N/A
N=445
Symptom Screening Linked to Care Pathways
Pediatric Cancer · Quality of Life
Bottom Line
View on ClinicalTrials.gov: NCT04614662 ↗Enrolled (actual)
445
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Symptom Screening in Pediatrics Tool (SSPedi) Total Score — 7.9; 11.4 Score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SPARK Symptom Screening Linked to Feedback to Providers (Behavioral)
- Age
- Pediatric, Adult · 8+ yrs
- Sex
- All
- Sponsor
- The Hospital for Sick Children
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Symptom Screening in Pediatrics Tool (SSPedi) Total Score |
7.9; 11.4 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Bank v2.0 - Fatigue |
54.6; 53.9 | — |
| SECONDARY PedsQL 3.0 Acute Cancer Module |
68.8; 69.8; 69.2; 73.9; 62.8; 66.4 | — |
| SECONDARY Documentation of Symptoms |
28; 16; 40; 26; 9; 7 | — |
| SECONDARY Provision of Interventions for Symptoms (Independent of Symptom Documentation) |
52; 82; 54; 96; 48; 67 | — |
| SECONDARY Number of Emergency Department Visits and Unplanned Clinic Visits and Hospitalizations |
1.82; 1.12 | — |
Summary
Most children with cancer survive because they are given intensive treatments, but unfortunately, these treatments are associated with distressing symptoms. To address this problem, we developed the Symptom Screening in Pediatrics Tool (SSPedi) so that children receiving cancer treatments can communicate their bothersome symptoms, and Supportive care Prioritization, Assessment and Recommendations for Kids (SPARK), a web-based application that links identified symptoms to supportive care guidelines for symptom management. To establish that these tools improve the lives of children newly diagnosed with cancer, we will conduct a trial that randomizes 20 pediatric cancer institutions and measures the impact of three times weekly symptom screening, symptom feedback to healthcare providers and the development of care pathways for symptom management to improve total symptom burden, fatigue and quality of life.
Eligibility Criteria
Inclusion Criteria
- 8-18 years of age at enrollment
- English or Spanish-speaking
- Any newly diagnosed cancer
- Have a plan for any chemotherapy, radiotherapy or surgery
- Enroll within 28 days after treatment initiation
Exclusion Criteria
- Cognitive disability (attending minimum second grade or equivalent)
- Visual impairment (cannot see SPARK even with corrective lens)
Data sourced from ClinicalTrials.gov (NCT04614662). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.