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NCT Number: NCT07804875

Symptom Trajectory Approaches to Research

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.

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Key information

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Los Angeles, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

- Children:

  • 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

Inclusion criteria

- Caregivers:

  • Aged >18
  • Caregiver of a child diagnosed with advanced cancer
  • English or Spanish literate
  • Identified as being substantially involved in caring for the child

Exclusion criteria

  • Any condition that would prevent participants from completing surveys

Treatment and study plan

Health Surveys

Other

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

Primary outcomes

  1. Change in Pediatric Patient-Reported Outcome Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE)

    Time frame: Baseline, bi-weekly for 4 months

    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

  1. Change in PROMIS Pediatric Global Health 7

    Time frame: Baseline, bi-weekly for 4 months

    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.

  2. Change in PROMIS Pediatric Mobility - Short Form 7a

    Time frame: Baseline, bi-weekly for 4 months

    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.

  3. Change in PROMIS Pediatric Physical Stress Experiences - Short Form 8a

    Time frame: Baseline, bi-weekly for 4 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sabrina Cordon-Royer

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Children's Hospital Los Angeles
  • Columbia University
  • National Cancer Institute (NCI)
  • Nationwide Children's Hospital
  • New York Presbyterian Hospital
  • OHSU Doernbecher Children's Hospital
  • Oregon Health and Science University

Registry information

Official study title

Defining Symptom Trajectories to Inform Risk-Stratified Approaches to Symptom Management in Children With Advanced Cancer

Acronym: STAR

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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