SPARK Symptom Screening and Feedback to Providers

NCT ID: NCT03593525

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 345 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2023-09-17

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

Detailed Description

Participants will be children with cancer or hematopoietic stem cell transplantation (HSCT) recipients who are 8-18 years of age and who can understand English, and who are expected to be in hospital or in clinic daily for 5 days. This will be a multi-center RCT in which we will randomize children to either undergo daily symptom screening for 5 days with symptom reports provided to the healthcare team or standard of care. The primary outcome will be the self-reported day 5 total SSPedi score (range 0-60; higher worse). Secondary outcomes will be the day 5 self-reported individual symptom, pain and QoL scores, and documentation of symptoms and provision of interventions for symptoms over the 5 day trial. We will enroll 345 participants over 4 years from 7 Canadian centers

Conditions

Pediatric Oncology; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

SPARK Intervention

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.

Group Type: EXPERIMENTAL

SPARK

Intervention Type: OTHER

see above

Standard of Care Arm

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SPARK

see above

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 8 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

Exclusion Criteria

• illness severity
• cognitive disability
• visual impairment

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Lillian Sung

Pediatric Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lillian Sung, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

Lillian Sung

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 39535812 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

REB: 000061139

Identifier Type: -

Identifier Source: org_study_id