Patients Navigator for Organized Colorectal Cancer Screening

NCT ID: NCT02369757

Last Updated: 2016-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40774 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention of navigators

Navigators accompany the target population towards OCCS.

Group Type EXPERIMENTAL

Navigator intervention

Intervention Type BEHAVIORAL

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

No Intervention

Population is not accompanied by navigators

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Navigator intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* person not living in the IRIS intervention zone
* person not invited by the local management structure to participate to colorectal cancer screening
Minimum Eligible Age

50 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role collaborator

University of Lyon

OTHER

Sponsor Role collaborator

Centre Georges Francois Leclerc

OTHER

Sponsor Role collaborator

Institut de Cancérologie de la Loire

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Franck Chauvin, PhDMD

Role: STUDY_CHAIR

Institut de Cancérologie Lucien Neuwirth

Locations

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Institut de cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 36609248 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27388807 (View on PubMed)

Other Identifiers

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2012-04

Identifier Type: -

Identifier Source: org_study_id