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- Title
A tailored phase I-specific patient-reported outcome (PRO) survey to capture the patient experience of symptomatic adverse events.
- Authors
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.
- Abstract
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.
- Publication
British Journal of Cancer, 2023, Vol 129, Issue 4, p612
- ISSN
0007-0920
- Publication type
Article
- DOI
10.1038/s41416-023-02307-w