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临床试验/NCT04938336
NCT04938336已完成不适用

Evaluation of a Decision Aid Tool in Rectal Cancer patiënts

University Hospital, Ghent2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年4月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Assessment of accuracy of the decision aid tool trough a delphi procedure

研究概览

简要总结

Adapt and evaluate a decision aid for patients with rectal cancer. Phase 1 : decision aid testing (Delphi) multicentric Phase 2: pilot test decision aid

详细描述

Adapt and evaluate a decision aid for patients with rectal cancer. Phase1: decision aid testing (Delphi) A pilot version of the Belgian decision aid was developed and validated through a double Delphi procedure. In this study, the assessment is extended to several multicentre experts. The panel consists of ten experts who have extensive knowledge in the field of rectal cancer or scientific research. They are asked to evaluate the information and questions on accuracy, clarity, readability and relevance. They score the items of the decision aid using a 4-point Likert-type scale (one (one = totally irrelevant; four = very relevant) and a dichotomous scale (one = clear, two = not clear) to assess relevance and clarity of wording, respectively (see Appendix 2 to this application). To quantify the degree of content validity, the Content Validity Index (CVI) is used.

Phase2: pilot test decision aid The final step of the study is a pilot test of the decision aid with patients who will undergo surgery/watch and wait strategy in the near future and with healthcare professionals who work with the decision aid. The aim is to test the acceptability of the decision aid with the patient and the ease of use with the healthcare professional. With the feedback from the patients and the healthcare professional, the decision aid can be further refined.

During the consultation in which the intervention is discussed, the consent to participate will be asked of the patient and also of the informal carer who may be present at that moment. Participation in the study means that during this consultation, the caregiver involved will go through the decision aid completely with the patient and any informal carer. After the intervention, they will be asked to give feedback on their experiences with the use of the decision aid. This will be done by means of an interview for the patients, informal carers and care workers involved. The interview with the patient (and informal carer if applicable) will take place at home or in the hospital, depending on their preference. The interview with the caregiver takes place in the hospital where the caregiver works. If the current Covid-19 pandemic does not allow for a visit to the patient's home or to another hospital, the interviews will be conducted by telephone or video call.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • expert healthcare professionals caring for patients with rectal cancer

排除标准

  • Interviews Inclusion criteria
  • Patients in which the decision aid was tested
  • patients with a tumor in the last 10cm of the rectum
  • healthcare professionals who have used the decision aid tool
  • informal carer indicated by the patient Exclusion
  • patients who have no treatment choice due to oncological reasons

结局指标

主要结局

Assessment of accuracy of the decision aid tool trough a delphi procedure

时间窗: 2-3 months (until consensus)

Assessment of accuracy of the decision aid tool through a delphi procedure

Assessment of clarity of the decision aid tool trough a delphi procedure

时间窗: 2-3 months (until consensus)

Assessment of clarity of the decision aid tool trough a delphi procedure

Assessment of readability of the decision aid tool trough a delphi procedure

时间窗: 2-3 months (until consensus)

Assessment of readability of the decision aid tool trough a delphi procedure

Assessment of relevance of the decision aid tool trough a delphi procedure

时间窗: 2-3 months (until consensus)

Assessment of relevance of the decision aid tool trough a delphi procedure

Assessment of the usability of the decision aid tool through individual interviews

时间窗: about 60 minutes

Assessment of the usability of the decision aid tool through individual interviews

Assessment of the acceptability of the decision aid tool through individual interview

时间窗: about 60 minutes

Assessment of the acceptability of the decision aid tool through individual interview

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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