Colorectal Cancer ScreeningPRADONCT01555450
Study of Patient Navigation to Reduce Social Inequalities
A study testing Patient Navigation in people with Colorectal Cancer Screening, run by Institut National de la Santé Et de la Recherche Médicale, France at 3 sites in France.
Trial summary
Variations in participation to the colorectal cancer screening seems to reveal social and geographical inequalities. Our study will investigate whether patient navigation could increase the participation to the colorectal cancer screening and in the same time, reduce the social inequalities. Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Colorectal Cancer Screening
- What is being tested?
- Patient Navigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28,929 participants
- Where
- 3 sitesFrance
- Study dates
- Mar 2011to Nov 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Insured people invited to the national french colorectal screening program are from 50 to 74 years old.
- We select people who never do the screening test or are not compliant with it
- Among these people we select those living in the randomized geographical areas.
Who cannot join
- people who have already done the screening test at the two previous campaigns.
- people who have done a colonoscopy in the previous five years or people with a family history with colorectal cancer and people who are following outside of the screening program.
- people with other severe disease or in incapacity to realize the screening test
- people who have another exclusion criteria to realize the screening test.
Trial locations and contacts
3 sites in 1 country.
France3 sites
The french screening organization
Amiens, Region of Picardie, 80048
The french screening organization
Compiègne, Region of Picardie, 60312
The french screening organization
Laon, Region of Picardie, 02000
About this study
Official title: The Patient Navigator to Reduce Social Inequalities. A French Interventional Trial in Public Health
Variations in participation to the colorectal cancer screening seems to reveal social and geographical inequalities. Our study will investigate whether patient navigation could increase the participation to the colorectal cancer screening and in the same time, reduce the social inequalities.
- Conditions
- Colorectal Cancer Screening
- Being tested
- Patient Navigation
- Keywords
- Colorectal cancer screening, Social inequalities, Patient Navigator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient NavigationOther
Insured people receive firstly a letter to inform them that a patient navigator is available to navigate them during the colorectal screening steps. A free telephone number and the navigator schedule is given. After a minimum of one week the patient navigator begins the telephone outreach.
| Study group | Role | What they receive |
|---|---|---|
| With Patient Navigator | Experimental | People in this arm receive the Intervention of a Patient Navigator Receives: Other: Patient Navigation |
| Control - Without Patient Navigator | No intervention | People in this arm receive just the usual care of colorectal cancer screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of colorectal cancer screening
Measured: 2 years
Reduction of social inequalities
The participation rate to the colorectal cancer screening will be compared between privileged and deprived geographical areas for which the socio-economic status is measured with the Townsend index.
Measured: 2 years
Secondary outcomes (2)
Estimation of Cost effectiveness
We will assess the mean cost to navigate one person and compared it to a non navigate person. We will measure the cost effectiveness of the intervention in order to have the cost of the arising of 1% of the participation rate.
Measured: 2 years
Evaluation of psychological mechanisms
Evaluation of cognitive, behavioural, emotional mechanisms influencing the colorectal screening participation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startMar 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 28,929 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- Guy Launoy, Pr, Study director, CHU CAEN / INSERM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555450
- Sponsor's protocol ID
- R10051EE
- Acronym
- PRADO
- Status last verified
- Mar 2012
- First submitted
- 13 Mar 2012
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Dejardin O, Berchi C, Mignon A, Pornet C, Guillaume E, Guittet L, Bouvier V, Sailly M, Salinas A, Christophe V, Launoy G. [Social inequalities in health from observational studies to intervention: can the patient navigator reduce social inequalities in cancer patients?]. Rev Epidemiol Sante Publique. 2011 Feb;59(1):45-51. doi: 10.1016/j.respe.2010.10.008. Epub 2011 Jan 21. French.
PubMed 21256688De Mil R, Guillaume E, Guittet L, Dejardin O, Bouvier V, Pornet C, Christophe V, Notari A, Delattre-Massy H, De Seze C, Peng J, Launoy G, Berchi C. Cost-Effectiveness Analysis of a Navigation Program for Colorectal Cancer Screening to Reduce Social Health Inequalities: A French Cluster Randomized Controlled Trial. Value Health. 2018 Jun;21(6):685-691. doi: 10.1016/j.jval.2017.09.020. Epub 2017 Nov 10.
