BeSpoke Decision Support for Patients With Newly Diagnosed Localised Prostate Cancer

Official title

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

Overview

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.

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.

Primary outcome measures

• Decisional Conflict Scale (DCS) [Time frame: After treatment decision is confirmed, assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment.]

Secondary outcome measures (10)

• Preparation for Decision Making (PrepDM) Scale [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: 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 [Time frame: 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.]
• Control Preference Scale (CPS) [Time frame: Measured at enrolment and after treatment decision is confirmed (assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment).]
• Hospital Anxiety and Depression Scale (HADS) [Time frame: Measured before giving intervention, and after 3, 6 and 12 months from treatment initiation.]
• Decisional Conflict Scale (DCS) Subscales [Time frame: After treatment decision is confirmed, assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment.]
• Qualitative Assessment with Patients [Time frame: Between treatment decision being recorded and end of study (12 months after treatment initiation)]
• Qualitative assessment with Health Care Professionals (HCP) [Time frame: Through study completion, an average of 1 year]

Eligibility criteria

Inclusion Criteria for Patient-Participants:

• 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

Exclusion Criteria for Patient Participants:

• 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)

Inclusion criteria for Health Care Professionals:

• Have seen BeSpoke Decision Support and spoken to patients in the intervention arm.
• Willing and able to provide written or electronic informed consent

Exclusion criteria for Health Care Professionals

1\. No experience of BeSpoke Decision Support.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

United Kingdom · 1 center

• University College London Hospitals NHS Foundation Trust — London

Identifiers

NCT: NCT07135271 · 176848 · IRAS 347220 · 25/LO/0394

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