The Impact of an In-consultation Patient Decision Aid on Treatment Choices and Outcomes of Management for Patients With an Unexpected Malignant Colorectal Polyp A Non-randomized Clinical Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 110
- 主要终点
- Number of patients undergoing completion surgery of an unexpected malignant polyp compared to historical data.
研究概览
简要总结
Management of unexpected malignant colorectal polyps removed endoscopically can be challenging due to the risk of residual tumor and lymphatic spread. International studies have shown that in patients choosing surgical management instead of watchful waiting, 54-82% of bowel resections are without evidence of residual tumor or lymphatic spread. As surgical management entails risks of complications and watchful waiting management entails risks of residual disease or recurrence, a clinical dilemma arises when choosing a management strategy.
Shared decision making (SDM) is a concept that can be used in preference sensitive decision making to facilitate patient involvement, empowerment, and active participation in the decision making process.
This is a clinical multicenter, non-randomized, interventional phase II study involving Danish surgical departments planned to commence in the first quarter of 2024. The aim of the study is to examine whether shared decision making and using a patient decision aid (PtDA) in consultations affects patients' choice of management compared with historical data. The secondary aim is to investigate Patient Reported Experience Measures (PREMs) and Patient Reported Outcome Measures (PROMs) using questionnaire feedback directly from the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologically verified malignant colorectal polyp removed endoscopically and CT-scan (and MRI if the malignant polyp was situated in the rectum) shows N0, M0 disease.
排除标准
- •Inability to provide informed consent
- •Inoperable due to comorbidity
- •Known residual tumor left in situ after local resection, >N0 or >M0
结局指标
主要结局
Number of patients undergoing completion surgery of an unexpected malignant polyp compared to historical data.
时间窗: 30 days
次要结局
- Quality of life as measured by the the European Organization for Research and Treatment of Cancer Quality of Life questionnaire.(24 hours after clinical encounter)
- Number of patients with recurrence 3 years after cancer diagnosis(3 years)
- Number of patients with postoperative mortality 90 days after surgery(90 days postoperatively)
- Rate of patients with an unexpected malignant polyp undergoing completion surgery without residual tumor or lymph node metastases compared to historical data.(45 days)
- Number of patients with postoperative morbidity 30 days after surgery(30 days postoperatively)
- Number of patients with postoperative morbidity 90 days after surgery(90 days postoperatively)
- Overall survival 3 years after cancer diagnosis(3 years)
- Number of patients with postoperative mortality 30 days after surgery(30 days postoperatively)
- Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life questionnaire.(6 months after clinical encounter)