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).

Sponsor
King's College London (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05236218
Collaborator
(none)
60
22.1

Study Details

Study Description

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".

Condition or Disease Intervention/Treatment Phase
  • Other: Discrete Choice Experiment (DCE) Patients DCE Questionnaire
  • Other: Semi-Structured Interview Patients Interview

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

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Patients' Treatment Preferences For Muscle Invasive Bladder Cancer Cancer: A Discrete Choice Experiment
Anticipated Study Start Date :
Feb 28, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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
First version of questionnaire (readability/comprehension check)
Other Names:
  • Pilot study
  • Discrete Choice Experiment Questionnaire (n = 50)

    Discrete Choice Experiment (DCE) Patients

    Other: Discrete Choice Experiment (DCE) Patients DCE Questionnaire
    Discrete Choice Experiment (DCE) Patients

    Outcome Measures

    Primary Outcome Measures

    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). ]]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • King's College London

    Investigators

    • Principal Investigator: Simon Hughes, KCL/GSTTH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    King's College London
    ClinicalTrials.gov Identifier:
    NCT05236218
    Other Study ID Numbers:
    • PTPDCE
    First Posted:
    Feb 11, 2022
    Last Update Posted:
    Feb 11, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by King's College London
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 11, 2022