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

NCT ID: NCT04610086

Last Updated: 2021-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

850 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-19

Study Completion Date

2023-12-19

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer Satisfaction, Patient

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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False positive FIT

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

No interventions assigned to this group

Polyps

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

No interventions assigned to this group

Colorectal cancer

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

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

49 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role collaborator

Parc de Salut Mar

OTHER

Sponsor Role collaborator

Corporacion Parc Tauli

OTHER

Sponsor Role lead

Responsible Party

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Anna Selva

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Corporació Sanitària Parc Taulí

Sabadell, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Anna Selva Olid, MD

Role: CONTACT

937231010 ext. 22313

Facility Contacts

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Anna Selva Olid, MD

Role: primary

+34937231010 ext. 22313

References

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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.

Reference Type DERIVED
PMID: 35636783 (View on PubMed)

Other Identifiers

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PI18/00460

Identifier Type: -

Identifier Source: org_study_id

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