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

Primary Purpose

Colo-rectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Iconographies to communicate risks
Sponsored by
Corporacion Parc Tauli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Colo-rectal Cancer focused on measuring Colorectal cancer screening, Iconographies, Risk communication, Patient medical knowledge

Eligibility Criteria

50 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Parc Taulí Hospital Universitari

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Intervention group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

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

Full Information

First Posted
March 18, 2019
Last Updated
August 3, 2021
Sponsor
Corporacion Parc Tauli
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1. Study Identification

Unique Protocol Identification Number
NCT03884868
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporacion Parc Tauli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colo-rectal Cancer
Keywords
Colorectal cancer screening, Iconographies, Risk communication, Patient medical knowledge

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two consecutive study groups (no-concurrent).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Iconographies to communicate risks
Intervention Description
Use of iconographies to communicate the risks of the different possible diagnosis after a positive FIT during the screening program nurse visit.
Primary Outcome Measure Information:
Title
Grade of distress experienced by patients
Description
Grade of distress experienced by the patients measured with the Distress Thermometer (0-no distress to 10-high distress)
Time Frame
Minute 0 (before the nurse visit)
Title
Grade of distress experienced by patients
Description
Grade of distress experienced by the patients measured with the Distress Thermometer (0-no distress to 10-high distress)
Time Frame
at 30 minutes (after the nurse visit)
Secondary Outcome Measure Information:
Title
Grade of understanding of the information reported by patients
Description
Grade of understanding of the information measured with a visual analogical scale (0-no understanding, 10- high understanding)
Time Frame
at 30 minutes (after the nurse visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pilar López-López, DUI
Organizational Affiliation
Corporació Sanitaria Parc Taulí
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parc Taulí Hospital Universitari
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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