Clinical trial 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
Official title: Shared Decision Making and Satisfaction With the Diagnostic-therapeutic Process in the Context of the Colorectal Cancer Screening Program. The CyDESA Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Satisfaction, Patient
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Parc de Salut Mar
First posted: 2020-10-30
Enrollment: 850
Sex: ALL
Minimum age (years): 49
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participans in the colorectal cancer screening program with a positive results in the immunological fecal test.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Satisfaction
timeFrame: Once the screening process is finished
Secondary outcomes:
measure: Participation in decision making
timeFrame: Once the screening process is finished
measure: Satisfaction with diagnosis and treatment of cancer
timeFrame: at 6 months
measure: Participation in cancer decision making
timeFrame: at 6 months
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporació Sanitària Parc Taulí
state: Barcelona
Study officials:
References:
citation: 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.