OBJECTIVE: To characterize pain and its impact in patients with locally advanced or metastatic urothelial cancer (la/mUC) treated in the first-line setting and to assess the content validity of the Brief Pain Inventory Short Form (BPI-SF) worst pain item in this population.
METHODS: One-hour semi-structured qualitative interviews were conducted in US patients meeting these criteria: aged ≥45 years, physician-confirmed la/mUC receiving first-line treatment, self-reported la/mUC-attributed pain >0 (0 [none] to 10 [as bad as you can imagine] scale) prior to enrollment, and no major surgeries ≤3 months prior to the interview. Patients were asked open-ended questions about their la/mUC symptoms and la/mUC pain (eg, location, impacts on their life); areas of interest not spontaneously mentioned were probed. “Think aloud” cognitive debriefing was conducted for the BPI-SF worst pain item.
RESULTS: Sixteen patients (laUC, n=10; mUC, n=6) were interviewed (mean age, 53.8 years; male, n=8). All patients were diagnosed within ≤5 (mean, 2.73) months of study entry. First-line treatments included cisplatin-containing (n=14) or carboplatin-gemcitabine (n=2) therapies. The average past-week worst pain score was 6.2 (range, 3-10). Pain was the most commonly reported symptom (n=16) related to la/mUC. Pain was frequently reported in the back (n=14) and pelvic/lower abdominal area (n=10). All patients reported that pain impacted their physical and daily activities and most (n=13) reported it impacted overall quality of life. All patients correctly interpreted and easily completed the BPI-SF worst pain item; 15 reported that it was relevant to their la/mUC experience. Patients understood the 24-hour recall period; most supported daily (n=13) or weekly (n=14) assessment and preferred electronic administration using their device (n=14).
CoONCLUSIONS: In patients with la/mUC-attributed pain receiving first-line treatment, these results indicate that pain impacts patients’ lives, including physical and daily activities, and demonstrates BPI-SF worst pain item content validity in this population.
