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Breast Cancer Screening Uptake: a Randomized Controlled Trial Assessing the Effect of a Decisional Aid

Study acronym: DEDICACES2
StatusCompleted
PhaseNot applicable
Started2025-04-16
View on ClinicalTrials.gov ↗

Amendment history

2026-09-26
critical
Completed without a posted recruiting period
Primary endpoint(s) modified1 entry, revised
WasEvaluation of the effectiveness of the discutons-mammo.fr DA tool on decision-making concerning the choice of whether or not to participate in OBCS among women who are invited for screening.
NowEvaluation 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.
Primary completion confirmed: September 2025 (last estimated June 2025)
Interventions modified
2024-11-13
minor
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Primary completion date2024-09-01→2025-06-01
Completion date2025-01-01→2025-09-01
Start date2023-01-01→2024-12-01
Enrollment target66000→20000
InterventionsLeaflet "decidons ensemble" (making a decision together) (Other)→The decidons ensemble (let's decide together) leaflet and the discutons-mammo.fr (let's talk about breast cancer screening) online tool…
Eligibility criteria+1,051 characters
Inclusion Criteria : - General practitioners (GPGPs): The Allfollowing GPs practisingwill 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: e [...] in the 5participating Frenchdepartments. Exclusion departementsCriteria Maine: -et-Loire General practitioners (GPs) : The following GPs will be excluded: Those who do not have any patients invited for OBCS in the [...] [...]
Secondary endpoints5 entries, revised
DescriptionEvaluation of the factorseffect associatedof withthe presentation of the discutons-mammo.fr tool on the intention to participate in OBCS. Evaluation of the effect of presenting the discutons-mammo.fr DA tool on the implementation of shared decision-making. Evaluation of the effect of presenting the discutons-mammo.fr DA tool on women's knowledge o [...] lower participation in screening Description of the implementation and the quality of shared decision processes for the 4 months after dispatch of the letter, from a sample of women included in the two arms, irrespective of whether or not [...] [...]
Primary endpoints1 entry, revised
ParticipationEvaluation of the effectiveness of the discutons-mammo.fr DA tool on decision-making concerning the choice of whether or not to participate in organisedOBCS screeningamong women who are invited for breast cancerscreening.
Collaborators1 to 2 entries
Nantes University hospital, Research Department
2022-11-02
minor
Original filing
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.
Trial Details
NCT Number NCT05607849
Lead Sponsor Nantes University Hospital
Collaborators: National Cancer Institute, France, Nantes University
Conditions Breast Cancer
Enrollment 20,000 participants
Start Date 2025-04-16
Primary Completion 2025-09-15 (estimated)
Study Completion 2025-09-15 (estimated)
Updated on ClinicalTrials.gov 2026-09-25