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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884868
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Pilar Lopez-Lopez, Corporacion Parc Tauli

Study Description
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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
Colo-rectal Cancer Other: Iconographies to communicate risks Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 : April 1, 2019
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Grade of distress experienced by patients [ Time Frame: 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 [ 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 Outcome Measures :
  1. Grade of understanding of the information reported by patients [ Time Frame: 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
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Ages Eligible for Study:   50 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884868


Contacts
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Contact: Anna Selva Olid, MD, MPH 937231010 ext 22313 aselva@tauli.cat

Locations
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Spain
Parc Taulí Hospital Universitari Recruiting
Sabadell, Barcelona, Spain, 08208
Contact: Anna Selva         
Sponsors and Collaborators
Corporacion Parc Tauli
Investigators
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Principal Investigator: Pilar López-López, DUI Corporació Sanitaria Parc Taulí
More Information
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Responsible Party: Pilar Lopez-Lopez, Principal Investigator, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT03884868    
Other Study ID Numbers: 20198501
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pilar Lopez-Lopez, Corporacion Parc Tauli:
Colorectal cancer screening
Iconographies
Risk communication
Patient medical knowledge
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases