Health Care Utilization, Patient Satisfaction, Prostate Cancer Metastatic, Quality of Life, Radiotherapy Side Effect, Surgery, Urologic Cancer
Conditions
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'.
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.
Interventions
OTHERSemi-Structured Interview Healthcare Professional
Interview
OTHERSemi-Structured Interview Patients
Interview
OTHERThink Aloud Interview Patients
Interview
OTHERDiscrete Choice Experiment (DCE) Patients
DCE Questionnaire
Sponsors
University of Aberdeen
Imperial College London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with prostate cancer within 4 months of screening visit 2. Performance status 0-2
Exclusion criteria
1. Castrate-resistant metastatic prostate cancer 2. Patient has consented to a form of local cytoreductive treatment to prostate 3. Patient has consented to a form of metastasis directed therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United Kingdom
Outcome results
None listed