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

Clinical Trials : Journal of the Society for Clinical Trials
Jessica K RoydhousePaul G Kluetz

Abstract

Patient reports of expected treatment side effects are increasingly collected as part of the assessment of patient experience in clinical trials. A global side effect item that is patient-reported has the potential to inform overall tolerability. Therefore, the aim of this study was to examine the completion and distribution of such a global single-item measure of side effect burden in five cancer clinical trials. Data from five trials from internal Food and Drug Administration databases that included the Functional Assessment of Cancer Therapy-General single-item measure of overall side effect burden (i.e. impact on degree of bother) were analyzed. Completion rates for the side effect bother item, items adjacent to this item, and two non-adjacent items on the Functional Assessment of Cancer Therapy-General that are related to health-related quality of life were calculated at the baseline assessment and at the 3-month assessment. To evaluate the distribution, the percentage of patients reporting high levels (quite a bit or very much bother) of side effect bother at baseline and 3 months was assessed. Completion rates for all items were at least 80% regardless of time point or trial population. However, in three of the five tria...Continue Reading

References

Sep 1, 2004·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Erik K FrommeTomasz M Beer
Mar 12, 2010·The New England Journal of Medicine·Ethan Basch
Jan 14, 2016·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Paul G KluetzRichard Pazdur
Aug 25, 2018·Clinical Trials : Journal of the Society for Clinical Trials·Andrew BottomleyCorneel Coens

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