NCT03593525

SPARK Symptom Screening and Feedback to Providers

Completed NA Results posted Last updated 8 August 2025

What this trial tests

NA trial testing SPARK in Pediatric Oncology in 345 participants. Completed in 17 September 2023.

Timeline

1 September 2018

Primary endpoint
16 September 2023

17 September 2023

Quick facts

Lead sponsor	The Hospital for Sick Children
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	345
Start date	1 September 2018
Primary completion	16 September 2023
Estimated completion	17 September 2023
Sites	1 location across Canada

Drugs / interventions tested

• SPARK

Conditions studied

• Pediatric Oncology — all drugs for Pediatric Oncology →
• Quality of Life — all drugs for Quality of Life →

Sponsor

The Hospital for Sick Children

Who can join

Adults 8 to 18, any sex, with Pediatric Oncology or Quality of Life. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

SSPedi (Symptom Screening in Pediatrics) Total Scores Primary · Measure will be completed by all participants at baseline (day 1) and day 5±1 day.

The primary outcome will be the self-reported total SSPedi score on day 5. The total SSPedi score is a validated measure that reflects the total burden of bothersome symptoms experienced. The total score is the sum of each of the 15 items' Likert scores which range from 0 (not at all bothered) to 4 (extremely bothered) to yield a total score that ranges from 0 (no bothersome symptoms) to 60 (worst bothersome symptoms).

SSPedi Baseline Total Scores

Group	Value	95% CI
SPARK Intervention	13.2	± 8.0
Standard of Care Arm	13.1	± 8.2

SSPedi Day 5 Total Scores

Group	Value	95% CI
SPARK Intervention	10.2	± 7.4
Standard of Care Arm	12.7	± 8.3

Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom Secondary · Measure will be completed by all participants on baseline (day 1) and day 5±1 day.

The subscale SSPedi score is a validated measure that reflects the burden of a bothersome symptom experienced. Each of the 15 symptoms assessed by the SSPedi questionnaire will serve as secondary outcomes. The subscale uses a Likert score that ranges from 0 (not at all bothered) to 4 (extremely bothered). The reported values represent the number of participants who had symptoms rated as severely bothersome, defined as a score of 3 or 4 on the subscale. Higher reported scores indicate a higher number of participants that reported the level of bother for that symptom as a 3 or a 4.

SSPedi: Feeling sad or dissapointed baseline

Group	Value	95% CI
SPARK Intervention	18
Standard of Care Arm	11

SSPedi: Feeling scared or worried baseline

Group	Value	95% CI
SPARK Intervention	18
Standard of Care Arm	17

SSPedi: Feeling cranky or angry baseline

Group	Value	95% CI
SPARK Intervention	10
Standard of Care Arm	11

SSPedi: Problems thinking or remembering things baseline

Group	Value	95% CI
SPARK Intervention	11
Standard of Care Arm	8

SSPedi: Changes in how your body or face look baseline

Group	Value	95% CI
SPARK Intervention	16
Standard of Care Arm	15

SSPedi: Feeling tired baseline

Group	Value	95% CI
SPARK Intervention	55
Standard of Care Arm	54

SSPedi: Mouth sores baseline

Group	Value	95% CI
SPARK Intervention	12
Standard of Care Arm	9

SSPedi: Headache baseline

Group	Value	95% CI
SPARK Intervention	10
Standard of Care Arm	11

Faces Pain Scale-Revised Secondary · Measure will be completed by all participants on day 1 (baseline) and day 5±1 day

Self-reported pain will be assessed using the Faces Pain Scale-Revised which consists of a series of horizontal faces that depict a neutral facial expression of no pain on the left and worst pain on the right. It has 6 faces and may be scored on a 0 to 10 scale in which higher numbers denote more pain.

Face Pain Scale-Revised score baseline

Group	Value	95% CI
SPARK Intervention	1.6	± 1.9
Standard of Care Arm	1.4	± 1.9

Face Pain Scale-Revised score day 5

Group	Value	95% CI
SPARK Intervention	1.7	± 2.1
Standard of Care Arm	1.4	± 1.9

PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module Secondary · Measure will be completed by all participants on day 1 (baseline) and day 5±1 day

Self-reported QoL will be measured using the PedsQL 3.0 Acute Cancer Module. This measure is a multidimensional instrument that is reliable and valid in children with cancer. It assesses pain and hurt, nausea, procedural anxiety, treatment anxiety, worry, cognitive problems, perceived physical appearance and communication. The self-report 7-day recall version will be used. The problems are rated from 0; never a problem to 4 if it is almost always a problem. They produce 8 domain scores ranging from 0 to 100, with higher scores denote better health.

PedsQL 3.0 Pain and hurt baseline

Group	Value	95% CI
SPARK Intervention	66.5	± 26.5
Standard of Care Arm	68.3	± 26.5

PedsQL 3.0 Nausea baseline

Group	Value	95% CI
SPARK Intervention	69.2	± 22.2
Standard of Care Arm	71.6	± 20.7

PedsQL 3.0 Procedural Anxiety baseline

Group	Value	95% CI
SPARK Intervention	65.5	± 29.4
Standard of Care Arm	63.8	± 32.7

PedsQL 3.0 Treatment Anxiety baseline

Group	Value	95% CI
SPARK Intervention	77.0	± 25.7
Standard of Care Arm	78.6	± 25.8

PedsQL 3.0 Worry baseline

Group	Value	95% CI
SPARK Intervention	62.4	± 26.9
Standard of Care Arm	62.9	± 27.0

PedsQL 3.0 Cognitive problems baseline

Group	Value	95% CI
SPARK Intervention	69.7	± 21.3
Standard of Care Arm	70.1	± 21.3

PedsQL 3.0 Perceived physical appearance baseline

Group	Value	95% CI
SPARK Intervention	75.3	± 24.4
Standard of Care Arm	75.4	± 26.2

PedsQL 3.0 Communication baseline

Group	Value	95% CI
SPARK Intervention	72.9	± 22.7
Standard of Care Arm	75.1	± 23.1

Sponsor's own description

Supportive care Prioritization, Assessment and Recommendations for Kids (SPARK) is a web-based application which builds upon the Symptom Screening in Pediatrics Tool (SSPedi) and consists of two components: (1) a symptom screening component centered on SSPedi; and (2) a supportive care clinical practice guideline (CPG) component. This proposal is a randomized controlled trial that compares daily completion of SSPedi via SPARK for 5 days with symptom feedback to healthcare providers compared with standard of care

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Symptom Screening for Hospitalized Pediatric Patients With Cancer: A Randomized Clinical Trial.
   Dupuis LL, Johnston DL, Dix D, McKillop S, et al · · 2025 · cited 17× · PMID 39535812 · DOI 10.1001/jamapediatrics.2024.4727