Cognitive Interview-Based Validation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in Adolescents with Cancer

Context The National Cancer Institute created the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to allow direct input on symptomatic adverse events (AEs) from adult patients in oncology trials. Objectives This study sought to determine the youngest age to complete the PRO-CTCAE, evaluated comprehension of PRO-CTCAE among adolescents, tested new items not currently in PRO-CTCAE, and tested a parent-proxy version. Methods From seven pediatric cancer hospitals, 51 adolescents (13–20 years) receiving cancer treatment participated, along with 40 parent proxies. We evaluated 55 AEs from the PRO-CTCAE library (97 questions) and seven new AEs not in PRO-CTCAE that assess symptom frequency, severity, interference, or presence. Questions were distributed across three forms to reduce burden. Cognitive interviews with retrospective probing were completed in age groups of 13–15 and 16–20 year olds. Proxies were interviewed independently. Results In general, the 16–20 year olds and the parent proxies were able to understand and complete the PRO-CTCAE and newly designed AE questions. Five PRO-CTCAE terms (bloating of the abdomen, anxiety, flashing lights in front of your eyes, hot flashes, and bed sores) and the wording of the questions about AE severity were challenging for a few adolescents and proxies. The 13–15 year olds had greater challenges completing the PRO-CTCAE. Conclusion This study extends use of the adult PRO-CTCAE for adolescents as young as 16 years and proposes new questions for seven new symptomatic AEs and a parent-proxy version of PRO-CTCAE. Additional testing of the new questions and alternative language for more challenging PRO-CTCAE items is recommended in adults

Can Steps per Day Reflect Symptoms in Children and Adolescents Undergoing Cancer Treatment?

BACKGROUND: Multiple symptoms occur in children receiving cancer therapy. Decreased steps per day may be associated with burdensome symptoms. OBJECTIVE: To evaluate associations between self-reported symptoms (pain interference, anxiety, depressive symptoms, psychological stress, and fatigue) and function (physical function-mobility and physical activity) and cumulative symptom count with steps per day. METHODS: Five sites enrolled English-speaking children, 8 to 17 years, receiving treatment for a first cancer diagnosis. Patient-reported outcome (PRO) surveys were administered before (T1) and after (T2) a course of chemotherapy. Garmin VivoFit 3 (Garmin International, Olathe, KS) accelerometers were worn 7 days prior to each data point. Univariate changes in scores over time were evaluated with dependent-sample t tests. Pearson correlations examined associations between PRO domains and step count. Multivariable mixed-effect models examined associations between steps and PROs. RESULTS: Participants\u27 (n = 65) steps per day decreased during treatment (4099 [T1] and 3135 [T2]; P \u3c .01), with larger reductions observed during hospitalization and in younger children compared with adolescents. Steps significantly correlated with PROMIS (Patient-Reported Outcome Measurement Information System) Pediatric physical activity and physical function-mobility. Decreased steps per day were associated with increased fatigue and cumulative symptom count. CONCLUSIONS: In children and adolescents with cancer, steps per day can serve as an indicator of fatigue, cumulative symptom count, physical activity, and physical functioning-mobility. IMPLICATIONS FOR PRACTICE: Child self-reports of physical activity and physical function are valid during cancer therapy and should be captured. In the absence of self-report, decreasing step count may prompt additional assessments related to fatigue or cumulative symptom count and trigger early interventions to support physical activity and physical function-mobility

Cognitive Interview-Based Validation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in Adolescents with Cancer.

CONTEXT: The National Cancer Institute created the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to allow direct input on symptomatic AEs from adult patients in oncology trials. OBJECTIVES: This study sought to determine the youngest age to complete the PRO-CTCAE, evaluated comprehension of PRO-CTCAE among adolescents, tested new items not currently in PRO-CTCAE, and tested a parent-proxy version. METHODS: From 7 pediatric cancer hospitals, 51 adolescents (13–20 years) receiving cancer treatment participated, along with 40 parent-proxies. We evaluated 55 AEs from the PRO-CTCAE library (97 questions) and 7 new AEs not in PRO-CTCAE that assess symptom frequency, severity, interference, or presence. Questions were distributed across 3 forms to reduce burden. Cognitive interviews with retrospective probing were completed in age groups of 13–15 and 16–20 year-olds. Proxies were interviewed independently. RESULTS: In general, the 16–20 year-olds and the parent-proxies were able to understand and complete the PRO-CTCAE and newly designed AE questions. Five PRO-CTCAE terms (bloating of the abdomen, anxiety, flashing lights in front of your eyes, hot flashes, bed sores) and the wording of the questions about AE severity were challenging for a few adolescents and proxies. The 13–15 year-olds had greater challenges completing the PRO-CTCAE. CONCLUSIONS: This study extends use of the adult PRO-CTCAE for adolescents as young as 16 years, and proposes new questions for 7 new symptomatic AEs and a parent-proxy version of PRO-CTCAE. Additional testing of the new questions and alternative language for more challenging PRO-CTCAE items is recommended in adults