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BeSpoke Decision Support for Patients With Newly Diagnosed Localised Prostate Cancer

NCT07135271 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 346

Last updated 2025-08-22

No results posted yet for this study

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.

Conditions

  • Localised Prostate Cancer

Interventions

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.

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Caroline M Moore, MD · University College, London

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2026-11-30
Completion
2028-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07135271 on ClinicalTrials.gov