Three Times Weekly Symptom Screening for Children With Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-18
SponsorThe Hospital for Sick Children
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
cancer diagnosis
2-18 years of age at enrollment
Child has received or a plan for any chemotherapy, radiotherapy or surgery
Understands English, French or Spanish
Disqualifiers
Cognitive disability
Visual impairment (cannot see SPARK even with corrective lens)
Trial design
Design model
Single group
Treatments tested in this trial
SPARK
Other interventionPrompt to complete symptom screening three times weekly via SPARK with corresponding feedback sent to healthcare providers with each completed assessment.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Three times weekly symptom screeningExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
8 weeksSecondary outcomes
1
Symptom burden as measured by the total SSPedi score Total SSPedi symptom scores
Total SSPedi symptom which is the sum of each of the 15 SSPedi item's Likert scores, resulting in a total score that ranges from 0 (no bothersome symptoms) to 60 (worst bothersome symptoms). The recall period is yesterday or today (SSPedi).
Time frame
Baseline and weeks 4, and 82
QoL will be measured using the PedsQL 3.0 Acute Cancer Module
Quality of life will be measured using the Pediatric Quality of Life Inventory (PedsQL) 3.0 Acute Cancer Module. The minimum value on the scale is 0 and maximum value is 100. PedsQL uses reverse scoring thus a higher score indicates a better outcome.
Time frame
Baseline and weeks 4, and 83
Symptom documentation
Symptom documentation and intervention provision at each time point in which symptom assessment is performed will be abstracted from the health record.
Time frame
Baseline and weeks 4, and 84
Number of Patients' Emergency Department Visits, Unplanned Clinic Visits and Hospitalizations over the 8-week intervention
The number of emergency department visits and unplanned clinic visits and hospitalizations over the 8-week intervention period will be abstracted from the health record.
Time frame
Baseline and weeks 4, and 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: