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
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Two consecutive study groups (no-concurrent).|
|Masking:||None (Open Label)|
|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|
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.
- 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)
- 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)
- 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)
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
|Contact: Anna Selva Olid, MD, MPH||937231010 ext firstname.lastname@example.org|
|Parc Taulí Hospital Universitari||Recruiting|
|Sabadell, Barcelona, Spain, 08208|
|Contact: Anna Selva|
|Principal Investigator:||Pilar López-López, DUI||Corporació Sanitaria Parc Taulí|