Use of Iconographies for Risk Communication and Reduction of Patient's Anxiety During the Nurse Information Visit in the Colorectal Cancer Screening Program
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 240
- Locations
- 2
- Primary Endpoint
- Grade of distress experienced by patients
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 69 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Grade of distress experienced by patients
Time Frame: 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 Outcomes
- Grade of understanding of the information reported by patients(at 30 minutes (after the nurse visit))
Investigators
Pilar Lopez-Lopez
Principal Investigator
Corporacion Parc Tauli