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

NCT03884868 | Completed

• 1 other identifier: 20198501
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Colo-rectal Cancer

Keywords

Colorectal cancer screening; Iconographies; Risk communication; Patient medical knowledge

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (1)

• Grade of understanding of the information reported by patients

  at 30 minutes (after the nurse visit)

Study Arms (2)

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.

Other: Iconographies to communicate risks

Interventions

Iconographies to communicate risks OTHER

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

Intervention group

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Parc Taulí Hospital Universitari

Sabadell, Barcelona, 08208, Spain

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Pilar López-López, DUI

  Corporació Sanitaria Parc Taulí

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two consecutive study groups (no-concurrent).

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 21, 2019
• Study Start: April 1, 2019
• Primary Completion: August 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 4, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)