Breast CancerGPsNCT02367001
Randomized Trial Evaluating the Effectiveness of the General Practitioner Involvement in Cancer Screening Invitations
A study testing Normal invitation, revised invitation signed by the coordinating doctor and Revised invitation signed by the attending physician in people with Breast Cancer and Colorectal Cancer, run by University Hospital, Tours at 1 site in France.
Trial summary
Our goal is to evaluate, in France, the effectiveness (in terms of participation) of the general practitioner involvement (signature) and a more personalized communication in invitation letters to organized screening of breast, colorectal and cervical cancers. Read more about this study
- Who is it for?
- Ages 25 to 74 years
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Cervical Cancer
- What is being tested?
- Normal invitation, revised invitation signed by the coordinating doctor and Revised invitation signed by the attending physician
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53,978 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Sep 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 25 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Living in Indre-et-Loire (french territorial division 37)
- Be affiliated to the following three health insurance companies: CPAM (Caisse Primaire d'Assurance Maladie), MSA (Mutualité Sociale Agricole), or RSI (Régime social des Indépendants)
- Having declared (to health insurance company) an attending physician who has given its written consent to participate in the study
- Present no exclusion criterion to cancer screening ( for each one)
- Be old from 50 to 74 years (breast and colorectal cancer) or from 25 to 65 years (cervical cancer)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Coordination des Dépistages des Cancers (CCDC)
Tours, 37044
About this study
Official title: Randomized Trial Evaluating the Effectiveness of a "Targeted Communication" With the General Practitioner Involvement in Cancer Screening Invitation Letters
Our goal is to evaluate, in France, the effectiveness (in terms of participation) of the general practitioner involvement (signature) and a more personalized communication in invitation letters to organized screening of breast, colorectal and cervical cancers.
The hypothesis on which this project is based is that communication is probably more effective if the "receiver" feels personally targeted by invitation letters (Dear Martin, I am writing ...) and if he knows "the issuer "(his general practitioner rather an unknown person).
- Conditions
- Breast Cancer, Colorectal Cancer, Cervical Cancer
- Being tested
- Normal invitation, revised invitation signed by the coordinating doctor, Revised invitation signed by the attending physician
- Keywords
- general practitioner, screening, participation, organized screening
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal invitationOther
No modification and signed by the coordinating doctor as usual
revised invitation signed by the coordinating doctorOther
Invitation with revised text and layout and signed by the coordinating doctor as usual
Revised invitation signed by the attending physicianOther
signature typed or typed + handwritten
| Study group | Role | What they receive |
|---|---|---|
| 1: standard invitation | Other | Group 1: sending a standard invitation signed by the coordinating doctor (send by the structure responsible for organized screenings)
Intervention : Normal invitation Receives: Other: Normal invitation |
| 2: Revised invitation | Experimental | Group 2: Sending a revised invitation ( text, layout) signed by the coordinating doctor (send by the structure responsible for organized screenings)
Intervention : revised invitation signed by the coordinating doctor Receives: Other: revised invitation signed by the coordinating doctor |
| 3 : revised invitation signed by the attending physician | Experimental | Group 3: Sending a revised invitation signed by the attending physician (send by the structure responsible for organized screenings)
Intervention : Revised invitation signed by the attending physician Receives: Other: Revised invitation signed by the attending physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect on the participation (of the population) in cancer screening of an intervention involving the general practitioner (integration of signature) in the invitation letters
The participation / non participation will be measured for each cancer screening (breast, colorectal and cervical) :
- 9 months after the invitation letters for breast and colorectal cancers
- 12 months after the invitation letters for cervical cancer
The participation rate is defined as the number of people having participated, divided by the total number of people in the group or subgroup considered.
Analysis by comparing the participation rates between groups (Group 1, Group 2 and Group 3) and sub-groups will be done.
Measured: 9 or 12 months after the invitation letters
Secondary outcomes (3)
Evaluate the effectiveness on the participation (of the population) of the use of a simplified and more focused communication in the invitation letters : comparison of the participation rates in arm 1 (normal invitation) and arm 2 (revised invitation)
Measured: 9 or 12 months after the invitation letters
Evaluate the effectiveness on the participation (of the population) of the two types of general practitioner signature (typed versus typed + handwritten) by comparing the participation rates between two sub-groups in the arm 3.
