NCT02369757

Brief Summary

The main objective is to evaluate the impact of the recruitment and training of a peer-navigator on the participation rate of colorectal cancer screening among underserved area. The role of the navigator is to establish an intervention culturally-tailored to the inhabitants in order to promote the Fecal Occult Blood test (FOBT) and accompany the inhabitants to complementary exams, if needed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40,774

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable healthy

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

October 1, 2012

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 24, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

February 29, 2016

Status Verified

November 1, 2014

Enrollment Period

2.6 years

First QC Date

December 5, 2014

Last Update Submit

February 26, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Participation rates

    Participation rates between intervention areas and control areas before/after intervention

    24 months

Secondary Outcomes (2)

  • Percentage of patients primary care peers take care of

    24 months

  • Qualitative analysis

    1 hour

Study Arms (2)

Intervention of navigators

EXPERIMENTAL

Navigators accompany the target population towards OCCS.

Behavioral: Navigator intervention

No Intervention

NO INTERVENTION

Population is not accompanied by navigators

Interventions

peers sharing common characteristics with the target population whose mission is to accompany towards OCCS

Intervention of navigators

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • person living in the IRIS intervention zones
  • person invited by the local management structure to participate in colorectal cancer screening

You may not qualify if:

  • person not living in the IRIS intervention zone
  • person not invited by the local management structure to participate to colorectal cancer screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, 42270, France

Location

Related Publications (2)

  • Bourmaud A, Benoist Y, Tinquaut F, Allary C, Ramone-Louis J, Oriol M, Kalecinski J, Dutertre V, Lechopier N, Pommier M, Rousseau S, Dumas A, Amiel P, Regnier V, Buthion V, Chauvin F. Patient navigation for colorectal cancer screening in deprived areas: the COLONAV cluster randomized controlled trial. BMC Cancer. 2023 Jan 6;23(1):21. doi: 10.1186/s12885-022-10169-3.

  • Allary C, Bourmaud A, Tinquaut F, Oriol M, Kalecinski J, Dutertre V, Lechopier N, Pommier M, Benoist Y, Rousseau S, Regnier V, Buthion V, Chauvin F. ColoNav: patient navigation for colorectal cancer screening in deprived areas - Study protocol. BMC Cancer. 2016 Jul 7;16:416. doi: 10.1186/s12885-016-2469-9.

Study Officials

  • Franck Chauvin, PhDMD

    Institut de Cancérologie Lucien Neuwirth

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2014

First Posted

February 24, 2015

Study Start

October 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

February 29, 2016

Record last verified: 2014-11

Locations