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A tailored phase I-specific patient-reported outcome (PRO) survey to capture the patient experience of symptomatic adverse events

BACKGROUND: Patient perspectives are fundamental to defining tolerability of investigational anti-neoplastic therapies in clinical trials. Phase I trials present a unique challenge in designing tools for efficiently collecting patient-reported outcomes (PROs) given the difficulty of anticipating adv...

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Detalles Bibliográficos
Autores principales: Janse van Rensburg, Helena J., Liu, Zhihui, Watson, Geoffrey A., Veitch, Zachary W., Shepshelovich, Daniel, Spreafico, Anna, Abdul Razak, Albiruni R., Bedard, Philippe L., Siu, Lillian L., Minasian, Lori, Hansen, Aaron R.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10421959/
https://www.ncbi.nlm.nih.gov/pubmed/37419999
http://dx.doi.org/10.1038/s41416-023-02307-w
Descripción
Sumario:BACKGROUND: Patient perspectives are fundamental to defining tolerability of investigational anti-neoplastic therapies in clinical trials. Phase I trials present a unique challenge in designing tools for efficiently collecting patient-reported outcomes (PROs) given the difficulty of anticipating adverse events of relevance. However, phase I trials also offer an opportunity for investigators to optimize drug dosing based on tolerability for future larger-scale trials and in eventual clinical practice. Existing tools for comprehensively capturing PROs are generally cumbersome and are not routinely used in phase I trials. METHODS: Here, we describe the creation of a tailored survey based on the National Cancer Institute’s PRO-CTCAE for collecting patients’ perspectives on symptomatic adverse events in phase I trials in oncology. RESULTS: We describe our stepwise approach to condensing the original 78-symptom library into a modified 30 term core list of symptoms which can be efficiently applied. We further show that our tailored survey aligns with phase I trialists’ perspectives on symptoms of relevance. CONCLUSIONS: This tailored survey represents the first PRO tool developed specifically for assessing tolerability in the phase I oncology population. We provide recommendations for future work aimed at integrating this survey into clinical practice.