Symptom Screening for Hospitalized Pediatric Patients With Cancer: A Randomized Clinical Trial.
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IMPORTANCE: Pediatric patients with cancer experience severely bothersome symptoms during treatment. It was hypothesized that symptom screening and provision of symptom reports to the health care team would reduce symptom burden in pediatric patients with cancer. OBJECTIVE: To determine if daily symptom screening and provision of symptom reports to the health care team was associated with lower total symptom burden as measured by the Symptom Screening in Pediatrics Tool (SSPedi) compared to usual care among pediatric patients with cancer admitted to a hospital or seen in a clinic daily for at least 5 days. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial enrolled participants from July 2018 to September 2023 from 8 Canadian tertiary care centers that diagnose and treat pediatric patients with cancer. Patients aged 8 to 18 years with cancer expected to be in a hospital or clinic daily for at least 5 consecutive days were eligible for inclusion. Participants were randomized to intervention (n = 176) vs control (n = 169) groups. Data were analyzed from November 2023 to December 2023. INTERVENTION: Intervention participants completed the SSPedi once daily for 5 days. Printed symptom reports were provided daily to the health care team, and email alerts were distributed for severely bothersome symptoms. Control participants received usual care. MAIN OUTCOMES AND MEASURES: The primary outcome was self-reported total SSPedi score on day 5. Secondary outcomes were individual SSPedi symptoms, pain, quality of life, symptom documentation, and intervention provision. The primary analysis compared the day 5 total SSPedi scores between randomized groups using a multiple linear regression model. For the secondary analysis comparing individual SSPedi symptom scores, the odds ratio for the intervention was estimated using a proportional odds model. Pain and quality of life were analyzed using the same approach as the primary outcome. Fisher exact test was used to compare symptom documentation, any intervention, and symptom-specific intervention between groups. RESULTS: A total of 345 participants were enrolled; median (range) participant age was 13.8 (8.0-18.8) years, and 150 participants (43.5%) were female. Day 5 SSPedi score was significantly better with symptom screening compared to usual care (adjusted mean difference, -2.5; 95% CI, -3.8 to -1.2). Symptom screening reduced the odds of higher individual symptom scores; 8 of 15 symptom reductions were statistically significant. There were no significant differences in pain or quality of life scores between groups. Five symptoms were documented or treated significantly more often with symptom screening than usual care. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, among pediatric patients with cancer admitted to a hospital or seen in a clinic daily for at least 5 days, symptom screening with SSPedi improved total symptom scores compared to usual care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03593525.
