Cervical Cancer Screening Uptake: A Randomised Controlled Trial Assessing the Effect of Sending Invitation Letters to Nonadherent Women Combined With Sending Their General Practitioners a List of Their Nonadherent Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 195,000
- 试验地点
- 2
- 主要终点
- Proportion of women aged 40-65 who performed a screening test (HPV test or PAP smear) over the last 3 years, 6 months after the intervention
研究概览
简要总结
Context:
In France, cervical cancer (CC) screening was opportunistic until recently. The target population includes women aged 25 to 65 years. About 66% of women aged 25-40 years have performed a screening test over the last three years but this figure decreases to 55% in women over 40. The third "Cancer Plan" proposed by the French National Institute for Cancer recommends to achieve an 80% participation in eligible women.
Improving women compliance to CC screening is a major challenge to decrease cancer incidence and mortality.
To improve patient adherence, a CC screening organization will be launched in 2020 at a national scale in France. Women who did not perform a PAP test over the last 3 years will receive an invitation letter from the local public health association in charge of cancer screening organization. The invitation letter will remind women that they should consult a healthcare professional (a general practitioner (GP), a gynecologist or a midwife) to perform a screening test.
Providing GPs with a list of their non-adherent patients could also improve women compliance to CC screening recommendations.
The study objective is to assess whether sending both an invitation letter to non-adherent women and a list of their non-adherent patients to GPs ("invitation letter + GP reminder" group) could increase the proportion of women who perform a screening test, compared to only sending an invitation letter to non-adherent women ("invitation letter" group) or not sending any invitation ("usual care" group).
详细描述
Design, Setting and Participants:
The investigators will conduct a 3-arm, cluster-randomized, controlled trial in the Loire-Atlantique region, in France.
The study will include a total of 1,500 GPs and about 100,000 women. The randomization will be based on GP practices to avoid a contamination bias resulting from shared tracking mechanisms and communication between GPs within a given practice. Thus, several GPs working in the same practice will be assigned to the same study arm. Women on the patient list of a given GP will be assigned to the arm of this GP.
Intervention:
After a cluster randomization according to the practice, the GPs and their female patients will be included in one of the following 3 arms:
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Proportion of women aged 40-65 who performed a screening test (HPV test or PAP smear) over the last 3 years, 6 months after the intervention
时间窗: 6 months
次要结局
- Description of the results of screening tests carried out in first intention(6 months)
- Description of the types of tests performed for follow-up of lesions detected(6 months)
- Description of the factors associated with lower participation in screening(6 months)
- Description of the types of tests performed to follow lesions detected by screening(12 months)
- Description the results of the tests performed to follow lesions detected by screening(12 months)
- Description of the treatments undergone by the women following abnormal screening tests(12 months)
- Description of the healthcare trajectory of women undergoing a screening test(6 months)
- Description of the types of screening tests carried out in first intention(6 months)