Clincosm LogoSign in Get a demo

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

Sponsor
Corporacion Parc Tauli (Other)
Overall Status
Recruiting
CT.gov ID
NCT04610086
Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other), Parc de Salut Mar (Other)
850
Enrollment
1
Location
37
Anticipated Duration (Months)
23
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    850 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Shared Decision Making and Satisfaction With the Diagnostic-therapeutic Process in the Context of the Colorectal Cancer Screening Program. The CyDESA Study.
    Actual Study Start Date :
    Nov 19, 2020
    Anticipated Primary Completion Date :
    Feb 19, 2022
    Anticipated Study Completion Date :
    Dec 19, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Satisfaction [Once the screening process is finished]

      Satisfaction with the colorectal cancer screening programm

    Secondary Outcome Measures

    1. Participation in decision making [Once the screening process is finished]

      Patient perception of participation in decision making during the screening process

    2. Satisfaction with diagnosis and treatment of cancer [at 6 months]

      Satisfaction with the diagnostic and treatment processess of cancer

    3. Participation in cancer decision making [at 6 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    49 Years to 69 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Corporació Sanitària Parc Taulí Sabadell Barcelona Spain 08208

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anna Selva, Medical Doctor, Corporacion Parc Tauli
    ClinicalTrials.gov Identifier:
    NCT04610086
    Other Study ID Numbers:
    • PI18/00460
    First Posted:
    Oct 30, 2020
    Last Update Posted:
    Jul 28, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Colorectal Neoplasms

    Study Results

    No Results Posted as of Jul 28, 2021