CClinicalTrials.gg
Status unknownNCT05236218Updated Mar 8, 2023

To Better Understand the Most Important Factors for Patients When They Decide on the Type of Treatment They Receive for Muscle Invasive Bladder Cancer (MIBC).

An observational study in Muscle Invasive Bladder Cancer, Surgery and Sexual Wellbeing, sponsored by King's College London. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-08.

Sponsored by King's College London · Observational

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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".

Read the detailed description

The study will be conducted using validated and established protocols for undertaking DCEs. A literature review was undertaken to assess what the most important considerations where for patients when making decisions about the treatment they receive for MIBC. Using this literature search as a starting point, discussion groups with relevant healthcare professionals and service users were undertaken to decide on the final attribute and levels for the questions. Five attributes were selected through an iterative process - Body image, Life expectancy, Side-effects from treatment, Living as bladder cancer survivor, and Sexual wellbeing

The study is divided into three stages:

  1. Interviews with experienced healthcare professionals and service users to finalise attributes and levels to be used for the questionnaire
  2. A representative sample of patients (\~10) will be asked to complete the questionnaire in addition to a brief unstructured interview to assess understanding (e.g. readability and ease of completing the questionnaire)
  3. Necessary changes based on feedback from the pilot study will be applied before the main study is carried out
02

Conditions studied

  • Muscle Invasive Bladder Cancer
  • Surgery
  • Sexual Wellbeing
  • Patient Satisfaction
  • Patient Preference

Keywords

  • Muscle invasive bladder cancer
  • Patient Preference
03

In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's planned enrollment of 60 is below the median of 180 across 374 observational studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

King's College London is the lead sponsor of 507 studies on the registry; 125 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Any of other type of bladder cancer (unknown, metastatic, or non muscle invasive bladder cancer)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherDiscrete Choice Experiment (DCE) Patients DCE Questionnaire

    Discrete Choice Experiment (DCE) Patients

  • OtherSemi-Structured Interview Patients Interview

    First version of questionnaire (readability/comprehension check)

    Also known as: Pilot study

06

What researchers measure

Primary outcomes

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

    Time frame: 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). ]

07

Study locations

1 of 1 sites recruiting
  • Guy's and St Thomas' NHS Foundation Trust
    London, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05236218
Lead sponsor
King's College London
Responsible party
Sponsor
First posted
Feb 11, 2022
Start date
Jul 20, 2022
Primary completion
Apr 25, 2023 (estimated)
Completion
Jan 1, 2024 (estimated)
Last update
Mar 8, 2023

Study contacts

Simon Hughes, MD
Contact
Simon.1.hughes@kcl.ac.uk
+44 20 7188 3761
Liam Mannion
Contact
Liam.mannion@kcl.ac.uk
+44 20 7140 5685
Simon Hughes
principal investigator · KCL/GSTTH

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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