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

Breast Cancer Clinical Trial

— DEDICACES2  

Official title:

Shared Decision-making for Breast Cancer Screening in Primary Care

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05607849
• Other study ID #: RC20_0532
• Secondary ID: 2021-A01583-38
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: October 2022
• Source: Nantes University Hospital
• Contact: Cédric Rat, M.D. PhD.
• Phone: 02 40 41 28 28
• Email: cedric.rat[@]univ-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66000
• Est. completion date: January 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Leaflet "decidons ensemble" (making a decision together)
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	National Cancer Institute, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participation in organised screening for breast cancer	Participation rate for organised screening for breast cancer in each study arm for the 18 months after dispatch of the letter	18 months
Secondary	Description of the factors associated with lower participation in screening	Participation rate for organised breast cancer screening, in each study arm for the 18 months after dispatch of the letter, according to patient age, socio-economic status, regularity of medical surveillance, the presence of chronic or psychiatric pathologies and previous participation in screening	18 months
Secondary	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 they underwent screening	Scores for the 9-items Shared Decision Making Questionnaire. (5 response categories ; number 1 = completely disagree ; number 5 = completerly agree ; higher scores mean better outcome).	4 months
Secondary	Description of the existence of decisional conflict for the 4 months after dispatch of the letter, from a sample of women included in the two arms, irrespective of whether or not they underwent screening	Scores for the 16-items Decisionnal Conflict Scale. (5 response categories ; number 1 = strongly agree ; number 5 = strongly disagree ; higher scores mean worse outcome).	4 months
Secondary	Description of intention to take part in organised screening for the 4 months after dispatch of the letter, from a sample of women included in the two arms, irrespective of whether or not they underwent screening	Responses to the intention to participate in screening Questionnaire (Questionnaire developed for the project ; 4 response categories = yes, no, don't know, don't want to answer).	4 months
Secondary	Description of the level of knowledge about organised screening for the 4 months after dispatch of the letter, from a sample of women included in the two arms, irrespective of whether or not they underwent screening	Responses to the knowledge questionnaire on organized screening (Questionnaire developed for the project ; 20 items , 3 response categories = true, false, dont know).	4 months