An evaluation on quality of life during participation in early phase clinical trials in paediatric oncology

An evaluation on quality of life during participation in early phase clinical trials in paediatric oncology | Authorea try { document.documentElement.classList.add('js'); } catch (e) { } var _gaq = _gaq || []; _gaq.push(['_setAccount', 'G-8VDV14Y67G']); _gaq.push(['_trackPageview']); (function() { var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = ('https:' == document.location.protocol ? 'https://ssl' : 'http://www') + '.google-analytics.com/ga.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(ga, s); })(); Skip to main content Preprints Collections Wiley Open Research IET Open Research Ecological Society of Japan All Collections About About Authorea FAQs Contact Us Quick Search anywhere Search for preprint articles, keywords, etc. Search Search ADVANCED SEARCH SCROLL Pediatric Blood & Cancer This is a preprint and has not been peer reviewed. Data may be preliminary. 29 April 2025 V1 Latest version Share on An evaluation on quality of life during participation in early phase clinical trials in paediatric oncology Authors : Alba Rubio-San-Simon 0000-0001-6426-7423 , Susana Buendía , Juan Rubio Gómez , Teresa de Rojas 0000-0001-7749-8423 , Luis Madero , Francisco Bautista 0000-0002-0421-8862 [email protected] , and Lucas Moreno 0000-0002-0708-1670 Authors Info & Affiliations https://doi.org/10.22541/au.174595026.63628081/v1 Published Pediatric Blood & Cancer Version of record Peer review timeline 315 views 221 downloads Contents Abstract Supplementary Material Information & Authors Metrics & Citations View Options References Figures Tables Media Share Abstract Background Given the poor prognoses and potential treatment toxicities faced by pediatric patients in early-phase oncology trials, evaluating quality of life (QoL) is crucial for both families and physicians when considering patient recruitment. This prospective, longitudinal study evaluates the impact of trial participation on QoL in children, agreement between self-reports, proxy-reports, and physician assessments, and associations with demographic and clinical factors. Procedure Patients aged 5–18 years enrolled in phase I/II clinical trials at Hospital Niño Jesus from 2019 to 2023 and their caregiver proxies were eligible. PedsQL 3.0 Cancer Module was independently completed by children and proxies at baseline, day +30, and day +90 of cycle 1 day 1. Stratified analyses by gender, age, tumor type, outcome, reason of end of treatment, and trial characteristics were performed. Agreement between child, proxy, and investigator responses was measured. Results Ninety-three pediatric patients with cancer and their proxies were included. The 38.71% of patients and 33.33% of proxies experienced a clinically relevant change in QoL scores after 30 days. Patients in phase II trials demonstrated greater QoL improvements compared to phase I (p = 0.0061). No significant associations were found between improvement of QoL and demographic or clinical factors. Proxies consistently reported lower QoL scores than patients, while physicians underestimated symptom severity compared to patient-reported outcomes. Conclusions Trial participation aligns with maintaining or improving QoL, particularly in later-phase trials. Discrepancies among patient, proxy, and investigator perspectives underscore the necessity of multi-informant tools to capture comprehensive insights. Supplementary Material File (an evaluation on quality of life.docx) Download 5.27 MB Information & Authors Information Version history V1 Version 1 29 April 2025 Peer review timeline Published Pediatric Blood & Cancer Version of Record 21 Jul 2025 Published Copyright This work is licensed under a Non Exclusive No Reuse License. Collection Pediatric Blood & Cancer Keywords new agents outcomes research phase i clinical trials phase ii clinical trials quality of life Authors Affiliations Alba Rubio-San-Simon 0000-0001-6426-7423 Hospital Infantil Universitario Nino Jesus View all articles by this author Susana Buendía Hospital Infantil Universitario Nino Jesus View all articles by this author Juan Rubio Gómez Universidad de Valladolid View all articles by this author Teresa de Rojas 0000-0001-7749-8423 ACCELERATE View all articles by this author Luis Madero Hospital Infantil Universitario Nino Jesus View all articles by this author Francisco Bautista 0000-0002-0421-8862 [email protected] Prinses Maxima Centrum voor Kinderoncologie BV View all articles by this author Lucas Moreno 0000-0002-0708-1670 Hospital Universitari Vall d'Hebron View all articles by this author Metrics & Citations Metrics Article Usage 315 views 221 downloads .FvxKWukQNSOunydq8rnd { width: 100px; } Citations Download citation Alba Rubio-San-Simon, Susana Buendía, Juan Rubio Gómez, et al. An evaluation on quality of life during participation in early phase clinical trials in paediatric oncology. Authorea . 29 April 2025. DOI: https://doi.org/10.22541/au.174595026.63628081/v1 If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download. For more information or tips please see 'Downloading to a citation manager' in the Help menu . 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