PubMed 29909873Guillaume E, Dejardin O, Bouvier V, De Mil R, Berchi C, Pornet C, Christophe V, Notari A, Delattre Massy H, De Seze C, Peng J, Guittet L, Launoy G. Patient navigation to reduce social inequalities in colorectal cancer screening participation: A cluster randomized controlled trial. Prev Med. 2017 Oct;103:76-83. doi: 10.1016/j.ypmed.2017.08.012. Epub 2017 Aug 16.
PubMed 28823681
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Patient Navigator to Reduce Social Inequalities. A French Interventional Trial in Public Health
- ClinicalTrials.gov ID
- NCT01555450
- Acronym / sponsor ID
- PRADO / R10051EE
- Conditions
- Colorectal Cancer Screening
- Keywords
- Colorectal cancer screening, Social inequalities, Patient Navigator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28,929 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- National Cancer Institute, France
- Study start
- Mar 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 15 Mar 2012 (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.
Variations in participation to the colorectal cancer screening seems to reveal social and geographical inequalities. Our study will investigate whether patient navigation could increase the participation to the colorectal cancer screening and in the same time, reduce the social inequalities.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Patient Navigator | Experimental | Other: Patient NavigationPeople in this arm receive the Intervention of a Patient Navigator |
| Control - Without Patient Navigator | No intervention | –People in this arm receive just the usual care of colorectal cancer screening |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Insured people invited to the national french colorectal screening program are from 50 to 74 years old.
- We select people who never do the screening test or are not compliant with it
- Among these people we select those living in the randomized geographical areas.
Key exclusion criteria (4 listed)
- people who have already done the screening test at the two previous campaigns.
- people who have done a colonoscopy in the previous five years or people with a family history with colorectal cancer and people who are following outside of the screening program.
- people with other severe disease or in incapacity to realize the screening test
- people who have another exclusion criteria to realize the screening test.
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 |
|---|---|---|
| Patient NavigationInsured people receive firstly a letter to inform them that a patient navigator is available to navigate them during the colorectal screening steps. A free telephone number and the navigator schedule is given. After a minimum of one week the patient navigator begins the telephone outreach. | Other | With Patient Navigator |
Primary outcome
Completion of colorectal cancer screening
Time frame: 2 years
Reduction of social inequalities
Time frame: 2 years
The participation rate to the colorectal cancer screening will be compared between privileged and deprived geographical areas for which the socio-economic status is measured with the Townsend index.
2 secondary outcomes
Estimation of Cost effectiveness
Time frame: 2 years
Evaluation of psychological mechanisms
Time frame: 2 years
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 4 Dec 2025.
- Background: PubMed 21256688Dejardin O, Berchi C, Mignon A, Pornet C, Guillaume E, Guittet L, Bouvier V, Sailly M, Salinas A, Christophe V, Launoy G. [Social inequalities in health from observational studies to intervention: can the patient navigator reduce social inequalities in cancer patients?]. Rev Epidemiol Sante Publique. 2011 Feb;59(1):45-51. doi: 10.1016/j.respe.2010.10.008. Epub 2011 Jan 21. French.
- Results publication: PubMed 29909873De Mil R, Guillaume E, Guittet L, Dejardin O, Bouvier V, Pornet C, Christophe V, Notari A, Delattre-Massy H, De Seze C, Peng J, Launoy G, Berchi C. Cost-Effectiveness Analysis of a Navigation Program for Colorectal Cancer Screening to Reduce Social Health Inequalities: A French Cluster Randomized Controlled Trial. Value Health. 2018 Jun;21(6):685-691. doi: 10.1016/j.jval.2017.09.020. Epub 2017 Nov 10.
- Results publication: PubMed 28823681Guillaume E, Dejardin O, Bouvier V, De Mil R, Berchi C, Pornet C, Christophe V, Notari A, Delattre Massy H, De Seze C, Peng J, Guittet L, Launoy G. Patient navigation to reduce social inequalities in colorectal cancer screening participation: A cluster randomized controlled trial. Prev Med. 2017 Oct;103:76-83. doi: 10.1016/j.ypmed.2017.08.012. Epub 2017 Aug 16.
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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.
Guy Launoy, Pr study director
CHU CAEN / INSERM
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigation in people with Colorectal Cancer Screening, run by Institut National de la Santé Et de la Recherche Médicale, France at 3 sites 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 3 inclusion and 4 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 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Completion of colorectal cancer screening (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT01555450, which also lists 3 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 4 Dec 2025.