Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Aberdeen | OTHER |
Not provided
Not provided
Not provided
Not provided
Systemic therapy (i.e Androgen Deprivation Therapy with Docetaxel, Enzalutamide, Apalutamide or Abiraterone Acetate) has increased overall survival in men with hormone-sensitive metastatic prostate cancer.
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'.
OBJECTIVES: To determine the attributes associated with treatment that are most important to men with hormone-sensitive metastatic prostate cancer (mPCa). To determine men's preferences for, and trade-offs between, the attributes (survival and side-effects) of different treatment options in metastatic prostate cancer including systemic therapy, local and metastases-directed physical therapies.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
| |
| 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. |
| |
| Stage 3 (n = 300) | Intervention: Single, Discrete Choice Experiment Questionnaire at Enrollment Visit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semi-Structured Interview Healthcare Professional | Other | Interview |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment attribute preferences as assessed using a study-specific think aloud interview. | Qualitative work derived from "Think Aloud Interviews". Treatments include radiotherapy, surgery, ablation and metastasis directed therapy. | Through study completion, an average of 3 months [Stage 2] (Think Aloud Interview). |
| Willingness to accept treatment attributes, and trade-offs between these, using a study-specific Discrete Choice Experiment (DCE) Questionnaire | Utility values obtained via multinominal logit estimates from discrete choice experiment | Through study completion, an average of 1 year [Stage 3] (Discrete Choice Experiment (DCE) Questionnaire). Trade-off from Marginal Rate of Substitution calculate as percentage points (0 to 100). |
| Measure | Description | Time Frame |
|---|---|---|
| Willingness to accept the potential effect sizes that are shown in trials. | Derived from discrete choice experiment finding analysed alongside reported outcomes from ongoing therapeutic trials. | Through study completion, an average of 1 year [Stage 3] (Discrete Choice Experiment (DCE) Questionnaire). No scale. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Men with newly-diagnosed hormone-sensitive metastatic prostate cancer who have not consented to a form of local cytoreductive or metastasis directed therapy.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hashim Ahmed, PhD, FRCS | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NHS Grampion | Aberdeen | United Kingdom | ||||
| Besti Cadwaladr University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34794989 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 17, 2024 | |
| Unrelease | Jul 18, 2024 | |
| Release | Jul 18, 2024 |
Not provided
Not provided
Not provided
Not provided
| Semi-Structured Interview Patients |
| Other |
Interview |
|
| Think Aloud Interview Patients | Other | Interview |
|
| Discrete Choice Experiment (DCE) Patients | Other | DCE Questionnaire |
|
| 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 | TW7 6AF | United Kingdom |
| Queen Elizabeth Hospital | Kings Lynn | PE30 4ET | United Kingdom |
| Kingston Hospital NHS Foundation Trust | Kingston | United Kingdom |
| Chelsea and Westminster Hospital | London | SW10 9NH | United Kingdom |
| Imperial College Healthcare NHS Trust | London | W6 8RF | 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 |
| Reset | Oct 18, 2024 |
| Release | Feb 5, 2025 |
| Reset | Feb 26, 2025 |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 17, 2024 | Jul 18, 2024 | |||
| Jul 18, 2024 | Oct 18, 2024 | |||
| Feb 5, 2025 | Feb 26, 2025 |
| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| D014571 | Urologic Neoplasms |
| D017060 | Patient Satisfaction |
| D010342 | Patient Acceptance of Health Care |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014570 | Urologic Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| C022673 | delta 24-sterol reductase |
Not provided
Not provided
Not provided