Muscle Invasive Bladder CancerNCT05236218
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 of Muscle Invasive Bladder Cancer and Surgery, run by King's College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Invasive Bladder Cancer, Surgery, Sexual Wellbeing
- What is being tested?
- Discrete Choice Experiment (DCE) Patients DCE Questionnaire and Semi-Structured Interview Patients Interview
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jul 2022to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men or women with diagnosed MIBC who are currently undergoing treatment or have previously completed treatment for MIBC
Who may be able to join
- Diagnosed with MIBC cancer and currently undergoing treatment or have previously completed treatment for MIBC
Who cannot join
- Any of other type of bladder cancer (unknown, metastatic, or non muscle invasive bladder cancer)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's and St Thomas' NHS Foundation Trust
London
Liam Mannion, liam.mannion@kcl.ac.uk
About this study
Official title: Patients' Treatment Preferences For Muscle Invasive Bladder Cancer Cancer: A Discrete Choice Experiment
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:
- Interviews with experienced healthcare professionals and service users to finalise attributes and levels to be used for the questionnaire
- 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)
- Necessary changes based on feedback from the pilot study will be applied before the main study is carried out
- Conditions
- Muscle Invasive Bladder Cancer, Surgery, Sexual Wellbeing, Patient Satisfaction, Patient Preference
- Being tested
- Discrete Choice Experiment (DCE) Patients DCE Questionnaire, Semi-Structured Interview Patients Interview
- Keywords
- Muscle invasive bladder cancer, Patient Preference
- Medical subject headings
- Patient Satisfaction, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discrete Choice Experiment (DCE) Patients DCE QuestionnaireOther
Discrete Choice Experiment (DCE) Patients
Semi-Structured Interview Patients InterviewOther
Also called Pilot study
First version of questionnaire (readability/comprehension check)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Semi-Structured Interview Patients Interview | |
| Discrete Choice Experiment Questionnaire (n = 50) | Discrete Choice Experiment (DCE) Patients Receives: Other: Discrete Choice Experiment (DCE) Patients DCE Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Willingness to accept treatment attributes, and trade-offs between these, using a study-specific Discrete Choice Experiment (DCE) Questionnaire
Measured: 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). ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start20 Jul 2022
- Primary completion25 Apr 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Hughes, Principal investigator, KCL/GSTTH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236218
- Sponsor's protocol ID
- PTPDCE
- Status last verified
- Feb 2023
- First submitted
- 2 Feb 2022
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients' Treatment Preferences For Muscle Invasive Bladder Cancer Cancer: A Discrete Choice Experiment
- ClinicalTrials.gov ID
- NCT05236218
- Acronym / sponsor ID
- PTPDCE
- Conditions
- Muscle Invasive Bladder Cancer, Surgery, Sexual Wellbeing, Patient Satisfaction, Patient Preference
- Keywords
- Muscle invasive bladder cancer, Patient Preference
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 25 Apr 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Interviews with experienced healthcare professionals and service users to finalise attributes and levels to be used for the questionnaire
- 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)
- Necessary changes based on feedback from the pilot study will be applied before the main study is carried out
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilot study (n = 10) | – | Other: Semi-Structured Interview Patients Interview10 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. |
| Discrete Choice Experiment Questionnaire (n = 50) | – | Other: Discrete Choice Experiment (DCE) Patients DCE QuestionnaireDiscrete Choice Experiment (DCE) Patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men or women with diagnosed MIBC who are currently undergoing treatment or have previously completed treatment for MIBC
Key inclusion criteria (1 listed)
- Diagnosed with MIBC cancer and currently undergoing treatment or have previously completed treatment for MIBC
Key exclusion criteria (1 listed)
- Any of other type of bladder cancer (unknown, metastatic, or non muscle invasive bladder cancer)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discrete Choice Experiment (DCE) Patients DCE QuestionnaireDiscrete Choice Experiment (DCE) Patients | Other | Discrete Choice Experiment Questionnaire (n = 50) |
| Semi-Structured Interview Patients InterviewAlso: Pilot studyFirst version of questionnaire (readability/comprehension check) | Other | Pilot study (n = 10) |
Primary outcome
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). ]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Hughes principal investigator
KCL/GSTTH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Invasive Bladder Cancer and Surgery, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simon Hughes, MD (+44 20 7188 3761, Simon.1.hughes@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). ]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.