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).

NCT ID: NCT05236218

Last Updated: 2023-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-20

Study Completion Date

2024-01-01

Brief Summary

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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".

Detailed Description

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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

Conditions

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Muscle Invasive Bladder Cancer Surgery Sexual Wellbeing Patient Satisfaction Patient Preference

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Semi-Structured Interview Patients Interview

Intervention Type OTHER

First version of questionnaire (readability/comprehension check)

Discrete Choice Experiment Questionnaire (n = 50)

Discrete Choice Experiment (DCE) Patients

Discrete Choice Experiment (DCE) Patients DCE Questionnaire

Intervention Type OTHER

Discrete Choice Experiment (DCE) Patients

Interventions

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Discrete Choice Experiment (DCE) Patients DCE Questionnaire

Discrete Choice Experiment (DCE) Patients

Intervention Type OTHER

Semi-Structured Interview Patients Interview

First version of questionnaire (readability/comprehension check)

Intervention Type OTHER

Other Intervention Names

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Pilot study

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Simon Hughes

Role: PRINCIPAL_INVESTIGATOR

KCL/GSTTH

Locations

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Guy's and St Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Simon Hughes, MD

Role: CONTACT

+44 20 7188 3761

Liam Mannion

Role: CONTACT

+44 20 7140 5685

Facility Contacts

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Liam Mannion

Role: primary

Other Identifiers

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PTPDCE

Identifier Type: -

Identifier Source: org_study_id

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