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| ID | Type | Description | Link |
|---|---|---|---|
| IRAS 347220 | Other Identifier | NHS Health Research Authority | |
| 25/LO/0394 | Other Identifier | London - Fulham Research Ethics Committee |
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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:
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.
Recruited patient participants will be randomised into two arms:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care (SOC) | Placebo Comparator | Standard of Care Counselling information |
|
| BeSpoke Decision Support | Experimental | Standard of care counselling plus access to BeSpoke Decision Support tool |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Preparation for Decision Making (PrepDM) Scale | Mean difference in PrepDM Scale between control and intervention group. Scores range from 0 to 100 [higher scores indicate higher perceived level of preparation for decision making]. | After treatment decision is confirmed, assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment counselling consultations | Mean or median difference in number of treatment counselling consultations taking place between enrolment and treatment decision between the control and intervention group. | From date of randomisation until the date of first documented recording of treatment decision, assessed up to 12 months. |
Inclusion Criteria for Patient-Participants:
Newly diagnosed localised prostate cancer
Clinically suitable for at least two of the following treatment options:
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:
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:
Exclusion criteria for Health Care Professionals
1. No experience of BeSpoke Decision Support.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Davide Maffei, MD | Contact | +44 (0)20 7679 2000 | d.maffei@ucl.ac.uk | |
| NCITA Clinical Trial Unit | Contact | ncita.bespoke@ucl.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Caroline M Moore, MD | University College, London | Principal Investigator |
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| Label | URL |
|---|---|
| Prostate Cancer: A guide if you've just been diagnosed - Prostate Cancer UK | View source |
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Any request to share IPD from other researchers will be evaluated by the Trial Steering Committee on an ad hoc basis.
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| 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. |
|
| Decision Self Efficacy (DSE) Scale | Mean difference in the DSE score between the control and the intervention groups. Scores range from 0 [not at all confident] to 100 [very confident]. | 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 | Mean difference in the SWD score between the control and the intervention groups. Scores range from 1 to 5 (5=higher satisfaction). | 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) | Mean difference in the DRS score between the control and the intervention groups. Scores range from 0 [no regret] to 100 [high regret]. | 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 | Mean difference in the SCIP score between the control and the intervention groups at time-point 1 and time-point 4. Scores for the sub-scale "Satisfaction with the amount and content of information" range from 1 to 14 (14=higher satisfaction). Scores for the sub-scale "Satisfaction with the form and timing of information" range from 7 (lower satisfaction) to 35 (higher satisfaction). | 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) | Frequencies and proportion of the CPS categories in both the intervention and the control group. | 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) | Frequencies and proportion of the HADS categories in both the intervention and the control group. Scores range from 0 to 21: 0-7 = Normal; 8-10 = Borderline abnormal (borderline case); 11-21 = Abnormal (case). | Measured before giving intervention, and after 3, 6 and 12 months from treatment initiation. |
| Decisional Conflict Scale (DCS) Subscales | Means or medians of the intervention and the control groups for the different DCS sub-scores:
| 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 | Qualitative interview evaluating patient experience in treatment decision making and feedback on decision support material | Between treatment decision being recorded and end of study (12 months after treatment initiation) |
| Qualitative assessment with Health Care Professionals (HCP) | Qualitative interviews with HCP (urologists, clinical oncologists, clinical nurse specialists, GPs) involved in the treatment decision making pathway of patients with prostate cancer, to inquire regarding the decision support material provided as standard of care and in the intervention arm. | Through study completion, an average of 1 year |
| Treatment choice |
Proportion of different treatments chosen (active surveillance, focal therapy, radical prostatectomy and radiotherapy) between the intervention and the control groups. |
| From date of randomisation until the date of first documented recording of treatment decision, assessed up to 12 months. |
| Time to treatment decision | Time passed between enrolment and recording of treatment decision between the control and intervention group. | From date of randomisation until the date of first documented recording of treatment decision, assessed up to 12 months. |