Three Times Weekly Symptom Screening for Children With Cancer

Cancer Clinical Trial

Official title: A Feasibility Study of Three Times Weekly Symptom Screening for Children With Cancer

Status Completed

Clinical Trial 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 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.

Clinical Trial Description

Primary objective is to determine the feasibility of three times weekly symptom reporting by guardians and children using the SPARK platform for 8 weeks. Feasibility will be evaluated by compliance with symptom screening and the investigators anticipate that at least 75% can achieve compliance with at least 60% of symptom evaluations. Newly diagnosed and relapsed patients with cancer 8-18 years of age 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. Patient-reported outcomes will be obtained at baseline, and weeks 4, and 8. These outcomes will include the Symptom Screening in Pediatrics Tool (SSPedi), Fatigue will be measured using PROMIS, and the Pediatric Quality of Life Inventory (PedsQL) 3.0 Acute Cancer Module. Data from health records will be abstracted for all enrolled participants to evaluate symptom documentation and intervention provision at times symptom screening is completed as well as emergency room visits, clinic visits and hospitalizations. Analyses are descriptive. The investigators' primary outcome is feasibility, sample size justification will focus on having sufficient number of guardians and children to optimize study processes and to describe the number of completed symptom assessments. The investigators will enroll up to 20-30 children per site per cohort; it is anticipated the investigators can enroll this number over one year. The 95% confidence intervals assuming 60% compliance will be 36-81% and 41-77% for 20 and 30 participants respectively; this precision is adequate for research purposes. If it is found that the processes are not feasible, the data will be reviewed after the initial cohort and enact refined procedures to rectify the identified problems. In this case enrollment of another 20-30 children per site per cohort with the updated procedures for a total sample size of 40-60 participants per site. ;

Related Conditions & MeSH terms

• Cancer
• Relapsed Cancer

• NCT number: NCT04275102
• Study type: Interventional
• Source: The Hospital for Sick Children
• Status: Completed
• Phase: N/A
• Start date: January 24, 2020
• Completion date: February 8, 2022