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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 346
- 试验地点
- 1
- 主要终点
- Decisional Conflict Scale (DCS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Standard of Care (SOC)
Standard of Care Counselling information
干预措施: Standard of Care (SOC) decision support material (Other)
BeSpoke Decision Support
Standard of care counselling plus access to BeSpoke Decision Support tool
干预措施: Bespoke Decision Support tool (Other)
BeSpoke Decision Support
Standard of care counselling plus access to BeSpoke Decision Support tool
干预措施: Standard of Care (SOC) decision support material (Other)
结局指标
主要结局
Decisional Conflict Scale (DCS)
时间窗: After treatment decision is confirmed, assessed as patient-reported outcome measure via questionnaire delivered on average after 4 weeks from enrolment.
Mean difference in DCS between control (SOC) arm and intervention (Bespoke Decision Support) groups. Scores range from 0 \[no decisional conflict\] to 100 \[extremely high decisional conflict\].
次要结局
- 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.)
- Control Preference Scale (CPS)(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)(Measured before giving intervention, and after 3, 6 and 12 months from treatment initiation.)
- Decisional Conflict Scale (DCS) Subscales(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(Between treatment decision being recorded and end of study (12 months after treatment initiation))
- Qualitative assessment with Health Care Professionals (HCP)(Through study completion, an average of 1 year)