Three Birds With One Stone: a Randomised Intervention Study to Increase Participation in Cervical and Colorectal Cancer Screening Among Women Attending Breast Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27,099
- 试验地点
- 2
- 主要终点
- Coverage
研究概览
简要总结
The overall aim of the study is to increase participation rates in cervical cancer (CCU) and colorectal cancer (CRC) screening programmes in Denmark by offering home-based CCU and CRC screening to women who are overdue for one or both screening programmes when attending breast cancer screening
详细描述
A cluster-randomised public health trial will take place in Central Denmark Region (CDR) targeting women attending breast cancer screening. Five breast cancer screening units serve women five days a week, and all five units will be included in the study and randomly allocated to an equal amount of intervention days. On the intervention days, the other four units will serve as the control group, providing a randomisation ratio of 1:4.
On the intervention days, a research assistant will ask the women aged 50-69 years if they are interested in having a check up on their screening status with CCU and CRC screening. If the woman has not participated timely, she will be offered to receive a test-kit corresponding to CRC screening and/or to receive a self-sample device for CCU screening (or reminded to call her general practitioner (GP) to have a conventional cervical cytology sample taken).
If the woman accepts a self-sample kit for CCU and/or CRC screening, she will receive it by mail together with written instructions, picturebased user instructions, information on national recommendation for cancer screening and a pre-paid, pre-addressed envelope for returning the sample to the laboratory.
The result of the test will be sent to the women by digital mail as well as passed on to her GP.
Clinical management in case of a positive test result will follow national guidelines corresponding to CCU and CRC screening programmes.
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
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 50-69 years attending breast cancer screening in Central Denmark Region on selected days.
- •In CCU screening: women aged 50-64 years will be classified as overdue if they have not had a cervical sample within the last 5 years and 6 months
- •In CRC screening: women aged 50-69 years will be classified as overdue, if they have not had a FIT within the last 2 years and 4.5 months despite an invitation.
排除标准
- 未提供
结局指标
主要结局
Coverage
时间窗: 180 days after participating in breast cancer screening
Difference in overall coverage og CCU/CRC screening six months after the intervention between control and intervention group
Participation
时间窗: 180 days after participating in breast cancer screening
Difference between intervention and control group in proportion of women participating in CCU and CRC screening after 180 days for those overdue with CCU/CRC screening at the intervention
次要结局
- Incidence of CIN2+(Within 180 days after a positive hrHPV self-sample)
- Rate of compliance to follow-up in CCU screening(Within 180 days after a positive hrHPV self-sample)
- Histology (number of adenomas, cancer) after a positive FIT in CRC screening(After test completion, expected to be 1 year)
- Prevalence of hrHPV in self-samples in CCU screening(After study completion, expected to be 1 year)
- Register-based screening history of self-samplers in CCU screening(After test completion. expected to be 1 year)
- Incidence of hrHPV positive cases in women 60-64 years after 12 months with an initial negative hrHPV sample in CCU screening(After test completion, expected to be 1 year)
- Prevalence of positive FIT cases after CRC screening for those overdue at the intervention date(After test completion, expected to be 1 year)
- Prevalence of colposcopies after CCU screening(Within 180 days after a positive hrHPV self-sample)
- Register-based screening history in CRC screening(After test completion, expected to be 1 year)
- Rate of compliance to follow-up with colonoscopy after a positive FIT(Within 60 days from a positive FIT)