Randomized Controlled Trial to Study Interventions to Increase Participation in Cervical Cancer Screening Program
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8,800
- 主要终点
- Frequency of testing (cytology in arm A and C and HPV-test in arm B). F
研究概览
简要总结
Women who don't participate in Swedish cytology screening program are a minority of about 10%, but constitute the majority of those who acquire cervical cancer. Over 50 000 women in the Västra Götalandregion have abstained from participation in the program for at least 2 screening rounds (6 - 10 years, depending om age). We plan to test two promising strategies to increase participation. In a study of two different health policies women who have defaulted are randomised to receiving a telephone call from a midwife, receive an offer of a self-test for HPV or being included in a control group. This is an effectiveness study that should give an answer how participation could be increased and give the basis for a calculation of the costs involved, before decisions can be made about implementing either intervention.
详细描述
Background
Cervical cancer today is considered as a disease that to a very large extent is preventable. In Sweden cytological screening has been ongoing since the 60:s and this has made cervical cancer a rare disease. Several new, but costly, methods like HPV-testing and vaccination has been claimed to further reduce cancer incidence, but this has not been scientifically proven so far. A recent audit of the Swedish screening program (Andrae 2008) found that the foremost risk factor for cervical cancer in the context of the program was non participation. Women who do participate are well protected from cervical cancer.
A Swedish study evaluating different strategies to increase participation found telephone contact with defaulters to be the superior intervention (Eaker 2004). This study was done in a region of Sweden with lower coverage (Sparén 2007) and less emphasis on efforts to increase participation. A study from Kalmar, Sweden, with high coverage did not find an extended yield to requests from non-participating women to be cost effective (Oscarsson 2007). Self testing for HPV has been advocated as an effective method and there is a kit commercially available (Stenvall 2007). The procedure is used as a routine in Uppsala county and marketed to other counties.
Aim To study two possible interventions to increase participation
Design Randomised controlled trials of two interventions and a control arm
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
- Single (Care Provider)
入排标准
- 年龄范围
- 29 Years 至 63 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •No record of PAP smear in the regional screening register for more than two screening rounds (6 - 10 years depending on age).
- •Evidence in the regional population register that women have been living in the west region of Sweden during this time.
排除标准
- •Total hysterectomy
结局指标
主要结局
Frequency of testing (cytology in arm A and C and HPV-test in arm B). F
时间窗: 7 months after invitation
Frequency of further assessment of abnormal tests
时间窗: 7 months
次要结局
- Frequency of abnormal smears. (Arm A vs arm C)(7 months)
- Frequency of treated CIN (Arm A vs. arm C)(7 months)
- Number of invasive cancers detected classified by FIGO stadium.(7 months)
- Cost of interventions(7 months)
- Cost per CIN2+ found and treated(7 months)