About this trial
The goal of this observational study is to understand how cancer makes children feel over time. The main things the researchers hope to learn are:
* When and how often do children have different feelings or sickness; * Why do these feelings happen; and, * How these feelings change a child's overall health.
Participants will answer simple surveys about their health.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 8-18 years
Diagnosis of advanced cancer of any type made by the hematology, oncology, or cellular therapy team
Undergoing cancer treatment or comfort care
Be English or Spanish literate
Disqualifiers
Any condition that would prevent participants from completing surveys
Trial population
Potential participants will be identified through the pediatric hematology/oncology research team and/or clinicians.
Trial design
Cohort
Prospective
Treatments tested in this trial
Health surveys
Other interventionParticipants will complete several surveys about their quality of life and health.
Treatment groups
Trial outcomes
Primary outcomes
Change in Pediatric Patient-Reported Outcome Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE)
Ped-PRO-CTCAE evaluates pediatric cancer symptoms using patient or caregiver reports scored on a 0-to-3 scale across attributes like frequency, severity, and interference. 38 items are scored 0-3, where 0 = never (or equivalent) and 3 = all the time (or equivalent). Scores range from 0 to 114, with higher scores indicating worse symptoms. This score will be used to measure the trajectory of symptoms over time.
Secondary outcomes
Change in PROMIS Pediatric Global Health 7
PROMIS Pediatric Global Health 7 is a 7-item survey used to measure overall physical, mental, and social health in children and adolescents. It is scored using a 5-point Likert scale, where 1 = poor and 5 = excellent. Scores range from 7 to 35, with higher scores indicating better global health.
Change in PROMIS Pediatric Mobility - Short Form 7a
PROMIS Pediatric Mobility is a 7-item questionnaire that evaluates self-perceived physical mobility and functioning in children and adolescents. It uses a 5-point Likert scale ranging from "Without no trouble" to "Not able to do". Raw scores range from 7 to 35. Raw scores are translated into normalized T-scores with a US population-level mean of 50 and a standard deviation (SD) of 10. A T-score of 50 represents average mobility for the general population. Scores above 50 mean better-than-average mobility, while scores below 50 indicate greater impairment.
Change in PROMIS Pediatric Physical Stress Experiences - Short Form 8a
PROMIS Physical Stress Experiences is an 8-item questionnaire designed to measure physical symptoms of stress in children and adolescents. It is scored by summing the raw item responses (ranging from 8 to 40) and converting that total into a standardized T-score. The raw score maps to a standardized T-score with a mean of 50 and a standard deviation (SD) of 10 for the general population. Higher T-scores reflect a greater level of physical stress.
Sponsors and contacts
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University of Wisconsin, Madison
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Nationwide Children's Hospital
Collaborator
Oregon Health and Science University
Collaborator
Children's Hospital Los Angeles
Collaborator
New York Presbyterian Hospital
Collaborator
OHSU Doernbecher Children's Hospital
Collaborator
Columbia University
Collaborator
This trial is not recruiting at the moment. You can still explore other options: