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

Colo-rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03884868
• Other study ID #: 20198501
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2021
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colo-rectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Iconographies to communicate risks
Use of iconographies to communicate the risks of the different possible diagnosis after a positive FIT during the screening program nurse visit.

Locations

Country	Name	City	State
Spain	Parc Taulí Hospital Universitari	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Minute 0 (before the nurse visit)
Primary	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)	at 30 minutes (after the nurse visit)
Secondary	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)	at 30 minutes (after the nurse visit)