Breast CancerDEDICACES2NCT05607849
Breast Cancer Screening Uptake: a Randomized Controlled Trial Assessing the Effect of a Decisional Aid
A study testing The decidons ensemble (let's decide together) leaflet and the https://lamammo-etvous.fr/ (let's talk about breast cancer screening) online tool. in people with Breast Cancer, run by Nantes University Hospital at 1 site in France.
Trial summary
Shared decision-making for organised breast cancer screening (OBCS) could be improved by fostering interaction and exchanges of information between women and General Practitioners (GPs), for instance by including an assistance tool in the dispatch of the invitation letter for Organised Screening for breast cancer. Read more about this study
- Who is it for?
- Ages 50 to 74 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- The decidons ensemble (let's decide together) leaflet and the https://lamammo-etvous.fr/ (let's talk about breast cancer screening) online tool.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 1 siteFrance
- Study dates
- 16 Apr 2025to 15 Sep 2025
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General practitioners (GPs):
- The following GPs will be included:
- 1) Practicing in one of the French départements (administrative area) covered by the study.
- Women:
- The following women will be included:
- Invited to participate in OBCS by the National Health Insurance Agency (Caisse Nationale d'Assurance Maladie; CNAM) during the studied month: eligible for OBCS, therefore aged between 50 and 74 at the time of inclusion;
- On the patient list of a GP who is covered by the study at the time of inclusion;
- Covered by one of the CPAM (Caisse Primaire d'Assurance Maladie) in the participating departments.
Who cannot join
- General practitioners (GPs) :
- The following GPs will be excluded:
- Those who do not have any patients invited for OBCS in the studied month;
- Those whose practice does not correspond to the usual activities of a GP (known as a Mode d'Exercice Particulier), or who have very few patients (who have seen fewer than 100 different patients in the year preceding the experiment);
- Those who practice within a health centre (as it is impossible to evaluate the activity of an individual practitioner in health insurance databases);
- Those who explicitly state that they do not want to take part in the study, in response to an initial letter of invitation. This letter will inform them that the study is being run, and will inform them of the option to refuse to participate if they so wish;
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- Those who are participating in the MyPEBS study (the only national study of OBCS at the time the present protocol was drawn up).
- Women:
- The following women will not be included:
- Participants in the MyPEBS study ( the only national study of OBCS at the time the present protocol was drawn up); or,
- If their GP refuses to participate in the study; or,
- women under guardianship.
- The following women will be excluded:
- Those who object to the study in accordance with regulatory procedures issued by the Data Protection Officer (DPO),
- Those who do not respond within 1 month after the questionnaire has been sent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shared Decision-making for Breast Cancer Screening in Primary Care
Shared decision-making for organised breast cancer screening (OBCS) could be improved by fostering interaction and exchanges of information between women and General Practitioners (GPs), for instance by including an assistance tool in the dispatch of the invitation letter for Organised Screening for breast cancer. In 2018 the national cancer Institute funded the development of a decisional aid (DA) on the theme of whether or not to take part in breast cancer screening, specific to the French setting. It is the website lamammo-etvous.fr DEDICACES project 1.
DEDICACES 2 is a population-based trial with a cluster design. It studies humans, without modifying their usual care. The experiment assesses the effect of the lamammo-etvous.fr/ tool on the decision to take part (or not) in OBCS among women who are invited for screening.
- Conditions
- Breast Cancer
- Being tested
- The decidons ensemble (let's decide together) leaflet and the https://lamammo-etvous.fr/ (let's talk about breast cancer screening) online tool.
- Keywords
- Breast cancer screening, Organized screening, General practitioner, Randomized controlled trial, Shared medical decision-making, Decisional aid, Primary health care
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The decidons ensemble (let's decide together) leaflet and the https://lamammo-etvous.fr/ (let's talk about breast cancer screening) online tool.Other
The leaflet will include a link to access the https://lamammo-etvous.fr DA aid tool, and will inform women about shared decision-making.
The GPs of women who are sent the leaflet will also be sent a letter encouraging shared decision-making. This material will be sent 3 months after women have received their breast cancer screening invitation letter.
Data related to primary and secondary objectives will be collected by questionnaire from the 2 groups. The questionnaire will be sent 2 months after participants are informed about the tool.
| Study group | Role | What they receive |
|---|---|---|
| Decisional aid for organised cancer screening | Experimental | Women will receive a leaflet that presents the tool. The leaflet includes a link to access the tool, and encourages the person to consult their GP to initiate the shared decision-making process. GPs will receive a letter presenting the study that includes: a) information about shared decision-making and how to implement it; b) the letter that is sent to their patients, and c) a recommendation to implement shared decision-making with their patients. Receives: Other: The decidons ensemble (let's decide together) leaflet and the https://lamammo-etvous.fr/ (let's talk about breast cancer screening) online tool. |
| Standard organised cancer screening | No intervention | Women and their GPs will continue to carry out usual screening. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the effectiveness of the /lamammo-etvous.fr/ DA tool on decision-making concerning the choice of whether or not to participate in OBCS among women who are invited for screening.
