Efficacy of Offering a Self-sampling Device by the General Practitioner to Reach Women Underscreened in the Routine Cervical Cancer Screening Program Compared to Sending Reminder Letters by the Screening Organization
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3,375
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
The ESSAG trial invests the impact of offering a free self-sampling device (SSD) on the cervical cancer screening rate of underscreened women. This study is aimed at women between the age of 31 and 64 who did not have a smear taken during the last 6 years. In order to assess the effect of a) providing the SSD, and b) the intervention of the general practitioner (GP) (either face-to-face, either by sending the SSD by letter), a cluster randomized control trial is set up with three arms. The ESSAG trial evolves from a collaboration between Universiteit Gent and Vrije Universiteit Brussel, Katholieke Universiteit Leuven, Universiteit Antwerpen, Sciensano, het Centrum voor Kankeropsporing en het Belgisch Kankerregister, and is funded by "Kom Op Tegen Kanker".
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 31 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women between 31-64 years old
- •living in Flanders
- •eligible for the Flemish actions with regard to population screening
- •without a smear registered in the Belgian Cancer Registry in the last 6 years
- •registered as GMD patient in one of the participating GP practices
排除标准
- •hysterectomy
- •pregnancy
- •(past) diagnosis of cervical cancer
研究组 & 干预措施
A Self sampling device (SSD) provided by the general practitioner (GP)
A self sampling device will be provided by the GP.
干预措施: Provision of self sampling device by the GP (Other)
B Self sampling device provided by letter
A self sampling device will be provided by letter.
干预措施: Provision of self sampling device by letter (Other)
C (control arm) Recommendation letter
Following the usual care procedure, a random sample of 1125 Flemish women who meet the same inclusion criteria as in arm A and B and are not included in one of the latter arms is drawn by "Centrum voor Kankeropsporing" (CvKO) from Heracles, the database of the Flemish screening program.
结局指标
主要结局
Response rate
时间窗: Up to 6 months
Age-standardised response rates in each arm and the differences between arms will be calculated, in a per protocol (PP) and intention-to-treat (ITT) analysis. As the goal is to reveal to what extent the respective approach (providing a self sampling device (SSD) with different levels of general practitioner (GP) involvement) succeeds in reaching vulnerable women, analyses will take into account a comprehensive list of covariates by logistic regression accounting for cluster effects. These covariates include trial arm, GP-office characteristics, as well as demographic information of the patient on origin and socio-economical background provided by the "Kruispuntbank voor Sociale Zekerheid (KSZ)".
次要结局
- Response rate (follow-up cytology test)(Up to 3 months)
- Cost-effectiveness analysis(Up to 15 months)
- Feasibility analysis (semi-structured interviews with GP's)(Up to 4 months after the intervention in their practice)
- Participation rate(Up to 6 months)