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

• Conditions: Colorectal Cancer; Satisfaction, Patient

• Registration Number: NCT04610086
• Lead Sponsor: Corporacion Parc Tauli

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-10-26
• Study First Posted: 2020-10-30
• Study Start: 2020-11-19
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-22
• Last Update Posted: 2021-07-28
• Primary Completion: 2022-02-19
• Study Completion: 2023-12-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 850

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Satisfaction	Once the screening process is finished	Satisfaction with the colorectal cancer screening programm

Secondary Outcome Measures

Name	Time	Method
Participation in cancer decision making	at 6 months	Patient perception about participation in decision making during the diagnostic and treatment processess of cancer
Participation in decision making	Once the screening process is finished	Patient perception of participation in decision making during the screening process
Satisfaction with diagnosis and treatment of cancer	at 6 months	Satisfaction with the diagnostic and treatment processess of cancer

Trial Locations

Locations (1)

Corporació Sanitària Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain