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• W2966058518 abstract "e19633 Background: NCI PRO-CTCAE is a new patient-reported outcome measure designed to enhance adverse event (AE) reporting in clinical trials by integrating the patient experience. The PRO-CTCAE item bank includes items representing the frequency (F), severity (S) and interference (I) with usual activities of 78 symptomatic AEs. The aim of this study was to examine the acceptability of a subset of PRO-CTCAE items to women receiving treatment for HER2+ MBC. Methods: 207 women on active treatment for HER2+ MBC (median 47 months since MBC diagnosis) were recruited from 6 U.S. breast cancer support groups and completed a web survey that included 18 PRO-CTCAE symptoms. Respondents were aged 45-64 years (71%), white (94%), college-educated (72%), with health-related quality of life rated good to excellent (61%) and median EQ5D utility score of 0.8. To explore PRO-CTCAE acceptability and data quality, we examined item level missingness, endorsement frequencies and binary and free-text responses about the comprehensibility of PRO-CTCAE items. Results: Item level missingness across all symptoms for each PRO-CTCAE dimension (F, S and I) ranged from 1.0% to 5.3%, with a median of 2.9%; interference associated with decreased appetite had the greatest missingness (5.3%). Excluding this outlier, maximum missingness was 3.9%. Endorsement frequencies of response choices for S of insomnia, constipation, fatigue, pain, anxiety/worry and sad/unhappy feelings support acceptable instrument sensitivity (all adjacent response points endorsed by >7% of respondents). Most respondents (92%) thought the items were easy to understand; a few were uncertain about how to rate symptoms such as anxiety, depression, insomnia and nausea if they were present but partially controlled with medication. Conclusions: These findings confirm and extend those of other studies demonstrating the acceptability of PRO-CTCAE. Evaluation in a more heterogeneous sample, particularly with respect to education and cancer site, is underway." @default.
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• W2966058518 date "2012-05-20" @default.
• W2966058518 modified "2023-09-24" @default.
• W2966058518 title "Acceptability of the NCI patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE) in women with metastatic breast cancer (MBC)." @default.
• W2966058518 doi "https://doi.org/10.1200/jco.2012.30.15_suppl.e19633" @default.
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