HealthyCOLONAVNCT02369757
Patients Navigator for Organized Colorectal Cancer Screening
A study testing Navigator intervention in people with Healthy, run by Institut de Cancérologie de la Loire at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Navigator intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40,774 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- person living in the IRIS intervention zones
- person invited by the local management structure to participate in colorectal cancer screening
Who cannot join
- person not living in the IRIS intervention zone
- person not invited by the local management structure to participate to colorectal cancer screening
Trial locations and contacts
1 site in 1 country.
France1 site
Institut de cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42270
About this study
Official title: Patients Navigator for Organized Colorectal Cancer Screening in Underserved Population
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.
- Conditions
- Healthy
- Being tested
- Navigator intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigator interventionBehavioural
peers sharing common characteristics with the target population whose mission is to accompany towards OCCS
| Study group | Role | What they receive |
|---|---|---|
| Intervention of navigators | Experimental | Navigators accompany the target population towards OCCS. Receives: Behavioral: Navigator intervention |
| No Intervention | No intervention | Population is not accompanied by navigators |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation rates
Participation rates between intervention areas and control areas before/after intervention
Measured: 24 months
Secondary outcomes (2)
Percentage of patients primary care peers take care of
Measured: 24 months
Qualitative analysis
A questionnaire will be given to those contacted and some people will be interviewed
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startOct 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40,774 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de la Loire
- Sponsor type
- University, hospital or other
- Collaborators
- Gustave Roussy, Cancer Campus, Grand Paris, University of Lyon, Centre Georges Francois Leclerc
- Responsible party
- Sponsor
- Investigators
- Franck Chauvin, PhDMD, Study chair, Institut de Cancérologie Lucien Neuwirth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369757
- Sponsor's protocol ID
- 2012-04
- Acronym
- COLONAV
- Status last verified
- Nov 2014
- First submitted
- 5 Dec 2014
- Last updated
- 29 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36609248Allary 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.
PubMed 27388807
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients Navigator for Organized Colorectal Cancer Screening in Underserved Population
- ClinicalTrials.gov ID
- NCT02369757
- Acronym / sponsor ID
- COLONAV / 2012-04
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40,774 participants (actual)
- Lead sponsor
- Institut de Cancérologie de la LoireUniversity, hospital or other
- Collaborators
- Gustave Roussy, Cancer Campus, Grand Paris, University of Lyon, Centre Georges Francois Leclerc
- Study start
- Oct 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 24 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention of navigators | Experimental | Behavioral: Navigator interventionNavigators accompany the target population towards OCCS. |
| No Intervention | No intervention | –Population is not accompanied by navigators |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- person living in the IRIS intervention zones
- person invited by the local management structure to participate in colorectal cancer screening
Key exclusion criteria (2 listed)
- person not living in the IRIS intervention zone
- person not invited by the local management structure to participate to colorectal cancer screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navigator interventionpeers sharing common characteristics with the target population whose mission is to accompany towards OCCS | Behavioural | Intervention of navigators |
Primary outcome
Participation rates
Time frame: 24 months
Participation rates between intervention areas and control areas before/after intervention
2 secondary outcomes
Percentage of patients primary care peers take care of
Time frame: 24 months
Qualitative analysis
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
- Derived from this study: PubMed 36609248Bourmaud 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.
- Derived from this study: PubMed 27388807Allary 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franck Chauvin, PhDMD study chair
Institut de Cancérologie Lucien Neuwirth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigator intervention in people with Healthy, run by Institut de Cancérologie de la Loire at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation rates (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02369757, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2016.