Feasibility of a randomized controlled trial of symptom screening and feedback to healthcare providers compared with standard of care using the SPARK platform
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Supportive care Prioritization, Assessment and Recommendations for Kids (SPARK) is a web-based application that enables symptom screening and access to clinical practice guidelines for symptom management. Objective was to determine the feasibility of a randomized trial of daily symptom screening for 5 days among children receiving cancer treatments.
We included English-speaking pediatric cancer and hematopoietic stem cell transplantation (HSCT) patients who were 8–18 years of age at enrollment and who were expected to be in the hospital or in clinic daily for five consecutive days. We randomized children to either undergo daily symptom screening with symptom reports provided to the healthcare team using the SPARK vs. standard of care. The primary endpoint was feasibility, defined as being able to enroll at least 30 participants within 1 year, and among those randomized to intervention, at least 75% completing symptom screening on at least 60% of on-study days.
From July 2018 to November 2018, we enrolled and randomized 30 participants. The median age at enrollment was 12.5 (range 8–18) years. Among the intervention group, the median number of days Symptom Screening in Pediatrics Tool (SSPedi) was completed at least once was 5 (range 4 to 5), with one participant missing 1 day of symptom screening. Among all participants, baseline and day 5 SSPedi scores were obtained in 29/30 participants.
A randomized trial of the SPARK with daily symptom screening for 5 days was feasible. It is now appropriate to proceed toward a definitive multi-center trial to test the efficacy of SPARK to improve symptom control.
KeywordsChildren Feasibility Supportive care Symptom screening
All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by Sadie Cook, Emily Vettese, and Lillian Sung. The first draft of the manuscript was written by Sadie Cook, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
This research is funded by Canadian Institutes of Health Research (CIHR) catalyst grant (funding number 155446). LS is supported by the Canada Research Chair in Pediatric Oncology Supportive Care.
Compliance with ethical standards
Informed consent was obtained from all individual participants included in the study. The authors have declared no conflicts of interest.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the Research Ethics Board at SickKids, and are registered with clinicaltrial.gov (NCT03495518), and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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