CompletedNot Applicable

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

Spain846 participantsStarted 2021-02-19

Plain-language summary

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.

Who can participate

Age range

49 Years – 69 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Perception of Shared Decision Making

Timeframe: 2 months

Trial details

NCT IDNCT04610086

SponsorCorporacion Parc Tauli

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-06-30

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