Colo-rectal CancerNCT03884868
Iconographies for Risk Communication and Reduction of Patient's Anxiety in a Colorectal Cancer Screening Program
A study testing Iconographies to communicate risks in people with Colo-rectal Cancer, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
Background: Participants in the colon and rectal cancer (CRC) screening program that have a positive result in the Fecal Immunological Test (FIT) are visited by the screening nurse who explains the meaning of the positive test and the need to perform a colonoscopy. Read more about this study
- Who is it for?
- Ages 50 to 69 years
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- Iconographies to communicate risks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2019to 31 Dec 2019
- Phase
- Interventional
- 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 50 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women and men AND
- between 50 and 69 years of age AND
- who participate in the colorectal cancer screening program and have a positive result in the FIT AND
- who attend the nursing visit.
Who cannot join
- People who do not understand Catalan or Spanish OR
- with cognitive deterioration that prevents them from answering a questionnaire OR
- who do not know how to read or write.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Iconographies for Risk Communication and Reduction of Patient's Anxiety During the Nurse Information Visit in the Colorectal Cancer Screening Program
Background: Participants in the colon and rectal cancer (CRC) screening program that have a positive result in the Fecal Immunological Test (FIT) are visited by the screening nurse who explains the meaning of the positive test and the need to perform a colonoscopy. Having a positive result in the screening test can have a negative psychological impact on patients causing anguish.
Objective: To evaluate whether the use of iconographies to communicate the risks of possible diagnoses to patients with positive FIT improves the understanding of the information and reduces the degree of anguish.
Read more
Methods: Quasi-experimental pre-post intervention study with a control group. 240 individuals (men and women between 50-69 years of age, with a positive FIT result attending the nursing visit) will be included in two non-concurrent study groups (120 individuals per group). The control group will receive the nurse visit as usual. For the intervention group, the nurse will use iconographies to communicate the risk of the different possible diagnoses and the risk of complications of the colonoscopy. The degree of distress (Distress Thermometer and a scale of emotion-faces) will be measured before and after the visit and the understanding of the information (visual analog scale) after the visit. The degree of distress between the control group and intervention group will be compared.
If the results are favorable, the systematic use of iconographies can be implemented in the nursing screening visit and be extended to other Screening Units.
- Conditions
- Colo-rectal Cancer
- Being tested
- Iconographies to communicate risks
- Keywords
- Colorectal cancer screening, Iconographies, Risk communication, Patient medical knowledge
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iconographies to communicate risksOther
Use of iconographies to communicate the risks of the different possible diagnosis after a positive FIT during the screening program nurse visit.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Regular nursing visit: 1. Explanation of the meaning of a positive result in the FIT. 2. Explanation of the need to perform a colonoscopy with sedation. 3. Anamnesis. 4. Agreement of the day and hour to perform the colonoscopy. 5. Explanation of the diet and delivery of preparation for the preparation of the colon. |
| Intervention group | Experimental | In addition of the regular nursing visit: the nurse will use iconographies specially designed to communicate the risk of the different possible diagnoses and the complications of the colonoscopy. Because the risks are different according to sex and age, specific iconographies will be developed from the data available in the first screening round. Receives: Other: Iconographies to communicate risks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade of distress experienced by patients
Grade of distress experienced by the patients measured with the Distress Thermometer (0-no distress to 10-high distress)
Measured: Minute 0 (before the nurse visit)
Grade of distress experienced by patients
Grade of distress experienced by the patients measured with the Distress Thermometer (0-no distress to 10-high distress)
Measured: at 30 minutes (after the nurse visit)
Secondary outcomes (1)
Grade of understanding of the information reported by patients
Grade of understanding of the information measured with a visual analogical scale (0-no understanding, 10- high understanding)
Measured: at 30 minutes (after the nurse visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Apr 2019
- Primary completion31 Aug 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two consecutive study groups (no-concurrent).
