NCT03276091

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2018

Completed
Last Updated

July 3, 2018

Status Verified

July 1, 2018

Enrollment Period

7 months

First QC Date

September 6, 2017

Last Update Submit

July 2, 2018

Conditions

Keywords

colonoscopyimmunochemical fecal testscreening

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • reasons for rejecting 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

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

Study Arms (1)

COLOFIT+ Study

EXPERIMENTAL

Personnalized motivational phone call, done by a medical physician

Behavioral: Colofit+ intervention

Interventions

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.

COLOFIT+ Study

Eligibility Criteria

Age51 Years - 77 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • colonoscopy done

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ademas-69

Lyon, 69005, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Thierry Ponchon, PHD

    Hopital Edouard Herriot

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
ADEMAS69

Study Record Dates

First Submitted

September 6, 2017

First Posted

September 8, 2017

Study Start

May 23, 2017

Primary Completion

December 31, 2017

Study Completion

March 16, 2018

Last Updated

July 3, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations