Validity and performance of the Functional Assessment of Cancer Therapy-Bladder (FACT-Bl) among advanced urothelial cancer patients

Abstract

PurposeThe recent increase in emerging novel therapies in the bladder cancer therapeutic area has increased the need for fit-for-purpose patient-reported outcome (PRO) measures for these patients. This study evaluates the psychometric properties of the Functional Assessment of Cancer Therapy-Bladder (FACT-Bl) in 182 patients with advanced urothelial cancer (UC) and fills an important gap by demonstrating its validity for use in clinical trials.MethodsData were collected as part of a multicentre, open-label study of durvalumab in patients with inoperable or metastatic solid tumours. Psychometric properties evaluated include item and subscale characteristics (including correlation analysis), reliability (estimated using Cronbach’s α), validity (by independent sample t test), responsiveness (using mixed models with repeated measures), and clinically meaningful changes using both anchor-based and distribution-based methods.ResultsOne hundred and seventy-two patients completed the FACT-Bl questionnaire at baseline. Many individual items had floor or ceiling effects indicative of minimal symptoms and high functioning. The psychometric properties of the existing established scales were assessed and found to range from acceptable to very good. Internal consistency (most Cronbach’s α coefficients range 0.66–0.85) and stability (test–retest reliability) generally exceeded standards for good reliability (most estimated intraclass correlations [ICCs] exceeded 0.70, although ICCs for some items [e.g. emotional well-being, ICC 0.58; social well-being, ICC 0.66] were lower than 0.70). Evidence for known-group validity of relevant FACT-Bl subscales and total score was demonstrated by significant differences between groups defined by baseline tumour burden and quality of life scores (difference of FACT-Bl total between low/high tumour burden groups 11.72 (p = 0.001); difference between low/high QoL scores groups 30.51 (p < 0.0001)). The FACT-Bl subscale and total scores were responsive to changes in bladder cancer symptom severity. Clinically meaningful changes in FACT-Bl scores were estimated.ConclusionsResults support the use of the FACT-Bl within this patient population in future clinical research.

Quality of Life in Female Patients Following Ileal Neobladder and Ileal Conduit: Where Are We?

“…The Functional Assessment of Cancer Therapy—Bladder Cancer (FACT-BI), consists of 27 questions, which cover similar fields of the FACT-VCI, but has two more questions for patients with a stoma [ 11 ]. It evaluates the physical, social, family, emotional and functional well-being, as well as a condition-specific component that assesses issues related to bladder cancer, such as urinary, bowel, and sexual function.…”

Clinical outcome and quality of life in octogenarian patients with muscle-invasive urothelial carcinoma of the bladder treated with radical cystectomy or transurethral resection of the bladder tumor: a retrospective analysis of 143 patients

“…Degboe et al presented a study of 182 patients diagnosed with urothelial carcinoma of the upper and lower urinary tract. Baseline FACT-G score was 77.2 [ 27 ]. This score was considerably higher than the median baseline score in the present cohort which was assessed at 43.8 points.…”

Clinical evidence for the first-line treatment of advanced urothelial carcinoma: Current paradigms and emerging treatment options

“…Future studies are needed to provide additional HRQoL-related data on first-line treatments, particularly for IO agents. In designing future studies, we recommend that investigators select the instruments that will best elucidate the effects of tolerability, such as Functional Assessment of Cancer Therapy -Bladder Cancer, which was designed to evaluate patient-reported outcomes associated with bladder cancer therapy [63].…”