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Completed

NCT Number: NCT04610086

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

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Key information

Conditions

Colorectal Cancer Behavior Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Health Behavior Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Patient Satisfaction Rectal Diseases Satisfaction, Patient Treatment Adherence and Compliance

Age range

49 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Corporació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Perception of Shared Decision Making

    Time frame: 2 months

    Perception of participants of shared decision making

Secondary outcomes

  1. Satisfaction with the screening process

    Time frame: 2 months

    Satisfacion with the screening process

  2. Satisfaction with diagnosis and treatment of cancer

    Time frame: at 6 months

    Satisfaction with the diagnostic and treatment processess of cancer

  3. Participation in cancer decision making

    Time frame: at 6 months

    Patient perception about participation in decision making during the diagnostic and treatment processess of cancer

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Collaborators

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  • Parc de Salut Mar

Registry information

Official study title

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

Acronym: CyDESA

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 30, 2020
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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