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OpenTrials
Completed

NCT Number: NCT03884868

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

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.

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Key information

Age range

50 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Parc Taulí Hospital Universitari

Sabadell, Barcelona, 08208, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iconographies to communicate risks

Other

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Official study title

Use of Iconographies for Risk Communication and Reduction of Patient's Anxiety During the Nurse Information Visit in the Colorectal Cancer Screening Program

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 21, 2019
Registry last updated
Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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