PROState Pathway Embedded Comparative Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 3
- 主要终点
- Number of Men Who Consented to Inclusion in PROSPECT Study Out of Total Number of Patients Approached
研究概览
简要总结
The proposal will explore a trial design called the cohort-multiple RCT (cmRCT) or as it has been recently coined, the Trials WithIn Cohorts (TWICS) design. This design has been used in a number of disease areas, both benign and cancer. Prostate conditions have been chosen since they are extremely common and if malignancy occurs the majority of men with the disease are regarded as living with a chronic condition due to its long natural history and in which innovative approaches, interventions, treatments or changes in management might have a significant patient benefit and impact on the NHS. It therefore fits the cmRCT design very well. Nonetheless, the lessons learned in this study will be of relevance to other disease spaces.
The TWICS or cmRCT design is currently being used in elderly patients, risk of falls, depression, hip fracture, Yorkshire Health Study, scleroderma, breast cancer, colorectal cancer, bladder cancer and kidney cancer, to name a few. In total, a recent systematic review showed that there were 18 ongoing cmRCT studies with 6 in the UK.
The acceptability and feasibility of the cmRCT in the prostate pathway will be tested. This is the first time this method will be tested and therefore piloted. In the first part of the study, the following will be evaluated. What is the accrual rate? What do patients and their healthcare professionals think of the cmRCT design? Is the data collected robust? What are the resource requirements of such a study?A number of novel interventions or changes in the pathway will then be tested and compared to standard care in the cohort that was recruited.
详细描述
TRIAL AIMS
The pilot phase of PROSPECT is interested in investigating the a) acceptability and feasibility of establishing the cohort of men, i.e. putting the questions of Point of Consent One to men being referred for investigation of prostate cancer, and b) observing the cohort over the study period and collecting data on the participants pertaining to their disease, their treatment and their health status.
A) Acceptability
AIM 1.1: To determine what proportion of men with a clinical suspicion for prostate cancer will participate in an cmRCT.
OBJECTIVE 1.1a: To evaluate proportion of patients approached who agree to participate in the longitudinal cohort. This will be done by calculating the participation rates from men approached for invitation to PROSPECT.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged 18 years old and over who are referred for investigations for urinary symptoms or elevated serum prostate specific antigen (PSA) levels or other risk factors for possible prostate malignancy.
- •An understanding of the English language sufficient to understand written and verbal information about the trial and consent process.
- •Estimated life expectancy of 5 years or more.
- •Signed informed consent.
排除标准
- •Men who are unable to give informed consent.
结局指标
主要结局
Number of Men Who Consented to Inclusion in PROSPECT Study Out of Total Number of Patients Approached
时间窗: from baseline to 23 months
Number of men who consented to inclusion in PROSPECT Study out of total number of patients approached at the original point of contact by the research team.
Number of Participants Approached for the Study From the Number of Patients Referred to the Study Team by Other Participating Centres
时间窗: from baseline to 23 months
Evaluation of the number of men approached to enter the PROSPECT Study from the number of men referred to the participating centres for investigation of prostate cancer.
Number of Participants Who Complete a Questionnaire on the Quality of Life (EQ5D-5L)
时间窗: Questionnaire was completed at baseline - 0 months, visit 1 - 6 months, visit 2 -12 months and visit 3 -18 months.
Number of Participants who complete a given standard Quality of Life Questionnaire (EQ5D-5L) at the point at which they consent to inclusion into PROSPECT. (Baseline Visit)
Number of Participants Who Complete a Questionnaire on Quality of Life (EPIC-26)
时间窗: Questionnaire was completed at baseline - 0 months, visit 1 - 6 months, visit 2 -12 months and visit 3 -18 months.
Number of Participants who completed a given standard Quality of Life Questionnaire (EPIC-26) at the point at which they consent to inclusion into PROSPECT. (Baseline Visit)
Number of Participants Who Complete a Questionnaire on Quality of Life (IPSS)
时间窗: Questionnaire was completed at baseline - 0 months, visit 1 - 6 months, visit 2 -12 months and visit 3 -18 months.
Number of Participants who complete a given standard Quality of Life Questionnaire (IPSS) at the point at which they consent to inclusion into PROSPECT.
Number of Participants Who Complete a Questionnaire on Quality of Life (IIEF-15)
时间窗: Questionnaire was completed at baseline - 0 months, visit 1 - 6 months, visit 2 -12 months and visit 3 -18 months.
Number of Participants who completed a given standard Quality of Life Questionnaire (IIEF-15) at the point at which they consent to inclusion into PROSPECT. (Baseline Visit)
次要结局
未报告次要终点