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Trial Title:
Breast Cancer Screening Uptake: a Randomized Controlled Trial Assessing the Effect of a Decisional Aid
NCT ID:
NCT05607849
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast cancer screening
Organized screening
General practitioner
Randomized controlled trial
Shared medical decision-making
Decisional aid
Primary health care
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Parallel Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Leaflet "decidons ensemble" (making a decision together)
Description:
At the beginning of the intervention, material i) informing women of the existence of the
DA for participation or not in breast cancer screening and (ii) aiming to promote the
implementation of shared medical decision will be sent or not sent to women and their GPs
according to their allocation arm. This material will be sent at the same time as the
breast cancer screening invitation letter.
For the secondary outcomes, questionnaires will be sent to a sample of women in each arm.
Arm group label:
Decisional aid for organised cancer screening
Summary:
Shared decision-making for organised breast cancer screening could be improved by
fostering interaction and exchanges of information between women and GPs, for instance by
including an assistance tool in the dispatch of the invitation letter for Organised
Screening (OS) 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
Discutons-mammo.fr DEDICACES project 1.
DEDICACES 2 is a pragmatic, non-inferiority, population-based trial with a cluster
design. The aim is to assess the impact of the dispatch of a leaflet informing women of
the existence of the DA Discutons-mammo.fr on the uptake by eligible women of breast
cancer screening in an organised setting in usual practical conditions and in the general
population
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- General practitioners (GP) All GPs practising in the 5 French departements
Maine-et-Loire, Mayenne, Sarthe, Loire Atlantique and Vendee having seen more than
100 different patients in the year before baseline, will be eligible.
- Patients
- aged de 50 to 74 yrs
- affiliated to the French health insurance CPAM
- residing in one of the 5 departments
- eligible for organised screening for the month(s) under consideration
- whose GP is included in the study
Exclusion Criteria:
- General practitioners (GPs) :
- Refusal to participate
- Participants in other studies on breast cancer screening
- Practising in a health centre
- Patients
- Refusal to participate
- Having a GP who refuses to take part
- Affiliated to a Health Centre
- Taking part in other studies on breast cancer screening
- Being under guardianship
- Presently followed for a condition that might interfere with organised
screening (breast cancer, anomaly, medical surveillance or women with high risk
- Having a history of breast cancer
Gender:
Female
Minimum age:
50 Years
Maximum age:
74 Years
Healthy volunteers:
No
Start date:
January 1, 2023
Completion date:
January 1, 2025
Lead sponsor:
Agency:
Nantes University Hospital
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute, France
Agency class:
Other
Source:
Nantes University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05607849
