BeSpoke Decision Support for Patients With Newly Diagnosed Localised Prostate Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity College, London

About this trial

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.

Eligibility criteria

Qualifiers

Newly diagnosed localised prostate cancer

active surveillance

focal therapy

radical prostatectomy

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Bespoke Decision Support tool
  • Standard of Care (SOC) decision support material

Treatment groups

346 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators