Ignite Creation Date:
2025-12-18 @ 8:44 AM
Ignite Modification Date:
2025-12-18 @ 8:44 AM
Study NCT ID:
NCT07135271
Status:
None
Last Update Posted:
2025-08-22 00:00:00
First Post:
2025-08-11 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BeSpoke Decision Support for Patients With Newly Diagnosed Localised Prostate Cancer
Sponsor:
None
Organization:
Study Overview
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
Status:
None
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BeSpoke
Brief Summary:
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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: