Iconographies for Risk Communication and Reduction of Patient's Anxiety in a Colorectal Cancer Screening Program

Not Applicable

Completed

• Conditions: Colo-rectal Cancer
• Interventions: Other: Iconographies to communicate risks

• Registration Number: NCT03884868
• Lead Sponsor: Corporacion Parc Tauli

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-03-20
• Study First Posted: 2019-03-21
• Study Start: 2019-04-01
• Primary Completion: 2019-08-31
• Study Completion: 2019-12-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-03
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Iconographies to communicate risks	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.

Primary Outcome Measures

Name	Time	Method
Grade of distress experienced by patients	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)

Secondary Outcome Measures

Name	Time	Method
Grade of understanding of the information reported by patients	at 30 minutes (after the nurse visit)	Grade of understanding of the information measured with a visual analogical scale (0-no understanding, 10- high understanding)

Trial Locations

Locations (1)

Parc Taulí Hospital Universitari; 🇪🇸 Sabadell, Barcelona, Spain