Colonoscopy Motivation for Patients With Positive Immunochemical Fecal Test

Colon Cancer Clinical Trial

— Colofit+  

Official title:

Evaluation of a Motivational Phone Call Strategy to Improve Colonoscopy Participation, for Patients With a Positive Immunochemical Fecal Test : Colofit + Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03276091
• Other study ID #: IDRCB 2017-A00635-48
• Status: Completed
• Phase: N/A
• Start date: May 23, 2017
• Est. completion date: March 16, 2018

Study information

• Verified date: July 2018
• Source: Association pour le Dépistage Organisé des Cancers dans le Rhône
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with an immunochemical fecal test positive, have to undergo a colonoscopy. Around 10% doesn't realize the colonoscopy. This study evaluate the impact of a motivational phone call (given by a doctor) to improve colonoscopy participation. And try to understand why this patients don't want to make this examination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: March 16, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 51 Years to 77 Years

Eligibility

Inclusion Criteria:

• immunochemical fecal test positive but no colonoscopy performed despite a full sequence of reminder (3 letters)

Exclusion Criteria:

• colonoscopy done

Related Conditions & MeSH terms

• Colon Cancer

Intervention

Behavioral:
• Colofit+ intervention
Personnalized phone call, done by the medical student in the name of Adémas-69, organized cancers screening in the Rhône area association. This is a motivational call to encourage patients with an immunochemical fecal test positive, to realized their colonoscopy.

Locations

Country	Name	City	State
France	Ademas-69	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Patricia Soler-Michel

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participation to the colonoscopy	Colonoscopy done six months after our phone call	From date of phone call until the date of first documented colonoscopy assessed up to 6 months
Secondary	reasons for rejecting colonoscopy	we will ask to patients why they don't realized their colonoscopy	Reasons for rejecting colonoscopy will be assessed during the phone call only, and assessed until the end of this phone call
Secondary	cancer and adenoma detected	number of cancer and adenoma detected during colonoscopy	From date of phone call until the date of first documented colonoscopy result assessed up to 6 months after phone call