Overall score on the 16-item Decisional Conflict Scale (DCS). Measured 2 months after participants are informed about the tool, in both arms. 5 response categories: 1 = strongly agree; 5 = strongly disagree. Scores range from 0 [no decisional conflict] to 100 [extremely high decisional conflict].
Measured: 2 months
Secondary outcomes (5)
Evaluation of the effect of the presentation of the /lamammo-etvous.fr/ tool on the intention to participate in OBCS.
Score on a one-item (Measures of Decision) scale measuring intention to participate in OBCS. Measured 2 months after participants are informed about the tool, in both arms. Respondents check a box lying on a 15-point scale ranging from "I wish to participate in breast cancer screening" to "I do not wish to participate in breast cancer screening", with "I'm not sure" in the middle. Scores will be reclassified as follows: 1-5 (yes); 6-10 (unsure); 11-15 (no).
Measured: 2 months
Evaluation of the effect of presenting the /lamammo-etvous.fr/ DA tool on the implementation of shared decision-making.
Scores on the 9-item Shared Decision Making Questionnaire (SDM Q9). Measured 2 months after presentation of the tool, in both arms. Six response categories: 10 = completely disagree; 5 = completely agree. Scores are reported on a scale ranging from 0 (the lowest possible level of SDM) to 100 ( the highest extent of SDM).
Measured: 2 months
Evaluation of the effect of presenting the /lamammo-etvous.fr/ DA tool on women's knowledge of OBCS.
Number of correct responses to a 10-item questionnaire that tests OSBC-related knowledge. The questionnaire was developed in the context of the DEDICACES project (part 1) and is based on items included in the IPDAS (International Patient Decision Aid Standards) score. Measured 2 months after presentation of the support tool, in both arms.
Measured: 2 months
Evaluation of the effect of the presentation of the /lamammo-etvous.fr/ DA tool on women's care pathways following an invitation to participate in OBCS.
Data related to care pathways 2 months after presentation of the DA tool, in both arms: mammograms completed; appointments made to undergo mammography; appointments made to discuss screening; type of professionals contacted by participants (GP, midwife, gynaecologist, other).
Measured: 2 months
Evaluation of the effect of presenting the /lamammo-etvous.fr/ DA tool on decisional conflict in subgroups characterized by lower participation in OBCS.
Collection of socio-demographic patient data (home, work, marital status, in receipt of state aid) and health data (long-term illness, history of participation in OBCS, history of participation in colon cancer screening). Data collected 2 months after presentation of the DA tool, in both arms.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start16 Apr 2025
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 20,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France, Nantes University
- Responsible party
- Sponsor
- Investigators
- Cédric Rat, M.D. PhD., Study director, Nantes University Hospital, Faculty of medicine, General Practice Department, Nantes, FranceSandrine Hild, M.D., Principal investigator, Nantes University Hospital, Faculty of medicine, General Practice Department, Nantes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607849
- Sponsor's protocol ID
- RC20_0532
- Other IDs
- 2024-A00987-40
- Acronym
- DEDICACES2
- Status last verified
- Sep 2025
- First submitted
- 24 Oct 2022
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hild S, Teigne D, Ferrat E, Banaszuk AS, Berquet K, Lebon A, Bataille E, Nanin F, Gaultier A, Rat C. Breast cancer: a randomized controlled trial assessing the effect of a decision aid on mammography screening uptake: study protocol. Front Oncol. 2023 Apr 24;13:1128467. doi: 10.3389/fonc.2023.1128467. eCollection 2023.
PubMed 37168386
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision-making for Breast Cancer Screening in Primary Care
- ClinicalTrials.gov ID
- NCT05607849
- Acronym / sponsor ID
- DEDICACES2 / RC20_0532
- Conditions
- Breast Cancer
- Keywords
- Breast cancer screening, Organized screening, General practitioner, Randomized controlled trial, Shared medical decision-making, Decisional aid, Primary health care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20,000 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute, France, Nantes University
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 7 Nov 2022 (actual)
- 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.
Shared decision-making for organised breast cancer screening (OBCS) could be improved by fostering interaction and exchanges of information between women and General Practitioners (GPs), for instance by including an assistance tool in the dispatch of the invitation letter for Organised Screening for breast cancer. In 2018 the national cancer Institute funded the development of a decisional aid (DA) on the theme of whether or not to take part in breast cancer screening, specific to the French setting. It is the website lamammo-etvous.fr DEDICACES project 1.
