Breast Cancer Screening Uptake: a Randomized Controlled Trial Assessing the Effect of a Decisional Aid
NCT ID: NCT05607849
Last Updated: 2024-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20000 participants
INTERVENTIONAL
2024-12-01
2025-09-01
Brief Summary
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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 discutons-mammo.fr tool on the decision to take part (or not) in OBCS among women who are invited for screening.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Decisional aid for organised cancer screening
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.
The decidons ensemble (let's decide together) leaflet and the discutons-mammo.fr (let's talk about breast cancer screening) online tool.
The leaflet will include a link to access the discutons-mammo.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.
Standard organised cancer screening
Women and their GPs will continue to carry out usual screening.
No interventions assigned to this group
Interventions
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The decidons ensemble (let's decide together) leaflet and the discutons-mammo.fr (let's talk about breast cancer screening) online tool.
The leaflet will include a link to access the discutons-mammo.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.
Eligibility Criteria
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Inclusion Criteria
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:
1. 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;
2. On the patient list of a GP who is covered by the study at the time of inclusion;
3. Covered by one of the CPAM (Caisse Primaire d'Assurance Maladie) in the participating departments.
Exclusion Criteria
The following GPs will be excluded:
1. Those who do not have any patients invited for OBCS in the studied month;
2. 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);
3. Those who practice within a health centre (as it is impossible to evaluate the activity of an individual practitioner in health insurance databases);
4. 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;
5. 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:
1. Participants in the MyPEBS study ( the only national study of OBCS at the time the present protocol was drawn up); or,
2. If their GP refuses to participate in the study; or,
3. 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.
50 Years
74 Years
FEMALE
No
Sponsors
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National Cancer Institute, France
OTHER_GOV
Nantes University hospital, Research Department
UNKNOWN
Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Cédric Rat, M.D. PhD.
Role: STUDY_DIRECTOR
Nantes University Hospital, Faculty of medicine, General Practice Department, Nantes, France
Sandrine Hild, M.D.
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital, Faculty of medicine, General Practice Department, Nantes, France
Central Contacts
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References
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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.
Other Identifiers
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2024-A00987-40
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
RC20_0532
Identifier Type: -
Identifier Source: org_study_id
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