Cancer Clinical Trial
Official title:
A Feasibility Study of Three Times Weekly Symptom Screening for Children With Cancer
Verified date | June 2022 |
Source | The Hospital for Sick Children |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 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.
Status | Completed |
Enrollment | 30 |
Est. completion date | February 8, 2022 |
Est. primary completion date | January 28, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 18 Years |
Eligibility | Inclusion Criteria: - cancer diagnosis - 8-18 years of age at enrollment - Child has received or a plan for any chemotherapy, radiotherapy or surgery - Understands English or Spanish Exclusion Criteria: - Cognitive disability - Visual impairment (cannot see SPARK even with corrective lens) |
Country | Name | City | State |
---|---|---|---|
Canada | The Hospital for Sick Children | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
The Hospital for Sick Children |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 separately. | 8 weeks | |
Secondary | 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). | Baseline and weeks 4, and 8 | |
Secondary | 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. | Baseline and weeks 4, and 8 | |
Secondary | Symptom documentation | Symptom documentation and intervention provision at each time point in which symptom assessment is performed will be abstracted from the health record. | Baseline and weeks 4, and 8 | |
Secondary | 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. | Baseline and weeks 4, and 8 | |
Secondary | Fatigue | Fatigue will be measured using PROMIS. The recall period is the last 7 days. It is reliable and valid in children 5-18 years of age with cancer | Baseline and weeks 4, and 8 |
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