Symptom Trajectory Approaches to Research

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-18
SponsorUniversity of Wisconsin, Madison

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Health surveys

    Other intervention

    Participants will complete several surveys about their quality of life and health.

Treatment groups

228 Participants
are divided into 1 treatment group
Group A: Children with advanced cancer1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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: