[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603342":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":70,"studyPopulation":64,"armGroups":71,"interventions":84,"overallOfficials":93,"centralContacts":97,"locations":64,"responsibleParty":106,"collaborators":64,"id":108,"slug":64,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":109,"sex":115,"minAge":64,"maxAge":64,"enrollmentInfo":116,"targetDuration":64,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":129,"whyStopped":64,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":64},{"fullName":5,"class":6},"University College, London","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":50},[9],{"measure":10,"description":11,"timeFrame":12},"Decisional Conflict Scale (DCS)","Mean difference in DCS between control (SOC) arm and intervention (Bespoke Decision Support) groups.\n\nScores 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.",[14,17,20,24,27,31,35,39,42,46],{"measure":15,"description":16,"timeFrame":12},"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\\].",{"measure":18,"description":19,"timeFrame":12},"Decision Self Efficacy (DSE) Scale","Mean difference in the DSE score between the control and the intervention groups.\n\nScores range from 0 \\[not at all confident\\] to 100 \\[very confident\\].",{"measure":21,"description":22,"timeFrame":23},"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.",{"measure":25,"description":26,"timeFrame":23},"Decision Regret Scale (DRS)","Mean difference in the DRS score between the control and the intervention groups.\n\nScores range from 0 \\[no regret\\] to 100 \\[high regret\\].",{"measure":28,"description":29,"timeFrame":30},"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.\n\nScores for the sub-scale \"Satisfaction with the amount and content of information\" range from 1 to 14 (14=higher satisfaction).\n\nScores 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.",{"measure":32,"description":33,"timeFrame":34},"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).",{"measure":36,"description":37,"timeFrame":38},"Hospital Anxiety and Depression Scale (HADS)","Frequencies and proportion of the HADS categories in both the intervention and the control group.\n\nScores 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.",{"measure":40,"description":41,"timeFrame":12},"Decisional Conflict Scale (DCS) Subscales","Means or medians of the intervention and the control groups for the different DCS sub-scores:\n\n* Informed sub-score (Scores range from 0 \\[feels extremely informed\\] to 100 \\[feels extremely uninformed\\]);\n* Values Clarity sub-score(Scores range from 0 \\[feels extremely clear about personal values for benefits \\& risk\u002Fside effects\\] to 100 \\[feels extremely unclear about personal values\\]);\n* Support sub-score (Scores range from 0 \\[ feels extremely supported in decision making\\] to 100 \\[feels extremely unsupported in decision making\\]);\n* Uncertainty sub-score (Scores range from 0 \\[feels extremely certain about best choice\\] to 100 \\[feels extremely uncertain about best choice\\]);\n* Effective Decision sub-score (Scores range from 0 \\[good decision\\] to 100 \\[bad decision\\]).",{"measure":43,"description":44,"timeFrame":45},"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)",{"measure":47,"description":48,"timeFrame":49},"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",[51,55,58],{"measure":52,"description":53,"timeFrame":54},"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.",{"measure":56,"description":57,"timeFrame":54},"Treatment choice","Proportion of different treatments chosen (active surveillance, focal therapy, radical prostatectomy and radiotherapy) between the intervention and the control groups.",{"measure":59,"description":60,"timeFrame":54},"Time to treatment decision","Time passed between enrolment and recording of treatment decision between the control and intervention group.",{"allocation":62,"interventionModel":63,"interventionModelDescription":64,"primaryPurpose":65,"observationalModel":64,"timePerspective":64,"maskingInfo":66},"RANDOMIZED","PARALLEL",null,"SUPPORTIVE_CARE",{"masking":67,"maskingDescription":64,"whoMasked":68},"SINGLE",[69],"PARTICIPANT","Recruited patient participants will be randomised into two arms:\n\n* Standard of Care (SOC) arm: SOC counselling\n* Intervention arm: SOC counselling plus access to BeSpoke Decision Support\n\nThe 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.