Measured: 9 or 12 months after the invitation letters
Cost-effectiveness of different strategies for each cancer screening (breast, colorectal and cervical) as measured by cost effectiveness ratio (total costs in Euros divided by total screened people)
Measured: 9 or 12 months after the invitation letters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startFeb 2014
- Primary completionJun 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Participant
- Enrolment
- 53,978 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ken HAGUENOER, Study director, University Hospital of TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367001
- Sponsor's protocol ID
- INCA-P3644-KH-GPs
- Acronym
- GPs
- Status last verified
- Feb 2015
- First submitted
- 28 Jan 2015
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Evaluating the Effectiveness of a "Targeted Communication" With the General Practitioner Involvement in Cancer Screening Invitation Letters
- ClinicalTrials.gov ID
- NCT02367001
- Acronym / sponsor ID
- GPs / INCA-P3644-KH-GPs
- Conditions
- Breast Cancer, Colorectal Cancer, Cervical Cancer
- Keywords
- general practitioner, screening, participation, organized screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53,978 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 20 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.
Our goal is to evaluate, in France, the effectiveness (in terms of participation) of the general practitioner involvement (signature) and a more personalized communication in invitation letters to organized screening of breast, colorectal and cervical cancers.
The hypothesis on which this project is based is that communication is probably more effective if the "receiver" feels personally targeted by invitation letters (Dear Martin, I am writing ...) and if he knows "the issuer "(his general practitioner rather an unknown person).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1: standard invitation | Other | Other: Normal invitationGroup 1: sending a standard invitation signed by the coordinating doctor (send by the structure responsible for organized screenings) Intervention : Normal invitation |
| 2: Revised invitation | Experimental | Other: revised invitation signed by the coordinating doctorGroup 2: Sending a revised invitation ( text, layout) signed by the coordinating doctor (send by the structure responsible for organized screenings) Intervention : revised invitation signed by the coordinating doctor |
| 3 : revised invitation signed by the attending physician | Experimental | Other: Revised invitation signed by the attending physicianGroup 3: Sending a revised invitation signed by the attending physician (send by the structure responsible for organized screenings) Intervention : Revised invitation signed by the attending physician |
Who may qualify
- Ages
- 25 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Living in Indre-et-Loire (french territorial division 37)
- Be affiliated to the following three health insurance companies: CPAM (Caisse Primaire d'Assurance Maladie), MSA (Mutualité Sociale Agricole), or RSI (Régime social des Indépendants)
- Having declared (to health insurance company) an attending physician who has given its written consent to participate in the study
- Present no exclusion criterion to cancer screening ( for each one)
- Be old from 50 to 74 years (breast and colorectal cancer) or from 25 to 65 years (cervical cancer)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Normal invitationNo modification and signed by the coordinating doctor as usual | Other | 1: standard invitation |
| revised invitation signed by the coordinating doctorInvitation with revised text and layout and signed by the coordinating doctor as usual | Other | 2: Revised invitation |
| Revised invitation signed by the attending physiciansignature typed or typed + handwritten | Other | 3 : revised invitation signed by the attending physician |
Primary outcome
Evaluate the effect on the participation (of the population) in cancer screening of an intervention involving the general practitioner (integration of signature) in the invitation letters
Time frame: 9 or 12 months after the invitation letters
The participation / non participation will be measured for each cancer screening (breast, colorectal and cervical) : * 9 months after the invitation letters for breast and colorectal cancers * 12 months after the invitation letters for cervical cancer The participation rate is defined as the number of people having participated, divided by the total number of people in the group or subgroup considered. Analysis by comparing the participation rates between groups (Group 1, Group 2 and Group 3) and sub-groups will be done.
3 secondary outcomes
Evaluate the effectiveness on the participation (of the population) of the use of a simplified and more focused communication in the invitation letters : comparison of the participation rates in arm 1 (normal invitation) and arm 2 (revised invitation)
Time frame: 9 or 12 months after the invitation letters
Evaluate the effectiveness on the participation (of the population) of the two types of general practitioner signature (typed versus typed + handwritten) by comparing the participation rates between two sub-groups in the arm 3.
Time frame: 9 or 12 months after the invitation letters
Cost-effectiveness of different strategies for each cancer screening (breast, colorectal and cervical) as measured by cost effectiveness ratio (total costs in Euros divided by total screened people)
Time frame: 9 or 12 months after the invitation letters
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 1 Oct 2015.
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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.
Ken HAGUENOER study director
University Hospital of TOURS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal invitation, revised invitation signed by the coordinating doctor and Revised invitation signed by the attending physician in people with Breast Cancer and Colorectal Cancer, run by University Hospital, Tours 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 5 inclusion and 0 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 1 Oct 2015. 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?
Evaluate the effect on the participation (of the population) in cancer screening of an intervention involving the general practitioner (integration of signature) in the invitation letters (time frame: 9 or 12 months after the invitation letters). 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 1 Oct 2015.