NCT05236218

Brief Summary

Through our study, we aim to understand the most important factors for patients when they decide on the type of treatment they receive for MIBC. Our study consists of a discrete choice experiment (DCE): a type of questionnaire used to elicit preferences in the absence of data. DCEs are frequently used in oncological research to elicit preferences from participants without directly asking them to state their preferred options. Participants undertaking our DCE questionnaire will presented with a series of alternative hypothetical scenarios containing several variables or "attributes" (5), each of which may have a number of variations or "levels".

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 11, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

July 20, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

March 8, 2023

Status Verified

February 1, 2023

Enrollment Period

9 months

First QC Date

February 2, 2022

Last Update Submit

March 7, 2023

Conditions

Keywords

Muscle invasive bladder cancerPatient Preference

Outcome Measures

Primary Outcomes (1)

  • Willingness to accept treatment attributes, and trade-offs between these, using a study-specific Discrete Choice Experiment (DCE) Questionnaire

    Through study completion, an average of 1 year (Discrete Choice Experiment (DCE) Questionnaire). Trade-off from Marginal Rate of Substitution calculate as percentage points (0 to 100). ]

Study Arms (2)

Pilot study (n = 10)

10 participants will be recruited to complete the questionnaire (version 1). A research assistant will be present to help support them /answer any questions around the format. Readability and comprehension will be noted. Any changes (if needed) can be implemented to its format before the main data collection.

Other: Semi-Structured Interview Patients Interview

Discrete Choice Experiment Questionnaire (n = 50)

Discrete Choice Experiment (DCE) Patients

Other: Discrete Choice Experiment (DCE) Patients DCE Questionnaire

Interventions

Discrete Choice Experiment (DCE) Patients

Discrete Choice Experiment Questionnaire (n = 50)

First version of questionnaire (readability/comprehension check)

Also known as: Pilot study
Pilot study (n = 10)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men or women with diagnosed MIBC who are currently undergoing treatment or have previously completed treatment for MIBC

You may qualify if:

  • Diagnosed with MIBC cancer and currently undergoing treatment or have previously completed treatment for MIBC

You may not qualify if:

  • Any of other type of bladder cancer (unknown, metastatic, or non muscle invasive bladder cancer)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Patient SatisfactionPatient Preference

Interventions

delta 24-sterol reductasePilot Projects

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesEvaluation Studies as TopicHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Simon Hughes

    KCL/GSTTH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2022

First Posted

February 11, 2022

Study Start

July 20, 2022

Primary Completion

April 25, 2023

Study Completion

January 1, 2024

Last Updated

March 8, 2023

Record last verified: 2023-02

Locations