Clinical trial NCT03884868: Iconographies for Risk Communication and Reduction of Patient's Anxiety in a Colorectal Cancer Screening Program
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colo-rectal Cancer
Keywords: Colorectal cancer screening
Iconographies
Risk communication
Patient medical knowledge
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 240
Sex: ALL
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two consecutive study groups (no-concurrent).
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Grade of distress experienced by patients
timeFrame: Minute 0 (before the nurse visit)
measure: Grade of distress experienced by patients
timeFrame: at 30 minutes (after the nurse visit)
Secondary outcomes:
measure: Grade of understanding of the information reported by patients
timeFrame: at 30 minutes (after the nurse visit)
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Parc Taulí Hospital Universitari
state: Barcelona
Study officials:
affiliation: Corporació Sanitaria Parc Taulí
name: Pilar López-López, DUI
role: PRINCIPAL_INVESTIGATOR
References: