SNUGGLE: A Study to Evaluate Treatment Preferences for Japanese Participants With Muscle-invasive Urothelial Carcinoma of the Bladder

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05742867
• Collaborator: Ono Pharmaceutical Co. Ltd (Industry)
• Enrollment: 115
• Anticipated Duration (Months): 8.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Bladder Neoplasms

Study Design

• Study Type: Observational
• Anticipated Enrollment: 115 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Patient Preferences of Treatment for the Patients Suffering From Muscle-invasive Urothelial Carcinoma of Bladder Following Radical Cystectomy in Japan
• Anticipated Study Start Date: Feb 15, 2023
• Anticipated Primary Completion Date: Oct 31, 2023
• Anticipated Study Completion Date: Oct 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1 High-risk Muscle-Invasive Bladder Cancer (MIBC) participants following radical cystectomy

Outcome Measures

Primary Outcome Measures

1. Overall survival [Up to 1 year after radical cystectomy]

   Median overall survival (years)

2. 5-year survival rate [Up to 1 year after radical cystectomy]

   Defined as the percentage of patients that are alive after 5 years

3. Disease-free survival (DFS) [Up to 1 year after radical cystectomy]

   Median disease-free survival (year)

4. Probability of side effect-related treatment discontinuation [Up to 1 year after radical cystectomy]

   Defined as the percent likelihood that a patient will stop treatment due to a side effect

5. Number of participants who experience treatment side effects [Up to 1 year after radical cystectomy]

   Defined as the percentage of participants who experience nausea, diarrhea, fatigue, skin-related side effects (e.g. pruritus, rash), endocrine system-related side effects (e.g. hypothyroidism), anemia, alopecia, reduced renal function, cardiac impairment, leukopenia, neutropenia, and thrombocytopenia due to treatment

6. Overall severity of side effects [Up to 1 year after radical cystectomy]

   Defined as the severity of side effects categorized as "None", "mild-to-moderate", or "severe"

7. Treatment Convenience [Up to 1 year after radical cystectomy]

   Defined as the route of administration and frequency of administration per day or week (Infusions once every week, 2 weeks, or 4 weeks)

8. Treatment duration [Up to 1 year after radical cystectomy]

   Defined as the total duration for continuous administration of treatment categorized as 2 months, 4 months, or 1 year

9. Hospitalization [Up to 1 year after radical cystectomy]

   Defined as the length of hospitalization required for administration of treatment categorized as 0 days (no hospitalization required for administration of treatment), 1 week, or more than 1 week

10. Frequency of outpatient consultations [Up to 1 year after radical cystectomy]

    Defined as the number of outpatient consultations required for treatment administration and monitoring categorized as every 2 weeks, 4 weeks, or 3 months

11. Annual treatment costs [Up to 1 year after radical cystectomy]

    Defined as the annual out-of-pocket treatment costs, categorized as 10,000, 300,000, or 650,000 JPY

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bristol-Myers Squibb
• Ono Pharmaceutical Co. Ltd

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls
• BMS Clinical Trial Patient Recruiting

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT05742867
• Other Study ID Numbers: CA209-6M4
• First Posted: Feb 24, 2023
• Last Update Posted: Feb 24, 2023
• Last Verified: Feb 1, 2023

• Additional relevant MeSH terms: Carcinoma, Transitional Cell; Urinary Bladder Neoplasms

Study Results

No Results Posted as of Feb 24, 2023