Colorectal CancerPagedocc1NCT01279278
Does the Invitation by the General Practitioner Improve Patients' Participation in Colorectal Cancer Screening?
A study testing Co-signed letter and Classical Letter in people with Colorectal Cancer, run by University of Paris 5 - Rene Descartes at 1 site in France.
Trial summary
The propose of this study is to assess the effect of general practitioner's involvement on first patients' solicitation in screening for colorectal cancer by testing for faecal occult blood (FOBT). Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Co-signed letter and Classical Letter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,700 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2010to Apr 2011
- 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
- Aged : 50 to 74 years.
- Not having ever been invited to participate in colorectal screening.
Who cannot join
- Patients who have a Fecal Occult Blood Test for less than 2 years or a colonoscopy within the past 5 years or excluded for medical reasons (according to information known from ADECA).
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Université Paris Descartes
Paris, Île-de-France Region, 75014
Barthe, 01 44 41 23 63, juliette.barthe@gmail.com
About this study
Official title: Does the Invitation by the General Practitioner Improve Patients' Participation in Colorectal Cancer Screening? A Cluster Randomised Controlled Study.
The propose of this study is to assess the effect of general practitioner's involvement on first patients' solicitation in screening for colorectal cancer by testing for faecal occult blood (FOBT).
- Conditions
- Colorectal Cancer
- Being tested
- Co-signed letter, Classical Letter
- Keywords
- Colorectal Cancer, Screening, General Practitioner, Fecal Occult Blood Tests
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-signed letterOther
Patients receive a personalized letter co-signed by their general practitioner and the medical coordinator of ADECA.
Classical LetterOther
Patients receive classical letter signed by the coordinator doctor of ADECA
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described Receives: Other: Classical Letter |
| Co-signed Letter | Experimental | Not described Receives: Other: Co-signed letter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of Fecal Occult Blod Test
Increased number of patients who completed the test for faecal occult blood following the first solicitation with the letter co-signed by general practitioner, compared with the conventional solicition(including replies exclusions).
Measured: 7 months
Secondary outcomes (3)
Measure the impact of co-signing on deadline for completion of the test after the mailing.
Measured: 7 months
Compare the proportion of uninterpretable tests.
Measured: 7 months
Compare the rate of completion of colonoscopy after a positive test (information received by ADECA in the follow-up), according to the specifications.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startSep 2010
- Primary completionApr 2011 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Paris 5 - Rene Descartes
- Sponsor type
- University, hospital or other
- Collaborators
- Adeca 75, Société de Formation Thérapeutique du Généraliste, Hotel Dieu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279278
- Sponsor's protocol ID
- PAGEDOCC1
- Acronym
- Pagedocc1
- Status last verified
- Sep 2010
- First submitted
- 18 Jan 2011
- Last updated
- 19 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Invitation by the General Practitioner Improve Patients' Participation in Colorectal Cancer Screening? A Cluster Randomised Controlled Study.
- ClinicalTrials.gov ID
- NCT01279278
- Acronym / sponsor ID
- Pagedocc1 / PAGEDOCC1
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, Screening, General Practitioner, Fecal Occult Blood Tests
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,700 participants (estimated)
- Lead sponsor
- University of Paris 5 - Rene DescartesUniversity, hospital or other
- Collaborators
- Adeca 75, Société de Formation Thérapeutique du Généraliste, Hotel Dieu Hospital
- Study start
- Sep 2010
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 19 Jan 2011 (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 propose of this study is to assess the effect of general practitioner's involvement on first patients' solicitation in screening for colorectal cancer by testing for faecal occult blood (FOBT).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | Other: Classical Letter |
| Co-signed Letter | Experimental | Other: Co-signed letter |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged : 50 to 74 years.
- Not having ever been invited to participate in colorectal screening.
Key exclusion criteria (1 listed)
- Patients who have a Fecal Occult Blood Test for less than 2 years or a colonoscopy within the past 5 years or excluded for medical reasons (according to information known from ADECA).
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 |
|---|---|---|
| Co-signed letterPatients receive a personalized letter co-signed by their general practitioner and the medical coordinator of ADECA. | Other | Co-signed Letter |
| Classical LetterPatients receive classical letter signed by the coordinator doctor of ADECA | Other | Control |
Primary outcome
Completion of Fecal Occult Blod Test
Time frame: 7 months
Increased number of patients who completed the test for faecal occult blood following the first solicitation with the letter co-signed by general practitioner, compared with the conventional solicition(including replies exclusions).
3 secondary outcomes
Measure the impact of co-signing on deadline for completion of the test after the mailing.
Time frame: 7 months
Compare the proportion of uninterpretable tests.
Time frame: 7 months
Compare the rate of completion of colonoscopy after a positive test (information received by ADECA in the follow-up), according to the specifications.
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Co-signed letter and Classical Letter in people with Colorectal Cancer, run by University of Paris 5 - Rene Descartes 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 1 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: status not confirmed, as of the sponsor's last update on 19 Jan 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serge Gilberg (01 44 41 23 63, gilberg@parisdescartes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of Fecal Occult Blod Test (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2011.