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

NCT03884868 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2021-08-04

No results posted yet for this study

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.

Conditions

  • Colo-rectal Cancer

Interventions

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.

Sponsors & Collaborators

  • Corporacion Parc Tauli

    lead OTHER

Principal Investigators

  • Pilar López-López, DUI · Corporació Sanitaria Parc Taulí

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2019-08-31
Completion
2019-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03884868 on ClinicalTrials.gov