SPARK Symptom Screening and Feedback to Providers

NCT03593525 | Completed Results

• 1 other identifier: REB: 000061139
• Study Type: interventional
• Target: 345
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pediatric Oncology; Quality of Life

Keywords

Pediatric Oncology; Randomized Control Trial; Symptom Screening; Quality of Life

Outcome Measures

Primary Outcomes (1)

• SSPedi (Symptom Screening in Pediatrics) Total Scores

  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).

  Measure will be completed by all participants at baseline (day 1) and day 5±1 day.

Secondary Outcomes (3)

• Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom

  Measure will be completed by all participants on baseline (day 1) and day 5±1 day.

• Faces Pain Scale-Revised

  Measure will be completed by all participants on day 1 (baseline) and day 5±1 day

• PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module

  Measure will be completed by all participants on day 1 (baseline) and day 5±1 day

Study Arms (2)

SPARK Intervention

EXPERIMENTAL

Participants will complete symptom screening using SPARK once daily on a study-supplied iPad. For inpatients, daily reminders to complete SSPedi will appear on the iPad. Reports will be available to the child at any time. For outpatients, clinical research associates will provide the iPad in person daily and reports may be viewed at those encounters. The intervention is daily symptom screening with provision of reports to the healthcare team. Severe symptoms will result in email alerts. More specifically, SSPedi reports will be printed daily and provided in the patient chart. On days 1 and 3, an alert will be emailed to the physician providing direct medical care if any symptom is "a lot" or "extremely" bothersome (score 3 or 4 on 0-4 scale). Reports and alerts will have links to SPARK-housed CPGs.

Other: SPARK

Standard of Care Arm

NO INTERVENTION

Participants randomized to the control arm will not complete daily symptom screening. They will complete SSPedi on days 1 and 5 to obtain the primary outcome. Health care providers will not be notified of their SSPedi scores and no symptom reports or symptom alerts will be generated.

Interventions

SPARK OTHER

see above

SPARK Intervention

Eligibility Criteria

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

You may qualify if:

• to 18 years of age
• Diagnosis of cancer or have received or about to receive HSCT
• Understand English
• Expected to be in hospital or clinic for 5 day

You may not qualify if:

• illness severity
• cognitive disability
• visual impairment

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

Lillian Sung

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• Dupuis LL, Johnston DL, Dix D, McKillop S, Cook S, Crellin-Parsons N, Kulkarni K, Patel S, Vanan ML, Gibson P, Soman D, Kuczynski S, Tomlinson GA, Sung L. Symptom Screening for Hospitalized Pediatric Patients With Cancer: A Randomized Clinical Trial. JAMA Pediatr. 2025 Jan 1;179(1):11-18. doi: 10.1001/jamapediatrics.2024.4727.

  PMID: 39535812 DERIVED

Results Point of Contact

• Title: Dr. Lillian Sung
• Organization: The Hospital for Sick Children

lillian.sung@sickkids.ca

416 813 5287

Study Officials

• Lillian Sung, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Oncologist

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: July 20, 2018
• Study Start: September 1, 2018
• Primary Completion: September 16, 2023
• Study Completion: September 17, 2023
• Last Updated: August 8, 2025
• Results First Posted: July 2, 2025

Record last verified: 2025-07

Locations

CA (1)