Symptom Trajectory Approaches to Research

NCT07804875 | Not Yet Recruiting

• 4 other identifiers: 2026-02591R01CA307143Protocol Version 2/11/26UWMSN | Nursing | Administrati
• Study Type: observational
• Target: 228
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Advanced Cancer; Metastatic Disease; Cancer Treatment; Progressive Disease; Recurrent Cancer

Keywords

Undergoing cancer treatment; undergoing cancer comfort care

Outcome Measures

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.

  Baseline, bi-weekly for 4 months

Secondary Outcomes (3)

• Change in PROMIS Pediatric Global Health 7

  Baseline, bi-weekly for 4 months

• Change in PROMIS Pediatric Mobility - Short Form 7a

  Baseline, bi-weekly for 4 months

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

  Baseline, bi-weekly for 4 months

Study Arms (1)

Children with advanced cancer

Other: Health surveys

Interventions

Health surveys OTHER

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

Children with advanced cancer

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Any condition that would prevent participants from completing surveys

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• 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

Study Sites (5)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

New York -Presbyterian Morgan Stanley Children's Hospital

New York, New York, 10032, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

OHSU Doernbecher Children's Hospital

Portland, Oregon, 97239, United States

Location

American Family Children's Hospital

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Disease Progression; Recurrence

Interventions

Health Surveys

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabrina Cordon-Royer

CONTACT

cordonroyer@wisc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 4, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): May 31, 2031
• Study Completion (Estimated): May 31, 2031
• Last Updated: September 4, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

US (5)