NCT07135271

BeSpoke Decision Support for Patients With Newly Diagnosed Localised Prostate Cancer

Building and Evaluating a Stratified Prostate Cancer Pathway (BeSpoke): the Impact of BeSpoke Decision Support in Patients With Newly Diagnosed Localised Prostate Cancer - a Single-blind Randomised Controlled Trial With Mixed Method Analysis

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 346 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Recruited patient participants will be randomised into two arms: * Standard of Care (SOC) arm: SOC counselling * Intervention arm: SOC counselling plus access to BeSpoke Decision Support The standard of care (SOC) arm includes the nationally-approved Prostate Cancer UK booklet "Prostate Cancer - A guide if you have recently been diagnosed" and patient appointments to discuss different treatments with clinicians, as per local practice that offer them. Further educational material may be provided as per local practice at each site. The intervention arm will offer additional BeSpoke Decision Support providing: * Consistent and up-to-date information about suitable treatment approaches. * Risk-stratified predictions of treatment outcomes based on baseline cancer and patient characteristics. * Value clarification about which attributes of treatment are most important to the individual. All participants will complete questionnaires on demographic data, functional status and measures of decision-making experiences at several time points: enrolment (prior to treatment discussion consultation); after treatment decision has taken place; at 3, 6, and 12 months after treatment commences. The investigators will interview health care professionals and a sample of patient participants to assess the effect of the BeSpoke Decision Support and the challenges in implementation across the NHS.

Conditions

• Localised Prostate Cancer

Interventions

Type	Name	Description
OTHER	Bespoke Decision Support tool	A 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.
OTHER	Standard of Care (SOC) decision support material	Standard 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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-11-01
• Completion: 2028-06-01
• First posted: 2025-08-22
• Last updated: 2025-08-22