Colorectal CancerCyDESANCT04610086
Shared Decision Making and Satisfaction With the Diagnostic-therapeutic Process in the Shared Decision Making and Satisfaction With Colorectal Cancer Screening. The CyDESA Study
An observational study of Colorectal Cancer and Satisfaction, Patient, run by Corporacion Parc Tauli at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 49 to 69 years
- Conditions the study is for
- Colorectal Cancer, Satisfaction, Patient
- How many people
- 846 participants
- Where
- 1 siteSpain
- Study dates
- 19 Feb 2021to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 49 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participans in the colorectal cancer screening program with a positive results in the immunological fecal test.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this 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.
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.
- Conditions
- Colorectal Cancer, Satisfaction, Patient
- Medical subject headings
- Colorectal Neoplasms, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of Shared Decision Making
Perception of participants of shared decision making
Measured: 2 months
Secondary outcomes (3)
Satisfaction with the screening process
Satisfacion with the screening process
Measured: 2 months
Satisfaction with diagnosis and treatment of cancer
Satisfaction with the diagnostic and treatment processess of cancer
Measured: at 6 months
Participation in cancer decision making
Patient perception about participation in decision making during the diagnostic and treatment processess of cancer
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start19 Feb 2021
- Primary completion30 Jun 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 846 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Parc de Salut Mar
- Responsible party
- Principal investigator, Anna Selva, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610086
- Sponsor's protocol ID
- PI18/00460
- Acronym
- CyDESA
- Status last verified
- Apr 2026
- First submitted
- 26 Oct 2020
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35636783
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making and Satisfaction With the Diagnostic-therapeutic Process in the Context of the Colorectal Cancer Screening Program. The CyDESA Study.
- ClinicalTrials.gov ID
- NCT04610086
- Acronym / sponsor ID
- CyDESA / PI18/00460
- Conditions
- Colorectal Cancer, Satisfaction, Patient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 846 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Parc de Salut Mar
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 49 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participans in the colorectal cancer screening program with a positive results in the immunological fecal test.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perception of Shared Decision Making
Time frame: 2 months
Perception of participants of shared decision making
3 secondary outcomes
Satisfaction with the screening process
Time frame: 2 months
Satisfaction with diagnosis and treatment of cancer
Time frame: at 6 months
Participation in cancer decision making
Time frame: at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Derived from this study: PubMed 35636783Selva 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Satisfaction, Patient, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception of Shared Decision Making (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04610086, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.