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

Sponsor
Corporacion Parc Tauli (Other)
Overall Status
Completed
CT.gov ID
NCT03884868
Collaborator
(none)
240
Enrollment
1
Location
2
Arms
9
Actual Duration (Months)
26.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Iconographies to communicate risks
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
240 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two consecutive study groups (no-concurrent).Two consecutive study groups (no-concurrent).
Masking:
None (Open Label)
Primary Purpose:
Other
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
Actual Study Start Date :
Apr 1, 2019
Actual Primary Completion Date :
Aug 31, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control group

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.
Experimental: Intervention group

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

Outcome Measures

Primary Outcome Measures

  1. Grade of distress experienced by patients [Minute 0 (before the nurse visit)]

    Grade of distress experienced by the patients measured with the Distress Thermometer (0-no distress to 10-high distress)

  2. Grade of distress experienced by patients [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 Outcome Measures

  1. Grade of understanding of the information reported by patients [at 30 minutes (after the nurse visit)]

    Grade of understanding of the information measured with a visual analogical scale (0-no understanding, 10- high understanding)

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 69 Years
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Parc Taulí Hospital Universitari Sabadell Barcelona Spain 08208

Sponsors and Collaborators

  • Corporacion Parc Tauli

Investigators

  • Principal Investigator: Pilar López-López, DUI, Corporació Sanitaria Parc Taulí

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pilar Lopez-Lopez, Principal Investigator, Corporacion Parc Tauli
ClinicalTrials.gov Identifier:
NCT03884868
Other Study ID Numbers:
  • 20198501
First Posted:
Mar 21, 2019
Last Update Posted:
Aug 4, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pilar Lopez-Lopez, Principal Investigator, Corporacion Parc Tauli
Colorectal cancer screening
Iconographies
Risk communication
Patient medical knowledge
Additional relevant MeSH terms:
Colorectal Neoplasms

Study Results

No Results Posted as of Aug 4, 2021