Shared Decision Making and Satisfaction With the Diagnostic-therapeutic Process in the Shared Decision Making and Satisfaction With Colorectal Cancer Screening. The CyDESA Study

Study Overview
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Brief Summary
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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.

Official Title
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Shared Decision Making and Satisfaction With the Diagnostic-therapeutic Process in the Context of the Colorectal Cancer Screening Program. The CyDESA Study.

Conditions
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Colorectal Cancer, Satisfaction, Patient

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 49 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| False positive FIT<br>Participants in the colorectal cancer screening program, with a positive FIT and with a normal colonoscopy | |
| Polyps<br>Participants in the colorectal cancer screening program, with a positive FIT and diagnosed of colorectal polyps in the colonoscopy | |
| Colorectal cancer<br>Participants in the colorectal cancer screening program, with a positive FIT diagnosed by colorectal cancer | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction | Satisfaction with the colorectal cancer screening programm | Once the screening process is finished | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participation in decision making | Patient perception of participation in decision making during the screening process | Once the screening process is finished | 
| Satisfaction with diagnosis and treatment of cancer | Satisfaction with the diagnostic and treatment processess of cancer | at 6 months | 
| Participation in cancer decision making | Patient perception about participation in decision making during the diagnostic and treatment processess of cancer | at 6 months |