Shared Decision Making and Satisfaction With the Diagnostic-therapeutic Process in the Shared Decision Making and Satisfaction With Colorectal Cancer Screening. The CyDESA Study
NCT ID: NCT04610086
Last Updated: 2021-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
850 participants
OBSERVATIONAL
2020-11-19
2023-12-19
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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False positive FIT
Participants in the colorectal cancer screening program, with a positive FIT and with a normal colonoscopy
No interventions assigned to this group
Polyps
Participants in the colorectal cancer screening program, with a positive FIT and diagnosed of colorectal polyps in the colonoscopy
No interventions assigned to this group
Colorectal cancer
Participants in the colorectal cancer screening program, with a positive FIT diagnosed by colorectal cancer
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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).
49 Years
69 Years
ALL
No
Sponsors
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Parc de Salut Mar
OTHER
Corporacion Parc Tauli
OTHER
Responsible Party
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Anna Selva
Medical Doctor
Locations
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Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Selva A, Lopez P, Puig T, Macia F, Selva C, Alvarez-Perez Y, Terraza R, Buron A, Machlab ST, Pericay C, Sola I, Tora N, Rodriguez V, Barrufet C, Aymar A, Bare M. Patient experience, satisfaction and shared decision-making in colorectal cancer screening: protocol of the mixed-methods study CyDESA. BMJ Open. 2022 May 30;12(5):e057687. doi: 10.1136/bmjopen-2021-057687.
Other Identifiers
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PI18/00460
Identifier Type: -
Identifier Source: org_study_id
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