\n\nThe intervention arm will offer additional BeSpoke Decision Support providing:\n\n* Consistent and up-to-date information about suitable treatment approaches.\n* Risk-stratified predictions of treatment outcomes based on baseline cancer and patient characteristics.\n* Value clarification about which attributes of treatment are most important to the individual.\n\nAll 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.\n\nThe 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.",[72,78],{"label":73,"type":74,"description":75,"interventionNames":76},"Standard of Care (SOC)","PLACEBO_COMPARATOR","Standard of Care Counselling information",[77],"Other: Standard of Care (SOC) decision support material",{"label":79,"type":80,"description":81,"interventionNames":82},"BeSpoke Decision Support","EXPERIMENTAL","Standard of care counselling plus access to BeSpoke Decision Support tool",[83,77],"Other: Bespoke Decision Support tool",[85,89],{"type":6,"name":86,"description":87,"armGroupLabels":88,"otherNames":64},"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.",[79],{"type":6,"name":90,"description":91,"armGroupLabels":92,"otherNames":64},"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.",[79,73],[94],{"name":95,"affiliation":5,"role":96},"Caroline M Moore, MD","PRINCIPAL_INVESTIGATOR",[98,103],{"name":99,"role":100,"phone":101,"phoneExt":64,"email":102},"Davide Maffei, MD","CONTACT","+44 (0)20 7679 2000","d.maffei@ucl.ac.uk",{"name":104,"role":100,"phone":64,"phoneExt":64,"email":105},"NCITA Clinical Trial Unit","ncita.bespoke@ucl.ac.uk",{"type":107,"investigatorFullName":64,"investigatorTitle":64,"investigatorAffiliation":64,"oldNameTitle":64,"oldOrganization":64},"SPONSOR","100603342",false,"NCT07135271","BeSpoke Decision Support for Patients With Newly Diagnosed Localised Prostate Cancer","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","BeSpoke","Inclusion Criteria for Patient-Participants:\n\n1. Newly diagnosed localised prostate cancer\n2. Clinically suitable for at least two of the following treatment options:\n\n   1. active surveillance\n   2. focal therapy\n   3. radical prostatectomy\n   4. external beam radiotherapy\n3. Willing and able to provide informed consent\n\nExclusion Criteria for Patient Participants:\n\n1. Unsuitable for active treatment due to very low risk prostate cancer or significant health issues.\n2. Suspicion of metastatic prostate cancer based on clinical or imaging evidence including:\n\n   1. Imaging identified suspicious lesion on bone scan, CT, whole-body MRI or PSMA-PET\u002FCT;\n   2. PSA ≥50 ng\u002FmL.\n3. Not able to provide informed consent.\n4. 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.)\n5. 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)\n\nInclusion criteria for Health Care Professionals:\n\n1. Have seen BeSpoke Decision Support and spoken to patients in the intervention arm.\n2. Willing and able to provide written or electronic informed consent\n\nExclusion criteria for Health Care Professionals\n\n1\\. No experience of BeSpoke Decision Support.","ALL",{"count":117,"type":118},346,"ESTIMATED","INTERVENTIONAL",[121],"NA","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:\n\n• Does the Bespoke Decision Support tool reduce decisional conflict in those choosing between treatment options for localised prostate cancer?\n\nResearchers will compare the addition of the Bespoke Decision Support tool to standard treatment counselling versus standard counselling alone.\n\nPatient participants will:\n\n* Receive standard counselling with or without access to the Bespoke Decision Support tool (based on arm of randomisation), prior to making a treatment decision.\n* 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.\n* Take part in a qualitative interview to discuss their decision-making experience\n\nHealth Care Professional participants will:\n\n• Take part in a qualitative interview to discuss their experience in providing decision support in the trial using the Bespoke Decision Support tool.",[124],"Localised Prostate Cancer",[124,126,127,128],"Patient Decision Aid","Shared Decision Making","Randomised Clinical Trial","NOT_YET_RECRUITING","2026-06-09",{"date":132,"type":133},"2026-06-10","ACTUAL",{"date":135,"type":118},"2026-06",{"date":137,"type":118},"2028-12",{"name":5,"class":6}]