Breast Cancer Screening Uptake: a Randomized Controlled Trial Assessing the Effect of a Decisional Aid
- Conditions
- Breast Cancer
- Interventions
- Other: Leaflet "decidons ensemble" (making a decision together)
- Registration Number
- NCT05607849
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 20000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Decisional aid for organised cancer screening Leaflet "decidons ensemble" (making a decision together) 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.
- Primary Outcome Measures
Name Time Method 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. 2 months Overall score on the 16-item Decisional Conflict Scale (DCS). Measured 2 months after participants are informed about the tool, in both arms. 5 response categories: 1 = strongly agree; 5 = strongly disagree. Scores range from 0 \[no decisional conflict\] to 100 \[extremely high decisional conflict\].
- Secondary Outcome Measures
Name Time Method Evaluation of the effect of presenting the discutons-mammo.fr DA tool on women's knowledge of OBCS. 2 months Number of correct responses to a 10-item questionnaire that tests OSBC-related knowledge. The questionnaire was developed in the context of the DEDICACES project (part 1) and is based on items included in the IPDAS (International Patient Decision Aid Standards) score. Measured 2 months after presentation of the support tool, in both arms.
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. 2 months Data related to care pathways 2 months after presentation of the DA tool, in both arms: mammograms completed; appointments made to undergo mammography; appointments made to discuss screening; type of professionals contacted by participants (GP, midwife, gynaecologist, other).
Evaluation of the effect of presenting the discutons-mammo.fr DA tool on decisional conflict in subgroups characterized by lower participation in OBCS. 2 months Collection of socio-demographic patient data (home, work, marital status, in receipt of state aid) and health data (long-term illness, history of participation in OBCS, history of participation in colon cancer screening). Data collected 2 months after presentation of the DA tool, in both arms.
Evaluation of the effect of the presentation of the discutons-mammo.fr tool on the intention to participate in OBCS. 2 months Score on a one-item (Measures of Decision) scale measuring intention to participate in OBCS. Measured 2 months after participants are informed about the tool, in both arms. Respondents check a box lying on a 15-point scale ranging from "I wish to participate in breast cancer screening" to "I do not wish to participate in breast cancer screening", with "I'm not sure" in the middle. Scores will be reclassified as follows: 1-5 (yes); 6-10 (unsure); 11-15 (no).
Evaluation of the effect of presenting the discutons-mammo.fr DA tool on the implementation of shared decision-making. 2 months Scores on the 9-item Shared Decision Making Questionnaire (SDM Q9). Measured 2 months after presentation of the tool, in both arms. Six response categories: 10 = completely disagree; 5 = completely agree. Scores are reported on a scale ranging from 0 (the lowest possible level of SDM) to 100 ( the highest extent of SDM).