Clinical trial NCT05236218: 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).
Official title: Patients' Treatment Preferences For Muscle Invasive Bladder Cancer Cancer: A Discrete Choice Experiment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Muscle Invasive Bladder Cancer
Surgery
Sexual Wellbeing
Patient Satisfaction
Patient Preference
Keywords: Muscle invasive bladder cancer
Patient Preference
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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".

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

Eligibility criteria: 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)

Primary outcomes:
measure: Willingness to accept treatment attributes, and trade-offs between these, using a study-specific Discrete Choice Experiment (DCE) Questionnaire
timeFrame: 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). ]
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
affiliation: KCL/GSTTH
name: Simon Hughes
role: PRINCIPAL_INVESTIGATOR
References: