Patients Navigator for Organized Colorectal Cancer Screening

Healthy Clinical Trial

— COLONAV  

Official title:

Patients Navigator for Organized Colorectal Cancer Screening in Underserved Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02369757
• Other study ID #: 2012-04
• Status: Completed
• Phase: N/A
• First received: December 5, 2014
• Last updated: February 26, 2016
• Start date: October 2012
• Est. completion date: May 2015

Study information

• Verified date: November 2014
• Source: Institut de Cancérologie de la Loire
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Commission nationale de l'informatique et des libertés
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40774
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 74 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Healthy

Intervention

Behavioral:
• Navigator intervention
peers sharing common characteristics with the target population whose mission is to accompany towards OCCS

Locations

Country	Name	City	State
France	Institut de cancérologie Lucien Neuwirth	Saint-Priest-en-Jarez

Sponsors (4)

Lead Sponsor	Collaborator
Institut de Cancérologie de la Loire	Centre Georges Francois Leclerc, Gustave Roussy, Cancer Campus, Grand Paris, University of Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participation rates	Participation rates between intervention areas and control areas before/after intervention	24 months	No
Secondary	Percentage of patients primary care peers take care of		24 months	No
Secondary	Qualitative analysis	A questionnaire will be given to those contacted and some people will be interviewed	1 hour	No