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

C

Corporacion Parc Tauli

Status

Unknown

Conditions

Satisfaction, Patient
Colorectal Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT04610086
PI18/00460

Details and patient eligibility

About

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.

Enrollment

850 estimated patients

Sex

All

Ages

49 to 69 years old

Volunteers

No Healthy Volunteers

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).

Trial design

850 participants in 3 patient groups

False positive FIT
Description:
Participants in the colorectal cancer screening program, with a positive FIT and with a normal colonoscopy
Polyps
Description:
Participants in the colorectal cancer screening program, with a positive FIT and diagnosed of colorectal polyps in the colonoscopy
Colorectal cancer
Description:
Participants in the colorectal cancer screening program, with a positive FIT diagnosed by colorectal cancer

Trial contacts and locations

1

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Central trial contact

Anna Selva Olid, MD

Data sourced from clinicaltrials.gov

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