Three Times Weekly Symptom Screening for Children With Cancer

NCT04275102 | Not Yet Recruiting

• 1 other identifier: REB# 1000063548
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the feasibility of three times weekly symptom reporting by children using the SPARK platform for 8 weeks. SPARK is a web-based application that promotes symptom screening for children receiving cancer therapies and enables access to clinical practice guidelines for symptom management. Newly diagnosed and relapsed patients with cancer will be enrolled. Children and/or their guardian will be prompted to complete symptom screening three times weekly via SPARK with corresponding feedback sent to their healthcare providers with each completed assessment. Symptom reports will contain links to clinical practice guidelines for symptom management. Active intervention will last for 8 weeks starting from the date of enrollment.

Conditions

Cancer; Relapsed Cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility of three times weekly symptom reporting by children using the SPARK platform for 8 weeks.

  The primary endpoint is feasibility, defined as at least 75% achieving compliance with at least 60% of symptom evaluations among guardian and self-report populations.

  8 weeks

Secondary Outcomes (7)

• Symptom burden as measured by the total SSPedi score Total SSPedi symptom scores

  Baseline and weeks 4, and 8

• QoL will be measured using the PedsQL 3.0 Acute Cancer Module

  Baseline and weeks 4, and 8

• Symptom documentation

  Baseline and weeks 4, and 8

• Number of Patients' Emergency Department Visits, Unplanned Clinic Visits and Hospitalizations over the 8-week intervention

  Baseline and weeks 4, and 8

• Fatigue

  Baseline and weeks 4, and 8

Study Arms (1)

Three times weekly symptom screening

EXPERIMENTAL

Three times weekly symptom reporting by guardians and children using the SPARK platform for 8 weeks

Other: SPARK

Interventions

SPARK OTHER

Prompt to complete symptom screening three times weekly via SPARK with corresponding feedback sent to healthcare providers with each completed assessment.

Three times weekly symptom screening

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• cancer diagnosis
• years of age at enrollment
• Child has received or a plan for any chemotherapy, radiotherapy or surgery
• Understands English, French or Spanish

You may not qualify if:

• Cognitive disability
• Visual impairment (cannot see SPARK even with corrective lens)

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

MeSH Terms

Conditions

Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lillian Sung, MD, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Lillian Sung

CONTACT

4168135287; lillian.sung@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: February 19, 2020
• Study Start: August 1, 2025
• Primary Completion: November 29, 2025
• Study Completion: November 29, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)