BeSpoke Decision Support for Patients With Newly Diagnosed Localised Prostate Cancer

NCT07135271 | Not Yet Recruiting

• 3 other identifiers: 176848IRAS 34722025/LO/0394
• Study Type: interventional
• Target: 346
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Localised Prostate Cancer; Patient Decision Aid; Shared Decision Making; Randomised Clinical Trial

Outcome Measures

Primary Outcomes (1)

• 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 \[extremely high decisional conflict\].

  After treatment decision is confirmed, assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment.

Secondary Outcomes (10)

• Preparation for Decision Making (PrepDM) Scale

  After treatment decision is confirmed, assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment.

• Decision Self Efficacy (DSE) Scale

  After treatment decision is confirmed, assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment.

• Satisfaction With Decision (SWD) Scale

  Measured at multiple time points: after treatment decision is confirmed (assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment); and at 3, 6 and 12 months from the treatment date.

• Decision Regret Scale (DRS)

  Measured at multiple time points: after treatment decision is confirmed (assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment); and at 3, 6 and 12 months from the treatment date.

• Satisfaction with Cancer Information Profile (SCIP) Scale

  Measured after treatment decision is confirmed (assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment) and at 12 months after treatment initiation.

Other Outcomes (3)

• Number of treatment counselling consultations

  From date of randomisation until the date of first documented recording of treatment decision, assessed up to 12 months.

• Treatment choice

  From date of randomisation until the date of first documented recording of treatment decision, assessed up to 12 months.

• Time to treatment decision

  From date of randomisation until the date of first documented recording of treatment decision, assessed up to 12 months.

Study Arms (2)

Standard of Care (SOC)

PLACEBO COMPARATOR

Standard of Care Counselling information

Other: Standard of Care (SOC) decision support material

BeSpoke Decision Support

EXPERIMENTAL

Standard of care counselling plus access to BeSpoke Decision Support tool

Other: Bespoke Decision Support tool; Other: Standard of Care (SOC) decision support material

Interventions

Bespoke Decision Support tool OTHER

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.

BeSpoke Decision Support

Standard of Care (SOC) decision support material OTHER

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.

BeSpoke Decision Support; Standard of Care (SOC)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed localised prostate cancer
• Clinically suitable for at least two of the following treatment options:
• active surveillance
• focal therapy
• radical prostatectomy
• external beam radiotherapy
• Willing and able to provide informed consent

You may not qualify if:

• Unsuitable for active treatment due to very low risk prostate cancer or significant health issues.
• Suspicion of metastatic prostate cancer based on clinical or imaging evidence including:
• 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.
• Insufficient English proficiency for adequate use of BeSpoke Decision Support. (Patients with support from a family member, friend or partner, to overcome lack of English proficiency will be included.)
• Enrolled in other localised prostate cancer studies where treatment is assigned rather than chosen by participants, e.g. PART Trial (Partial prostate Ablation vs Radical prostaTectomy)
• Have seen BeSpoke Decision Support and spoken to patients in the intervention arm.
• Willing and able to provide written or electronic informed consent
• \. No experience of BeSpoke Decision Support.

Sponsors & Collaborators

• University College, London: lead

Related Links

• Prostate Cancer: A guide if you've just been diagnosed - Prostate Cancer UK

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Caroline M Moore, MD

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Davide Maffei, MD

CONTACT

+44 (0)20 7679 2000; d.maffei@ucl.ac.uk

NCITA Clinical Trial Unit

CONTACT

ncita.bespoke@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 22, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share