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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Satisfaction, Patient

• Study Type: Observational
• Enrollment (Anticipated): 850

Contacts and Locations

• Study Contact: Name: Anna Selva Olid, MD; Phone Number: 22313 937231010; Email: aselva@tauli.cat

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Recruiting
      • Corporacio Sanitaria Parc Tauli
      • Contact: Anna Selva Olid, MD; Phone Number: 22313 +34937231010; Email: aselva@tauli.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 49 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction	Satisfaction with the colorectal cancer screening programm	Once the screening process is finished

Secondary Outcome Measures

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2020
• Primary Completion (Anticipated): February 19, 2022
• Study Completion (Anticipated): December 19, 2023

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): October 30, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 22, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: PI18/00460

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No