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pilar Lopez-Lopez, Corporacion Parc Tauli
- Investigators
- Pilar López-López, DUI, Principal investigator, Corporació Sanitaria Parc Taulí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884868
- Sponsor's protocol ID
- 20198501
- Status last verified
- Aug 2021
- First submitted
- 18 Mar 2019
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Iconographies for Risk Communication and Reduction of Patient's Anxiety During the Nurse Information Visit in the Colorectal Cancer Screening Program
- ClinicalTrials.gov ID
- NCT03884868
- Acronym / sponsor ID
- 20198501
- Conditions
- Colo-rectal Cancer
- Keywords
- Colorectal cancer screening, Iconographies, Risk communication, Patient medical knowledge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 21 Mar 2019 (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.
Background: Participants in the colon and rectal cancer (CRC) screening program that have a positive result in the Fecal Immunological Test (FIT) are visited by the screening nurse who explains the meaning of the positive test and the need to perform a colonoscopy. Having a positive result in the screening test can have a negative psychological impact on patients causing anguish.
Objective: To evaluate whether the use of iconographies to communicate the risks of possible diagnoses to patients with positive FIT improves the understanding of the information and reduces the degree of anguish.
Methods: Quasi-experimental pre-post intervention study with a control group. 240 individuals (men and women between 50-69 years of age, with a positive FIT result attending the nursing visit) will be included in two non-concurrent study groups (120 individuals per group). The control group will receive the nurse visit as usual. For the intervention group, the nurse will use iconographies to communicate the risk of the different possible diagnoses and the risk of complications of the colonoscopy. The degree of distress (Distress Thermometer and a scale of emotion-faces) will be measured before and after the visit and the understanding of the information (visual analog scale) after the visit. The degree of distress between the control group and intervention group will be compared.
If the results are favorable, the systematic use of iconographies can be implemented in the nursing screening visit and be extended to other Screening Units.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two consecutive study groups (no-concurrent).
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Regular nursing visit: 1. Explanation of the meaning of a positive result in the FIT. 2. Explanation of the need to perform a colonoscopy with sedation. 3. Anamnesis. 4. Agreement of the day and hour to perform the colonoscopy. 5. Explanation of the diet and delivery of preparation for the preparation of the colon. |
| Intervention group | Experimental | Other: Iconographies to communicate risksIn addition of the regular nursing visit: the nurse will use iconographies specially designed to communicate the risk of the different possible diagnoses and the complications of the colonoscopy. Because the risks are different according to sex and age, specific iconographies will be developed from the data available in the first screening round. |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- women and men AND
- between 50 and 69 years of age AND
- who participate in the colorectal cancer screening program and have a positive result in the FIT AND
- who attend the nursing visit.
Key exclusion criteria (3 listed)
- People who do not understand Catalan or Spanish OR
- with cognitive deterioration that prevents them from answering a questionnaire OR
- who do not know how to read or write.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iconographies to communicate risksUse of iconographies to communicate the risks of the different possible diagnosis after a positive FIT during the screening program nurse visit. | Other | Intervention group |
Primary outcome
Grade of distress experienced by patients
Time frame: Minute 0 (before the nurse visit)
Grade of distress experienced by the patients measured with the Distress Thermometer (0-no distress to 10-high distress)
Grade of distress experienced by patients
Time frame: at 30 minutes (after the nurse visit)
Grade of distress experienced by the patients measured with the Distress Thermometer (0-no distress to 10-high distress)
1 secondary outcome
Grade of understanding of the information reported by patients
Time frame: at 30 minutes (after the nurse visit)
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 4 Aug 2021.
- 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.
Pilar López-López, DUI principal investigator
Corporació Sanitaria Parc Taulí
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iconographies to communicate risks in people with Colo-rectal Cancer, 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 4 inclusion and 3 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 4 Aug 2021. 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?
Grade of distress experienced by patients (time frame: Minute 0 (before the nurse visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2021.