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

NCT04610086 | Completed

• 1 other identifier: PI18/00460
• Study Type: observational
• Target: 846
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Satisfaction, Patient

Outcome Measures

Primary Outcomes (1)

• Perception of Shared Decision Making

  Perception of participants of shared decision making

  2 months

Secondary Outcomes (3)

• Satisfaction with the screening process

  2 months

• Satisfaction with diagnosis and treatment of cancer

  at 6 months

• Participation in cancer decision making

  at 6 months

Study Arms (3)

False positive FIT

Participants in the colorectal cancer screening program, with a positive FIT and with a normal colonoscopy

Polyps

Participants in the colorectal cancer screening program, with a positive FIT and diagnosed of colorectal polyps in the colonoscopy

Colorectal cancer

Participants in the colorectal cancer screening program, with a positive FIT diagnosed by colorectal cancer

Eligibility Criteria

• Age: 49 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participans in the colorectal cancer screening program with a positive results in the immunological fecal test.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Corporacion Parc Tauli: lead
• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: collaborator
• Parc de Salut Mar: collaborator

Study Sites (1)

Corporació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Related Publications (1)

• 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.

  PMID: 35636783 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Patient Satisfaction

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: October 30, 2020
• Study Start: February 19, 2021
• Primary Completion: June 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)