burden and emotional distress, and decremented functional status and quality of life. Although some patient-reported outcome (PRO) tools are available for survivors of childhood cancer younger than 18 years old, very few studies have been designed to evaluate longitudinal measurement properties of these PRO tools. In this study the investigators propose to recruit participants from a cohort of diverse childhood cancer survivors who were treated at St. Jude Children's Research Hospital (St. Jude) to improve assessment tools for PROs and health-related quality of life (HRQOL).
The purpose of this study is to measure the link between Patient Reported Outcome Measurement Information System (PROMIS) and clinical assessments of childhood cancer survivors over time. PROMIS is a questionnaire that measures patient-reported outcomes in adults and children.
Read more
The study plans to enroll 300 children. Surveys will be completed by the children and their parents/legal guardians (a total of 600 surveys).
PRIMARY OBJECTIVES:
- To evaluate the longitudinal construct validity of the PROMIS Pediatric measures for childhood cancer survivors by testing the association of change in PROMIS PRO scores and the change in health status measured by objective clinical assessment. Age at baseline and sex will be included in the analysis.
- To establish clinically meaningful classifications of the PROMIS Pediatric measures for childhood cancer survivors by referring PROMIS PRO scores to health status measured by clinical assessment. Age at baseline and sex will be included in the analysis.
- To estimate the minimally important differences (MIDs) of the PROMIS Pediatric measures by referring to the change of health status evaluated by anchor-based anchors and patient-based anchors for childhood cancer survivors. Age at baseline and sex will be included in the analysis.
Read the detailed description
A longitudinal framework was designed to collect data from childhood cancer survivors (8-18.9 years of age) and parents of participating cancer survivors (i.e., dyads) when they visit the After Completion of Therapy (ACT) clinic at St. Jude in three consecutive years (approximately 1 year apart; T1, T2, and T3).
Participants will complete pediatric patient-reported outcomes (PRO) survey/questionnaires, a neurocognitive assessment and physical performance evaluation will be completed, and parental surveys will be conducted. In addition, any data collected as part of the SJLIFE protocol may also be used as part of this study.
- The Pediatric PRO survey/questionnaires collection information on PROs. They include questions about general health, pain interference, fatigue, psychological stress experiences, stigma, sleep disturbance, sleep-related impairment, positive affect, meaning and purpose, depressive symptoms, anxiety, and physical function-mobility. Each cancer survivor will complete these during annual follow-up visits at three time points: years 1, 2 and 3. This process takes approximately 30-40 minutes.
- Neurocognitive evaluation is done by tests given by a licensed or certified psychological examiner to evaluate how the participant processes information. The tests evaluate how problems are solved, how well information is remembered, how well the participant pays attention, how quickly they understand information, and their assessment of quality of life. The tests are commonly used standardized tests that take about 2 hours to complete.
- Physical performance evaluation will measure heart and lung fitness, flexibility, mobility, muscle strength, endurance, balance and physical mobility. Testing takes about 2 hours to complete and includes six-minute walk test, walking speed test, muscle strength and flexibility, and balance.
- The parental survey is a parent-report form (PRF) to be completed by parents/legal guardians of participants. Information collected on the PRF includes demographic information, parental quality of life, social support, family dynamics, parenting behaviors, and the child's health care utilization data. The child and parent data will be compared. Parental questionnaires will be completed at one time point, year 1, 2, or 3, and will take approximately 40 minutes to complete.
- Conditions
- Tumor, Malignancy
- Keywords
- Construct validity, Minimally important differences, Patient-reported outcomes, Pediatric cancer survivors, PROMIS pediatric measures
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of PROs
The change of patient-reported outcome (PRO) between time points will be calculated.
Measured: From baseline through 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start1 Aug 2017
- Primary completion22 Apr 2023
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe 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
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Children's Hospital of Philadelphia
- Responsible party
- Sponsor
- Investigators
- I-Chan Huang, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229837
- Sponsor's protocol ID
- PEPR II
- Other IDs
- U19AR069525
- Status last verified
- Feb 2026
- First submitted
- 7 Jul 2017
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Patient-Reported Outcomes (PEPR) for Childhood Cancer Survivors: Clinical Validity Study
- ClinicalTrials.gov ID
- NCT03229837
- Acronym / sponsor ID
- PEPR II
- Conditions
- Tumor, Malignancy
- Keywords
- Construct validity, Minimally important differences, Patient-reported outcomes, Pediatric cancer survivors, PROMIS pediatric measures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Children's Hospital of Philadelphia
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 22 Apr 2023 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 26 Jul 2017 (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.
Survivors of childhood cancer often suffer treatment-related toxicities, including chronic health conditions, high symptom burden and emotional distress, and decremented functional status and quality of life. Although some patient-reported outcome (PRO) tools are available for survivors of childhood cancer younger than 18 years old, very few studies have been designed to evaluate longitudinal measurement properties of these PRO tools. In this study the investigators propose to recruit participants from a cohort of diverse childhood cancer survivors who were treated at St. Jude Children's Research Hospital (St. Jude) to improve assessment tools for PROs and health-related quality of life (HRQOL).
The purpose of this study is to measure the link between Patient Reported Outcome Measurement Information System (PROMIS) and clinical assessments of childhood cancer survivors over time. PROMIS is a questionnaire that measures patient-reported outcomes in adults and children.
The study plans to enroll 300 children. Surveys will be completed by the children and their parents/legal guardians (a total of 600 surveys).
PRIMARY OBJECTIVES:
- To evaluate the longitudinal construct validity of the PROMIS Pediatric measures for childhood cancer survivors by testing the association of change in PROMIS PRO scores and the change in health status measured by objective clinical assessment. Age at baseline and sex will be included in the analysis.
- To establish clinically meaningful classifications of the PROMIS Pediatric measures for childhood cancer survivors by referring PROMIS PRO scores to health status measured by clinical assessment. Age at baseline and sex will be included in the analysis.
- To estimate the minimally important differences (MIDs) of the PROMIS Pediatric measures by referring to the change of health status evaluated by anchor-based anchors and patient-based anchors for childhood cancer survivors. Age at baseline and sex will be included in the analysis.
Detailed description
A longitudinal framework was designed to collect data from childhood cancer survivors (8-18.9 years of age) and parents of participating cancer survivors (i.e., dyads) when they visit the After Completion of Therapy (ACT) clinic at St. Jude in three consecutive years (approximately 1 year apart; T1, T2, and T3).
Participants will complete pediatric patient-reported outcomes (PRO) survey/questionnaires, a neurocognitive assessment and physical performance evaluation will be completed, and parental surveys will be conducted. In addition, any data collected as part of the SJLIFE protocol may also be used as part of this study.
- The Pediatric PRO survey/questionnaires collection information on PROs. They include questions about general health, pain interference, fatigue, psychological stress experiences, stigma, sleep disturbance, sleep-related impairment, positive affect, meaning and purpose, depressive symptoms, anxiety, and physical function-mobility. Each cancer survivor will complete these during annual follow-up visits at three time points: years 1, 2 and 3. This process takes approximately 30-40 minutes.
- Neurocognitive evaluation is done by tests given by a licensed or certified psychological examiner to evaluate how the participant processes information. The tests evaluate how problems are solved, how well information is remembered, how well the participant pays attention, how quickly they understand information, and their assessment of quality of life. The tests are commonly used standardized tests that take about 2 hours to complete.
- Physical performance evaluation will measure heart and lung fitness, flexibility, mobility, muscle strength, endurance, balance and physical mobility. Testing takes about 2 hours to complete and includes six-minute walk test, walking speed test, muscle strength and flexibility, and balance.
- The parental survey is a parent-report form (PRF) to be completed by parents/legal guardians of participants. Information collected on the PRF includes demographic information, parental quality of life, social support, family dynamics, parenting behaviors, and the child's health care utilization data. The child and parent data will be compared. Parental questionnaires will be completed at one time point, year 1, 2, or 3, and will take approximately 40 minutes to complete.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants will be recruited from a cohort of diverse childhood cancer survivors who were treatment at St. Jude and their parents/legal guardians.
Key inclusion criteria (7 listed)
- St. Jude childhood cancer survivors who have consented to SJLIFE;
- Age at assessment: 8-18.9 years at T1 (toward 20.9 years at T3);
- 2 years off therapy and > 5 years since diagnosis; and
- Agrees to complete three annual assessments during routinely scheduled ACT clinic appointments.
- Parent/legal guardian of St. Jude childhood cancer survivor aged 8-18.9 who is eligible to participate and has agreed to do so;
Key exclusion criteria (6 listed)
- Cancer-related or unrelated (e.g., genetic disorders) neurocognitive injuries that requires parents/proxies to complete the survey [e.g. intelligence quotient (IQ) <70];
- Inability to read and speak English; or
- Parent doesn't agree to participate in the parent part of the study.
- Developmentally delayed, intellectually disabled or non-communicative;
- Unable to speak or understand the English language; and
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
Change of PROs
Time frame: From baseline through 3 years
The change of patient-reported outcome (PRO) between time points will be calculated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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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.
I-Chan Huang, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tumor and Malignancy, run by St. Jude Children's Research Hospital at 1 site in United States.
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 7 inclusion and 6 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: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of PROs (time frame: From baseline through 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2026.