An observational study in Advanced Cancer, Metastatic Disease and Cancer Treatment, sponsored by University of Wisconsin, Madison. Not yet recruiting at 5 sites in United States. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by University of Wisconsin, Madison · Observational
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:
Participants will answer simple surveys about their health.
The use of conventional and novel therapeutics to treat children with advanced cancer leads to burdensome physical and psychological symptoms. Advanced cancer is metastatic upon initial diagnosis, relapsed, progressed, or refractory to treatment, resulting in an uncertain and prolonged disease course. Symptom burden and associated suffering are amplified for these children due to disease burden, intense therapy, and often lengthy treatment. Symptom patterns (trajectories) have been identified in children diagnosed with early-stage cancer, but research characterizing symptom patterns over time in the understudied patient population of children with advanced cancer is sparse.
Potential participants will be identified through the pediatric hematology/oncology research team and/or clinicians.
Inclusion Criteria - Children:
Inclusion Criteria - Caregivers:
Exclusion Criteria:
Other: Health surveys
Participants will complete several surveys about their quality of life and health.
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.
Time frame: Baseline, bi-weekly for 4 months
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.
Time frame: Baseline, bi-weekly for 4 months
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.
Time frame: Baseline, bi-weekly for 4 months
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.
Time frame: Baseline, bi-weekly for 4 months
Plan to share: Yes
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University of Wisconsin, Madison