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

Colorectal Cancer Clinical Trial

— CyDESA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04610086
• Other study ID #: PI18/00460
• Status: Recruiting
• Start date: November 19, 2020
• Est. completion date: December 19, 2023

Study information

• Verified date: July 2021
• Source: Corporacion Parc Tauli
• Contact: Anna Selva Olid, MD
• Phone: 937231010
• Email: aselva[@]tauli.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 850
• Est. completion date: December 19, 2023
• Est. primary completion date: February 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 49 Years to 69 Years

Eligibility

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).

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Satisfaction, Patient

Locations

Country	Name	City	State
Spain	Corporació Sanitària Parc Taulí	Sabadell	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Corporacion Parc Tauli	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction	Satisfaction with the colorectal cancer screening programm	Once the screening process is finished
Secondary	Participation in decision making	Patient perception of participation in decision making during the screening process	Once the screening process is finished
Secondary	Satisfaction with diagnosis and treatment of cancer	Satisfaction with the diagnostic and treatment processess of cancer	at 6 months
Secondary	Participation in cancer decision making	Patient perception about participation in decision making during the diagnostic and treatment processess of cancer	at 6 months