Colonoscopy Motivation for Patients With Positive Immunochemical Fecal Test (Colofit+)

July 2, 2018 updated by: Patricia Soler-Michel

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69005
        • Adémas-69

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • colonoscopy done

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: COLOFIT+ Study
Personnalized motivational phone call, done by a medical physician
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participation to the colonoscopy
Time Frame: From date of phone call until the date of first documented colonoscopy assessed up to 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
reasons for rejecting colonoscopy
Time Frame: Reasons for rejecting colonoscopy will be assessed during the phone call only, and assessed until the end of this phone call
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
cancer and adenoma detected
Time Frame: From date of phone call until the date of first documented colonoscopy result assessed up to 6 months after phone call
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Patricia Soler-Michel

Investigators

  • Study Director: Thierry Ponchon, PHD, Hôpital Edouard Herriot

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2017

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

March 16, 2018

Study Registration Dates

First Submitted

September 6, 2017

First Submitted That Met QC Criteria

September 6, 2017

First Posted (Actual)

September 8, 2017

Study Record Updates

Last Update Posted (Actual)

July 3, 2018

Last Update Submitted That Met QC Criteria

July 2, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDRCB 2017-A00635-48

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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