U1086 INSERM "ANTICIPE" Caen Normandy University - Equipe Labellisée Ligue, Contre le Cancer, Caen, France.
Centre de lutte contre le cancer François Baclesse, Caen, France.
Trials. 2022 Jul 8;23(1):562. doi: 10.1186/s13063-022-06480-w.
Breast cancer is the leading cancer in women in France both in incidence and mortality. Organized breast cancer screening (OBCS) has been implemented nationwide since 2004, but the participation rate remains low (48%) and inequalities in participation have been reported. Facilities such as mobile mammography units could be effective to increase participation in OBCS and reduce inequalities, especially areas underserved in screening. Our main objective is to evaluate the impact of a mobile unit and to establish how it could be used to tackle territorial inequalities in OBCS participation.
A collaborative project will be conducted as a randomized controlled cluster trial in 2022-2024 in remote areas of four French departments. Small geographic areas were constructed by clustering women eligible to OBCS, according to distance to the nearest radiology centre, until an expected sample of eligible women was attained, as determined by logistic and financial constraints. Intervention areas were then selected by randomization in parallel groups. The main intervention is to propose an appointment at the mobile unit in addition to current OBCS in these remote areas according to the principle of proportionate universalism. A few weeks before the intervention, OBCS will be promoted with a specific information campaign and corresponding tools, applying the principle of multilevel, intersectoral and community empowerment to tackle inequalities.
This randomized controlled trial will provide a high level of evidence in assessing the effects of mobile unit on participation and inequalities. Contextual factors impacting the intervention will be a key focus in this evaluation. Quantitative analyses will be complemented by qualitative analyses to investigate the causal mechanisms affecting the effectiveness of the intervention and to establish how the findings can be applied at national level.
Registered on ClinicalTrials.gov, December 21, 2021: NCT05164874 .
在法国,乳腺癌无论是在发病率还是死亡率方面都是女性中最常见的癌症。自 2004 年以来,全国范围内已经开展了有组织的乳腺癌筛查(OBCS),但参与率仍然较低(48%),而且存在参与不平等的情况。移动乳房 X 光筛查车等设施可能有助于提高 OBCS 的参与率并减少不平等现象,尤其是在筛查服务不足的地区。我们的主要目标是评估移动筛查车的效果,并确定如何利用它来解决 OBCS 参与方面的地域不平等问题。
该研究将在 2022 年至 2024 年期间在法国四个省的偏远地区进行一项协作项目,作为一项随机对照集群试验。根据距离最近放射学中心的距离,对符合 OBCS 条件的女性进行小地理区域聚类,直到根据逻辑和财务限制达到预期的符合条件的女性样本量。然后通过随机分组的方式选择干预区域。主要干预措施是根据比例普遍性原则,在这些偏远地区的移动筛查车中除了当前的 OBCS 之外,再为女性预约。在干预前几周,将开展 OBCS 宣传活动,并提供相应的工具,应用多层次、跨部门和社区赋权的原则来解决不平等问题。
这项随机对照试验将提供高水平的证据,评估移动筛查车对参与率和不平等的影响。评估将重点关注影响干预的背景因素。定量分析将辅以定性分析,以研究影响干预效果的因果机制,并确定如何将研究结果应用于国家层面。
于 2021 年 12 月 21 日在 ClinicalTrials.gov 上注册:NCT05164874。