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NCT03884868
Iconographies for Risk Communication and Reduction of Patient's Anxiety in a Colorectal Cancer Screening Program
NA trial testing Iconographies to communicate risks in Colo-rectal Cancer in 240 participants. Completed in 31 December 2019.
31 August 2019
Quick facts
| Lead sponsor | Corporacion Parc Tauli |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 240 |
| Start date | 1 April 2019 |
| Primary completion | 31 August 2019 |
| Estimated completion | 31 December 2019 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Iconographies to communicate risks
Conditions studied
- Colo-rectal Cancer — all drugs for Colo-rectal Cancer →
Sponsor
Corporacion Parc Tauli — full company profile →
Who can join
Adults 50 to 69, any sex, with Colo-rectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03884868
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Other Corporacion Parc Tauli trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03884868 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Corporacion Parc Tauli
- Last refreshed: 4 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03884868.
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