Clinical trial · Observational
Symptom Trajectory Approaches to Research
Defining Symptom Trajectories to Inform Risk-Stratified Approaches to Symptom Management in Children With Advanced Cancer
NCT07804875CI-TRIAL-00125925STARnot yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Cancer Treatment | — | UNRESOLVED | — |
| Metastatic Disease | — | UNRESOLVED | — |
| Progressive Disease | — | UNRESOLVED | — |
| Recurrent Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Health surveys | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Children with advanced cancer
- interventionNames
- Other: Health surveys
Primary outcomes (1)
- measure
- Change in Pediatric Patient-Reported Outcome Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE)
- timeFrame
- Baseline, bi-weekly for 4 months
- description
- 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 (3)
- measure
- Change in PROMIS Pediatric Global Health 7
- timeFrame
- Baseline, bi-weekly for 4 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.