Shared Decision Making and Satisfaction With the Diagnostic-therapeutic Process in the Context of the Colorectal Cancer Screening Program. The CyDESA Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 846
- 试验地点
- 2
- 主要终点
- Satisfaction
研究概览
简要总结
A cross sectional multicenter study (3 centers) to know the participation in decision making and the experience and satisfaction of participants with a positive immunological fecal test (FIT) result in relation to the screening process and the diagnostic-therapeutic process of cancer.
We will include 850 participants with a positive FIT result and will classify them by their final diagnosis (false positives of FIT; polyps; colo-rectal cancer).
Outcomes of interest will be measured by auto administered questionnaires:
collaboRATE, SDM-Q-9, OUT-PATSAT35 and a satisfaction questionnaire developed in a previous study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 49 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants in the colorectal cancer screening program, with a positive result in the FIT AND in whom the perform of a colonoscopy is indicated AND agree to be included
排除标准
- •People for whom the performance of a colonoscopy is not indicated by medical reasons
- •People who refuse to perform a colonoscopy
- •People who do not understand Spanish or Catalan, with deterioration of the cognitive state that do not allow them to understand or answer the questionnaires on their own or with the help of a caregiver;
- •People in which the process is not carried out completely in the study centers (eg. performance of the colonoscopy in a private center).
研究组 & 干预措施
False positive FIT
Participants in the colorectal cancer screening program, with a positive FIT and with a normal colonoscopy
Polyps
Participants in the colorectal cancer screening program, with a positive FIT and diagnosed of colorectal polyps in the colonoscopy
Colorectal cancer
Participants in the colorectal cancer screening program, with a positive FIT diagnosed by colorectal cancer
结局指标
主要结局
Satisfaction
时间窗: Once the screening process is finished
Satisfaction with the colorectal cancer screening programm
Perception of Shared Decision Making
时间窗: 2 months
Perception of participants of shared decision making
次要结局
- Participation in cancer decision making(at 6 months)
- Participation in decision making(Once the screening process is finished)
- Satisfaction with diagnosis and treatment of cancer(at 6 months)
- Satisfaction with the screening process(2 months)
研究者
Anna Selva
Medical Doctor
Corporacion Parc Tauli