Feasibility Assessment of Patient Reporting of Symptomatic Adverse Events in Multicenter Cancer Clinical Trials.

ABSTRACT:

Importance

In cancer clinical trials, symptomatic adverse events (AEs), such as nausea, are reported by investigators rather than by patients. There is increasing interest to collect symptomatic AE data via patient-reported outcome (PRO) questionnaires, but it is unclear whether it is feasible to implement this approach in multicenter trials.

Objective

To examine whether patients are willing and able to report their symptomatic AEs in multicenter trials.

Design, setting, and participants

A total of 361 consecutive patients enrolled in any 1 of 9 US multicenter cancer treatment trials were invited to self-report 13 common symptomatic AEs using a PRO adaptation of the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) via tablet computers

SUBMITTER: Basch E 

PROVIDER: S-EPMC5553624 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature