Clinical trial NCT05742867: A Study to Evaluate Treatment Preferences for Japanese Participants With Muscle-invasive Urothelial Carcinoma of the Bladder
Official title: Patient Preferences of Treatment for the Patients Suffering From Muscle-invasive Urothelial Carcinoma of Bladder Following Radical Cystectomy in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Bladder Neoplasms
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2023-02-24
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is composed of 115 Japanese participants, 18 years and older, with muscle-invasive urothelial carcinoma of the bladder following radical cystectomy.

Brief summary: The main purpose of this study is to identify important treatment attributes for post-radical cystectomy (RC) treatment for participants with MIBC (Muscle-Invasive Bladder Cancer) and assess the relative importance of treatment attributes for post-RC treatment in Japan.


Eligibility criteria: Inclusion Criteria:

* Must reside in Japan and able to speak/read Japanese for the interview/survey
* Must have a clinical diagnosis of Muscle-invasive bladder cancer (MIBC):

  * ypT2-ypT4a or ypN+ MIBC, with prior neoadjuvant cisplatin chemotherapy and underwent radical cystectomy
  * pT3-pT4a or pN+ MIBC, without prior neoadjuvant cisplatin chemotherapy and underwent radical cystectomy
* Must not have received any treatment related to MIBC after radical cystectomy

Exclusion Criteria:

* Determined by the physician as being unsuitable for the study (e.g. having any clinically significant psychiatric disorder, cognitive impairment, or having difficulty with communicating in Japanese)
* Confirmed diagnosis of other primary cancers at the time of obtaining consent
* Current participation in a MIBC clinical trial

Primary outcomes:
measure: Overall survival
timeFrame: Up to 1 year after radical cystectomy
measure: 5-year survival rate
timeFrame: Up to 1 year after radical cystectomy
measure: Disease-free survival (DFS)
timeFrame: Up to 1 year after radical cystectomy
measure: Probability of side effect-related treatment discontinuation
timeFrame: Up to 1 year after radical cystectomy
measure: Number of participants who experience treatment side effects
timeFrame: Up to 1 year after radical cystectomy
measure: Overall severity of side effects
timeFrame: Up to 1 year after radical cystectomy
measure: Treatment Convenience
timeFrame: Up to 1 year after radical cystectomy
measure: Treatment duration
timeFrame: Up to 1 year after radical cystectomy
measure: Hospitalization
timeFrame: Up to 1 year after radical cystectomy
measure: Frequency of outpatient consultations
timeFrame: Up to 1 year after radical cystectomy
measure: Annual treatment costs
timeFrame: Up to 1 year after radical cystectomy
Secondary outcomes:
Other outcomes:
Locations:
city: Morrisville
country: United States
facility: Local Institution - 0001
state: North Carolina
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: