Prostate cancer Cancer Malignant neoplasm of prostate
Conditions
Interventions
Summary of design:
1. Study introduction and discussion
2. Return for study appointment (prior to next clinical follow up appointment).
2. Consent & randomisation to standard of care (SOC) or interv
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Men newly diagnosed with primary non-metastatic PCa 2. Men for whom either active surveillance or radical treatment (prostatectomy +/- radiotherapy) are felt to be appropriate by the diagnosing clinician 3. Age 35-80 years 4. Able to understand and sign the written Informed Consent Form
Exclusion criteria
Exclusion criteria: 1. Subject is known to have a condition, which affects their ability to see, read or understand the decision aid 2. Subject is known to have any other condition, which in the opinion of the investigator makes the subject unsuitable for study participation 3. The subject is unable to comprehend English. (PREDICT Prostate is only available in English currently)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient scores on decisional certainty measured by the decisional conflict scale at study appointment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient scores on state-anxiety measured on the State-Trait Anxiety Inventory (STAI-Y) at study appointment 2. Reported treatment preference and confidence in their decision on a 0-100 scale measured at study appointment 3. Actual treatment decided upon or received (as recorded in the medical notes) recorded up to 12 months after the study appointment | — |
Countries
England, United Kingdom
Outcome results
None listed