DEDICACES 2 is a population-based trial with a cluster design. It studies humans, without modifying their usual care. The experiment assesses the effect of the lamammo-etvous.fr/ tool on the decision to take part (or not) in OBCS among women who are invited for screening.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Decisional aid for organised cancer screening | Experimental | Other: The decidons ensemble (let's decide together) leaflet and the https://lamammo-etvous.fr/ (let's talk about breast cancer screening) online tool.Women will receive a leaflet that presents the tool. The leaflet includes a link to access the tool, and encourages the person to consult their GP to initiate the shared decision-making process. GPs will receive a letter presenting the study that includes: a) information about shared decision-making and how to implement it; b) the letter that is sent to their patients, and c) a recommendation to implement shared decision-making with their patients. |
| Standard organised cancer screening | No intervention | –Women and their GPs will continue to carry out usual screening. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- General practitioners (GPs):
- 1) Practicing in one of the French départements (administrative area) covered by the study.
- Women:
- Invited to participate in OBCS by the National Health Insurance Agency (Caisse Nationale d'Assurance Maladie; CNAM) during the studied month: eligible for OBCS, therefore aged between 50 and 74 at the time of inclusion;
- On the patient list of a GP who is covered by the study at the time of inclusion;
Key exclusion criteria (15 listed)
- General practitioners (GPs) :
- Those who do not have any patients invited for OBCS in the studied month;
- Those whose practice does not correspond to the usual activities of a GP (known as a Mode d'Exercice Particulier), or who have very few patients (who have seen fewer than 100 different patients in the year preceding the experiment);
- Those who practice within a health centre (as it is impossible to evaluate the activity of an individual practitioner in health insurance databases);
- Those who explicitly state that they do not want to take part in the study, in response to an initial letter of invitation. This letter will inform them that the study is being run, and will inform them of the option to refuse to participate if they so wish;
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 |
|---|---|---|
| The decidons ensemble (let's decide together) leaflet and the https://lamammo-etvous.fr/ (let's talk about breast cancer screening) online tool.The leaflet will include a link to access the https://lamammo-etvous.fr DA aid tool, and will inform women about shared decision-making. The GPs of women who are sent the leaflet will also be sent a letter encouraging shared decision-making. This material will be sent 3 months after women have received their breast cancer screening invitation letter. Data related to primary and secondary objectives will be collected by questionnaire from the 2 groups. The questionnaire will be sent 2 months after participants are informed about the tool. | Other | Decisional aid for organised cancer screening |
Primary outcome
Evaluation of the effectiveness of the /lamammo-etvous.fr/ DA tool on decision-making concerning the choice of whether or not to participate in OBCS among women who are invited for screening.
Time frame: 2 months
Overall score on the 16-item Decisional Conflict Scale (DCS). Measured 2 months after participants are informed about the tool, in both arms. 5 response categories: 1 = strongly agree; 5 = strongly disagree. Scores range from 0 [no decisional conflict] to 100 [extremely high decisional conflict].
5 secondary outcomes
Evaluation of the effect of the presentation of the /lamammo-etvous.fr/ tool on the intention to participate in OBCS.
Time frame: 2 months
Evaluation of the effect of presenting the /lamammo-etvous.fr/ DA tool on the implementation of shared decision-making.
Time frame: 2 months
Evaluation of the effect of presenting the /lamammo-etvous.fr/ DA tool on women's knowledge of OBCS.
Time frame: 2 months
Evaluation of the effect of the presentation of the /lamammo-etvous.fr/ DA tool on women's care pathways following an invitation to participate in OBCS.
Time frame: 2 months
Evaluation of the effect of presenting the /lamammo-etvous.fr/ DA tool on decisional conflict in subgroups characterized by lower participation in OBCS.
Time frame: 2 months
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 25 Sep 2026.
- Derived from this study: PubMed 37168386Hild S, Teigne D, Ferrat E, Banaszuk AS, Berquet K, Lebon A, Bataille E, Nanin F, Gaultier A, Rat C. Breast cancer: a randomized controlled trial assessing the effect of a decision aid on mammography screening uptake: study protocol. Front Oncol. 2023 Apr 24;13:1128467. doi: 10.3389/fonc.2023.1128467. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Cédric Rat, M.D. PhD. study director
Nantes University Hospital, Faculty of medicine, General Practice Department, Nantes, France
Sandrine Hild, M.D. principal investigator
Nantes University Hospital, Faculty of medicine, General Practice Department, Nantes, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The decidons ensemble (let's decide together) leaflet and the https://lamammo-etvous.fr/ (let's talk about breast cancer screening) online tool. in people with Breast Cancer, run by Nantes University Hospital 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 8 inclusion and 15 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 25 Sep 2026. 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?
Evaluation of the effectiveness of the /lamammo-etvous.fr/ DA tool on decision-making concerning the choice of whether or not to participate in OBCS among women who are invited for screening. (time frame: 2 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 NCT05607849, which also lists 1 linked publication.
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 25 Sep 2026.