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).

Surgery Clinical Trial

Official title:

Patients' Treatment Preferences For Muscle Invasive Bladder Cancer Cancer: A Discrete Choice Experiment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05236218
• Other study ID #: PTPDCE
• Status: Recruiting
• Start date: July 20, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: February 2023
• Source: King's College London
• Contact: Simon Hughes, MD
• Phone: +44 20 7188 3761
• Email: Simon.1.hughes[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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".

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 1, 2024
• Est. primary completion date: April 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Muscle Invasive Bladder Cancer
• Patient Preference
• Patient Satisfaction
• Surgery
• Urinary Bladder Neoplasms

Intervention

Other:
• Discrete Choice Experiment (DCE) Patients DCE Questionnaire
Discrete Choice Experiment (DCE) Patients
• Semi-Structured Interview Patients Interview
First version of questionnaire (readability/comprehension check)

Locations

Country	Name	City	State
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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). ]