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

Official title

Shared Decision-making for Breast Cancer Screening in Primary Care

Overview

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 Discutons-mammo.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 discutons-mammo.fr tool on the decision to take part (or not) in OBCS among women who are invited for screening.

Interventions

• Other 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 par

Primary outcome measures

• Evaluation 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. [Time frame: 2 months]

Secondary outcome measures (5)

• Evaluation of the effect of the presentation of the discutons-mammo.fr tool on the intention to participate in OBCS. [Time frame: 2 months]
• Evaluation of the effect of presenting the discutons-mammo.fr DA tool on the implementation of shared decision-making. [Time frame: 2 months]
• Evaluation of the effect of presenting the discutons-mammo.fr DA tool on women's knowledge of OBCS. [Time frame: 2 months]
• Evaluation of the effect of the presentation of the discutons-mammo.fr DA tool on women's care pathways following an invitation to participate in OBCS. [Time frame: 2 months]
• Evaluation of the effect of presenting the discutons-mammo.fr DA tool on decisional conflict in subgroups characterized by lower participation in OBCS. [Time frame: 2 months]

Eligibility criteria

Inclusion criteria

\- General practitioners (GPs):

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:

• 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;
• On the patient list of a GP who is covered by the study at the time of inclusion;
• Covered by one of the CPAM (Caisse Primaire d'Assurance Maladie) in the participating departments.

Exclusion criteria

\- General practitioners (GPs) :

The following GPs will be excluded:

• Those who do not have any patients invited for OBCS in the studied month;
• 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);
• Those who practice within a health centre (as it is impossible to evaluate the activity of an individual practitioner in health insurance databases);
• 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;
• 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:

• Participants in the MyPEBS study ( the only national study of OBCS at the time the present protocol was drawn up); or,
• If their GP refuses to participate in the study; or,
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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. PMID 37168386

Identifiers

NCT: NCT05607849 · RC20_0532 · 2024-A00987-40

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