The goal of this randomised clinical trial is to assess whether personalised treatment counselling can improve the decision-making experience in patients with a new diagnosis of localised prostate cancer. The main question it aims to answer is:
• Does the Bespoke Decision Support tool reduce decisional conflict in those choosing between treatment options for localised prostate cancer?
Researchers will compare the addition of the Bespoke Decision Support tool to standard treatment counselling versus standard counselling alone.
Patient participants will:
* Receive standard counselling with or without access to the Bespoke Decision Support tool (based on arm of randomisation), prior to making a treatment decision. * Answer to questionnaires regarding urinary, sexual and bowel function and decision-making outcomes before and after making a treatment decision and at 3, 6, and 12 months after initiating treatment. * Take part in a qualitative interview to discuss their decision-making experience
Health Care Professional participants will:
• Take part in a qualitative interview to discuss their experience in providing decision support in the trial using the Bespoke Decision Support tool.
Newly diagnosed localised prostate cancer
active surveillance
focal therapy
radical prostatectomy
Unsuitable for active treatment due to very low risk prostate cancer or significant health issues.
Imaging identified suspicious lesion on bone scan, CT, whole-body MRI or PSMA-PET/CT;
PSA ≥50 ng/mL.
Not able to provide informed consent.
Parallel
Bespoke Decision Support tool
Other interventionA newly-developed online patient decision aid offering comparative information of prostate cancer treatments (active surveillance, focal therapy, radical prostatectomy and external beam radiotherapy), personalised estimates of oncological and functional outcomes for each treatment and a value-clarification exercise.
Standard of Care (SOC) decision support material
Other interventionStandard of care information to inform the prostate cancer treatment decision. This includes the nationally approved Prostate Cancer UK information booklet "Prostate Cancer - A guide if you have just been diagnosed" in all sites. Further educational material may be provided as part of standard of care depending on local practice at each site.
Decisional Conflict Scale (DCS)
Mean difference in DCS between control (SOC) arm and intervention (Bespoke Decision Support) groups. Scores range from 0 \[no decisional conflict\] to 100 \[extremely high decisional conflict\].
Preparation for Decision Making (PrepDM) Scale
Mean difference in PrepDM Scale between control and intervention group. Scores range from 0 to 100 \[higher scores indicate higher perceived level of preparation for decision making\].
Decision Self Efficacy (DSE) Scale
Mean difference in the DSE score between the control and the intervention groups. Scores range from 0 \[not at all confident\] to 100 \[very confident\].
Satisfaction With Decision (SWD) Scale
Mean difference in the SWD score between the control and the intervention groups. Scores range from 1 to 5 (5=higher satisfaction).
Decision Regret Scale (DRS)
Mean difference in the DRS score between the control and the intervention groups. Scores range from 0 \[no regret\] to 100 \[high regret\].
Number of treatment counselling consultations
Mean or median difference in number of treatment counselling consultations taking place between enrolment and treatment decision between the control and intervention group.
Treatment choice
Proportion of different treatments chosen (active surveillance, focal therapy, radical prostatectomy and radiotherapy) between the intervention and the control groups.
Time to treatment decision
Time passed between enrolment and recording of treatment decision between the control and intervention group.
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