Objectives: Urothelial carcinomas are the most common form of bladder cancer and is most often the origination point for bladder tumors. Patients with bladder cancer experience significant declines in physical, mental, and social health-related quality of life (HRQoL). The Functional Assessment of Bladder Cancer -Bladder (FACT-Bl) is a measure that can be used to assess patient-reported symptoms and HRQOL among bladder cancer patients but has not been fully tested in Stage IV cancer patients. Clinical Outcomes Solutions (COS) conducted qualitative interviews to examine the appropriateness and validity of the FACT-Bl and confirm the relevance of individual symptom items within the FACT-Bl that are considered proximal to the experience of advanced bladder cancer. Methods: COS conducted concept elicitation (CE) and cognitive debriefing (CD) interviews with ten participants with stage IV bladder cancer and five oncology nurses. CE focused on participants' experiences living with bladder cancer to confirm whether the major disease symptoms and impacts are covered in the FACT-Bl. CD examined the relevance and understanding of items, especially those related to urinary symptoms. Thresholds for meaningful improvement and worsening were also investigated. Results: Majority of the concepts assessed in the FACT-Bl were reported spontaneously by participants and nurses, indicating relevance to this population. Of the three urinary-specific symptom items, two (frequency and urgency), were found to be highly relevant in this population, but painful urination was not as relevant. Most often, a change of one point (worsening or improvement) on these items was reported as meaningful. Conclusions: The FACT-Bl is generally fit for purpose, relevant for use and, allows for an accurate assessment of symptom burden and HRQoL impact in this population. The FACT-Bl may be useful in measuring worsening in urinary symptoms when assessing outcome of new interventions given the relevance of these symptoms in this patient population.
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