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

Primary Purpose

Colon Cancer

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Colofit+ intervention

About this trial

This is an interventional other trial for Colon Cancer focused on measuring colonoscopy, immunochemical fecal test, screening

Eligibility Criteria

51 Years - 77 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

colonoscopy done

Sites / Locations

Ademas-69

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

COLOFIT+ Study

Arm Description

Personnalized motivational phone call, done by a medical physician

Outcomes

Primary Outcome Measures

Participation to the colonoscopy

Colonoscopy done six months after our phone call

Secondary Outcome Measures

reasons for rejecting colonoscopy

we will ask to patients why they don't realized their colonoscopy

cancer and adenoma detected

number of cancer and adenoma detected during colonoscopy

Full Information

NCT ID

NCT03276091

First Posted

September 6, 2017

Last Updated

July 2, 2018

Sponsor

Patricia Soler-Michel

1. Study Identification

Unique Protocol Identification Number

NCT03276091

Brief Title

Colonoscopy Motivation for Patients With Positive Immunochemical Fecal Test

Acronym

Colofit+

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

May 23, 2017 (Actual)

Primary Completion Date

December 31, 2017 (Actual)

Study Completion Date

March 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Patricia Soler-Michel

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Cancer

Keywords

colonoscopy, immunochemical fecal test, screening

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

127 (Actual)

8. Arms, Groups, and Interventions

Arm Title

COLOFIT+ Study

Arm Type

Experimental

Arm Description

Personnalized motivational phone call, done by a medical physician

Intervention Type

Behavioral

Intervention Name(s)

Colofit+ intervention

Intervention Description

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.

Primary Outcome Measure Information:

Title

Participation to the colonoscopy

Description

Colonoscopy done six months after our phone call

Time Frame

From date of phone call until the date of first documented colonoscopy assessed up to 6 months

Secondary Outcome Measure Information:

Title

reasons for rejecting colonoscopy

Description

we will ask to patients why they don't realized their colonoscopy

Time Frame

Reasons for rejecting colonoscopy will be assessed during the phone call only, and assessed until the end of this phone call

Title

cancer and adenoma detected

Description

number of cancer and adenoma detected during colonoscopy

Time Frame

From date of phone call until the date of first documented colonoscopy result assessed up to 6 months after phone call

10. Eligibility

Sex

All

Minimum Age & Unit of Time

51 Years

Maximum Age & Unit of Time

77 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: immunochemical fecal test positive but no colonoscopy performed despite a full sequence of reminder (3 letters) Exclusion Criteria: colonoscopy done

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thierry Ponchon, PHD

Organizational Affiliation

Hopital Edouard Herriot

Official's Role

Study Director

Facility Information:

Facility Name

Ademas-69

City

Lyon

ZIP/Postal Code

69005

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30197186

Citation

Gandilhon C, Soler-Michel P, Vecchiato L, Chaunier C, Fay I, Walter T, Rivory J, Saurin JC, Ponchon T, Pioche M. A motivational phone call improves participation to screening colonoscopy for those with a positive FIT in a national screening programme (NCT 03276091). Dig Liver Dis. 2018 Dec;50(12):1309-1314. doi: 10.1016/j.dld.2018.08.007. Epub 2018 Aug 17.

Results Reference

derived

Learn more about this trial

Colonoscopy Motivation for Patients With Positive Immunochemical Fecal Test

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