Metastatic Prostate Cancer Men's Attitudes Towards Treatment of the Local Tumour and Metastasis Evaluative Research
NCT ID: NCT04590976
Last Updated: 2023-02-08
Study Results
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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COMPLETED
320 participants
OBSERVATIONAL
2020-12-03
2023-02-01
Brief Summary
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Novel local cytoreductive treatments and metastasis directed therapy are being evaluated, these can confer additional harm, but might improve survival.
We aim to elicit men's preferences for and willingness to accept trade-offs between potential improved survival and cytoreductive treatment risks using a 'discrete choice experiment'.
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Detailed Description
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PHASE: Prospective multi-centre observational cohort
DESIGN: Discrete choice experiment, single-visit, electronic questionnaire design
SAMPLE SIZE: Multi-centre Stage (Stage 3) n = 300 patients
POPULATION: Men with newly-diagnosed metastatic prostate cancer who have not consented to a form of local cytoreductive or metastasis directed therapy.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthcare Professionals (n = 5)
Intervention: Single, Semi-Structure Interview to identify and define the key attributes associated with treatment options that would warrant trade-off evaluation. These will be used to create the first version of the questionnaire
Semi-Structured Interview Healthcare Professional
Interview
Stage 1 (n = 5)
Intervention: Single, Semi-Structure Interview to identify and define the key attributes associated with treatment options that would warrant trade-off evaluation. These will be used to create the first version of the questionnaire
Semi-Structured Interview Patients
Interview
Stage 2 (n = 10)
Intervention: Single, "Think Aloud Interview" Interview. These will be analysed using an inductive thematic analysis by at least two researchers. Common themes will be extracted by researchers individually and then discussed and agreed.
Think Aloud Interview Patients
Interview
Stage 3 (n = 300)
Intervention: Single, Discrete Choice Experiment Questionnaire at Enrollment Visit
Discrete Choice Experiment (DCE) Patients
DCE Questionnaire
Interventions
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Semi-Structured Interview Healthcare Professional
Interview
Semi-Structured Interview Patients
Interview
Think Aloud Interview Patients
Interview
Discrete Choice Experiment (DCE) Patients
DCE Questionnaire
Eligibility Criteria
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Inclusion Criteria
2. Performance status 0-2
Exclusion Criteria
2. Patient has consented to a form of local cytoreductive treatment to prostate
3. Patient has consented to a form of metastasis directed therapy
18 Years
MALE
No
Sponsors
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University of Aberdeen
OTHER
Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Hashim Ahmed, PhD, FRCS
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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NHS Grampion
Aberdeen, , United Kingdom
Besti Cadwaladr University
Bangor, , United Kingdom
Ysbyty Gwynedd Hospital
Bangor, , United Kingdom
Hamphire Hospitals NHS Foundation Trust
Basingstoke, , United Kingdom
Royal Bath United Hospital
Bath, , United Kingdom
Bedford Hospital
Bedford, , United Kingdom
Royal Bolton Hospital
Bolton, , United Kingdom
Brighton and Sussex hospital
Brighton, , United Kingdom
East Suffolk and North Essex NHS Foundation Trust
Colchester, , United Kingdom
Dartford and Gravsham NHS Trust
Dartford, , United Kingdom
Royal Devon and Exeter Hospital
Exeter, , United Kingdom
Medway NHS Foundation Trust
Gillingham, , United Kingdom
Northern Lincolnshire and Goole NHS Foundation Trust
Grimsby, , United Kingdom
Royal Surrey County Hospital NHS Foundation Trust
Guildford, , United Kingdom
Imperial College London
Hammersmith, , United Kingdom
North Tees and Hartlepool NHS Foundation Trust
Hartlepool, , United Kingdom
West Middlesex University Hospital
Isleworth, , United Kingdom
Queen Elizabeth Hospital
Kings Lynn, , United Kingdom
Kingston Hospital NHS Foundation Trust
Kingston, , United Kingdom
Chelsea and Westminster Hospital
London, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
The Royal Marsden NHS Foundation Trust, Chelsea Research Centre
London, , United Kingdom
Luton and Dunstable University Hospital
Luton, , United Kingdom
Wirral University Teaching Hospital Nhs Foundation
Metropolitan Borough of Wirral, , United Kingdom
Freeman Hospital, Newcastle, Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Nottingham University Hospital
Nottingham, , United Kingdom
University Hospitals Dorset NHS Foundation Trust
Poole, , United Kingdom
East Surrey Hospital
Redhill, , United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, , United Kingdom
Southampton General Hospital, University Hospital Southampton NHS Foundation Trust (UHS)
Southampton, , United Kingdom
East and North Hertfordshire Nhs Trust
Stevenage, , United Kingdom
Sunderland Royal Hospital, City Hospitals Sunderland NHS Foundation Trust
Sunderland, , United Kingdom
Musgrove Park Hospital - Somerset NHS Foundation Trust
Taunton, , United Kingdom
The Royal Cornwall Hospital
Truro, , United Kingdom
Wrexham Maelor
Wrexham, , United Kingdom
Countries
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References
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Connor MJ, Genie MG, Gonzalez M, Sarwar N, Thippu Jayaprakash K, Horan G, Hosking-Jervis F, Klimowska-Nassar N, Sukumar J, Pokrovska T, Basak D, Robinson A, Beresford M, Rai B, Mangar S, Khoo V, Dudderidge T, Falconer A, Winkler M, Watson V, Ahmed HU. Metastatic prostate cancer men's attitudes towards treatment of the local tumour and metastasis evaluative research (IP5-MATTER): protocol for a prospective, multicentre discrete choice experiment study. BMJ Open. 2021 Nov 18;11(11):e048996. doi: 10.1136/bmjopen-2021-048996.
Other Identifiers
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276834
Identifier Type: -
Identifier Source: org_study_id
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