IP5-MATTER: Metastatic Prostate Cancer Men's Attitudes Towards Treatment of the Local Tumour and Metastasis Evaluative Research
Study Details
Study Description
Brief Summary
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'.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Other: 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 |
Other: 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. |
Other: Think Aloud Interview Patients
Interview
|
| Stage 3 (n = 300) Intervention: Single, Discrete Choice Experiment Questionnaire at Enrollment Visit |
Other: Discrete Choice Experiment (DCE) Patients
DCE Questionnaire
|
Outcome Measures
Primary Outcome Measures
- Treatment attribute preferences as assessed using a study-specific think aloud interview. [Through study completion, an average of 3 months [Stage 2] (Think Aloud Interview).]
Qualitative work derived from "Think Aloud Interviews". Treatments include radiotherapy, surgery, ablation and metastasis directed therapy.
- 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 [Stage 3] (Discrete Choice Experiment (DCE) Questionnaire). Trade-off from Marginal Rate of Substitution calculate as percentage points (0 to 100).]
Utility values obtained via multinominal logit estimates from discrete choice experiment
Secondary Outcome Measures
- Willingness to accept the potential effect sizes that are shown in trials. [Through study completion, an average of 1 year [Stage 3] (Discrete Choice Experiment (DCE) Questionnaire). No scale.]
Derived from discrete choice experiment finding analysed alongside reported outcomes from ongoing therapeutic trials.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosed with prostate cancer within 4 months of screening visit
-
Performance status 0-2
Exclusion Criteria:
-
Castrate-resistant metastatic prostate cancer
-
Patient has consented to a form of local cytoreductive treatment to prostate
-
Patient has consented to a form of metastasis directed therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Besti Cadwaladr University | Bangor | United Kingdom | ||
| 2 | Frimley Health Nhs Foundation Trust | Frimley | United Kingdom | ||
| 3 | Imperial College London | Hammersmith | United Kingdom | ||
| 4 | West Middlesex University Hospital | Isleworth | United Kingdom | TW7 6AF | |
| 5 | Queen Elizabeth Hospital | King's Lynn | United Kingdom | PE30 4ET | |
| 6 | Chelsea and Westminster Hospital | London | United Kingdom | SW10 9NH | |
| 7 | Imperial College Healthcare NHS Trust | London | United Kingdom | W6 8RF | |
| 8 | Guy's and St Thomas Hospital, Guy's and St Thomas' NHS Foundation Trust | London | United Kingdom | ||
| 9 | The Royal Marsden NHS Foundation Trust, Chelsea Research Centre | London | United Kingdom | ||
| 10 | Freeman Hospital, Newcastle, Newcastle upon Tyne Hospitals NHS Foundation Trust | Newcastle Upon Tyne | United Kingdom | ||
| 11 | Southampton General Hospital, University Hospital Southampton NHS Foundation Trust (UHS) | Southampton | United Kingdom | ||
| 12 | East and North Hertfordshire Nhs Trust | Stevenage | United Kingdom | ||
| 13 | Sunderland Royal Hospital, City Hospitals Sunderland NHS Foundation Trust | Sunderland | United Kingdom | ||
| 14 | The Clatterbridge Cancer Centre Nhs Foundation Trust | Wirral | United Kingdom | ||
| 15 | Wirral University Teaching Hospital Nhs Foundation | Wirral | United Kingdom |
Sponsors and Collaborators
- Imperial College London
- University of Aberdeen
Investigators
- Principal Investigator: Hashim Ahmed, PhD, FRCS, Imperial College London
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 276834