Symptom Trajectory Approaches to Research (STAR)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Progressive Disease; Advanced Cancer; Metastatic Disease; Recurrent Cancer; Cancer Treatment
• Intervention / Treatment: Other: Health surveys

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 228

Contacts and Locations

• Study Contact: Name: Sabrina Cordon-Royer; Email: cordonroyer@wisc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles
  • New York
    • New York, New York, United States, 10032
      • New York -Presbyterian Morgan Stanley Children's Hospital
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Doernbecher Children's Hospital
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • American Family Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Potential participants will be identified through the pediatric hematology/oncology research team and/or clinicians.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children with advanced cancer	Other: Health surveys; Participants will complete several surveys about their quality of life and health.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, bi-weekly for 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline, bi-weekly for 4 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Cancer Institute (NCI); Columbia University; Oregon Health and Science University; Nationwide Children's Hospital; New York Presbyterian Hospital; Children's Hospital Los Angeles; OHSU Doernbecher Children's Hospital
• Investigators: Principal Investigator: Kathleen (Kitty) Montgomery, PhD, RN, PCNS-BC, University of Wisconsin, Madison; Principal Investigator: Kristine Kwekkeboom, PhD, RN, FAAN, University of Wisconsin, Madison; Principal Investigator: Roger Brown, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): May 31, 2031
• Study Completion (Estimated): May 31, 2031

Study Registration Dates

• First Submitted: September 1, 2026
• First Submitted That Met QC Criteria: September 1, 2026
• First Posted (Actual): September 4, 2026

Study Record Updates

• Last Update Posted (Actual): September 4, 2026
• Last Update Submitted That Met QC Criteria: September 1, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Undergoing cancer treatment; undergoing cancer comfort care
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease Attributes; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Recurrence; Disease Progression; Neoplasm Metastasis; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires; Health Surveys
• Other Study ID Numbers: 2026-0259; UWMSN | Nursing | Administrati (Other Identifier: UW Madison); 1R01CA307143 (U.S. NIH Grant/Contract); Protocol Version 2/11/26 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No