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

Study Overview
=================
Brief 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

Official Title
-----------------
Shared Decision-making for Breast Cancer Screening in Primary Care

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: Leaflet decidons ensemble (making a decision together)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decisional aid for organised cancer screening<br>Eligible women will receive an invitation letter for a mammography accompanied by a leaflet mentioning the existence of the DA and encouraging them to consult their GP to initiate the DMP. The GPs will receive a letter informing them of the letter sent to their patients inviting them to make use of the DA, of the DA itself, and presenting the different stages in the DMP with encouragement to implement it. | Other: Leaflet decidons ensemble (making a decision together)<br>* 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.<br>|
| No Intervention: Standard organised cancer screening<br>Eligible women will receive only invitation letters, in line with national standard practice | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Shared medical decision-making, Breast cancer screening, Organized screening, General practitioner, Randomized controlled trial, Decisional aid, Primary health care