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Exploration of baseline patient-reported side effect bother from cancer therapy

Roydhouse, J, King-Kallimanis, BL, Roy, P, Weinstock, C, Krol, D, Daniels, SR, Suzman, DL, Beaver, JA and Kluetz, PG 2020 , 'Exploration of baseline patient-reported side effect bother from cancer therapy' , Clinical Trials , pp. 1-6 , doi: 10.1177/1740774520910389.

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Abstract

Background: Patient reports of expected treatment side effects are increasingly collected as part of the assessmentof patient experience in clinical trials. A global side effect item that is patient-reported has the potential to inform overalltolerability. Therefore, the aim of this study was to examine the completion and distribution of such a global singleitemmeasure of side effect burden in five cancer clinical trials.Methods: Data from five trials from internal Food and Drug Administration databases that included the FunctionalAssessment of Cancer Therapy–General single-item measure of overall side effect burden (i.e. impact on degree ofbother) were analyzed. Completion rates for the side effect bother item, items adjacent to this item, and two nonadjacentitems on the Functional Assessment of Cancer Therapy–General that are related to health-related quality of lifewere calculated at the baseline assessment and at the 3-month assessment. To evaluate the distribution, the percentageof patients reporting high levels (quite a bit or very much bother) of side effect bother at baseline and 3 months wasassessed.Results: Completion rates for all items were at least 80% regardless of time point or trial population. However, inthree of the five trials, completion rates for the side effect bother item were lower at baseline compared to adjacentand non-adjacent items. This difference was not observed at 3 months. Up to 9.4% of patients reported high levels ofside effect bother at baseline.Conclusion: Patients may enter trials already reporting some bother from side effects. This can make interpretationof results with respect to the investigational agent under study challenging. Patients may skip an item evaluating sideeffect bother at baseline, suggesting some difficulty with interpretation of what is being asked. Further study of thewording and utility of a baseline side effect bother assessment is warranted.

Item Type: Article
Authors/Creators:Roydhouse, J and King-Kallimanis, BL and Roy, P and Weinstock, C and Krol, D and Daniels, SR and Suzman, DL and Beaver, JA and Kluetz, PG
Keywords: side effect, trial, cancer, patient-reported outcome
Journal or Publication Title: Clinical Trials
Publisher: Sage Publications Ltd.
ISSN: 1740-7745
DOI / ID Number: 10.1177/1740774520910389
Copyright Information:

Copyright 2020 The Authors

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