EXPérimentation d'Envoi Postal DIrect à Domicile du kiT de dépistage du Cancer Colorectal Sans Commande préalable [Trial of Direct Home Delivery of Colorectal Cancer Screening Kit Without Pre-ordering]
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 64,000
- 试验地点
- 1
- 主要终点
- Performance of colonoscopy in FIT positive patients
研究概览
简要总结
The effect of mailing FIT with the invitation on participation and colonoscopy rates will be evaluated in a randomized controlled trial conducted in the Centre-Val de Loire (CVL) region, involving 64,000 people from the population eligible for colorectal cancer population-based organised screening program (CRC-PBOSP).
In the "C" control group, invitations, test delivery and reminders will be carried out in accordance with the CRC-PBOSP rules at the time of the study.
Intervention group "B" will evaluate two experimental modes of invitation with direct home mailing of the test:
- Method "B1": invitation with test sent to home without prior information letter
- Method "B2": information letter followed by invitation with test sent home, designed to optimize participation by first-time subjects (aged 50-51) invited to the CRC-PBOSP for the first time.
Ancillary studies will focus 1/ on acceptability of this intervention (qualitative study on a few general practitioners, gastroenterologists and invitees), 2/ on social and geographical inequalities of participation on a subsample of individuals included in EXPEDIT study using ecological indices (EDI, SCALE).
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 to 74 years old
- •Resident of Centre Val de Loire French area
- •Eligible for CRC screening invitation within the biennal CRC-PBOSP during the inclusion period
- •Affiliated to the health insurance scheme
排除标准
- •CRC screening exclusion criteria notified to CRCDC-CVL in a previous screening round (family or personal history of CRC/adenoma, inflammatory bowel disease)
- •Colonoscopy in the previous 5 years)
- •Subjects refusing data transmission to research team will be excluded from statistical analyses.
研究组 & 干预措施
Control "C"
Usual care : Screening test (Fecal immunochemical test - FIT) delivery and reminders will be carried out in accordance with the Colorectal cancer population-based organised screening program (CRC-PBOSP) specifications at the time of the study.
This arm is suitable for both the first screening round in 50-51 years old population, and for the subsequent screening rounds.
干预措施: CRC screening invitation not including the screening test. (Other)
Intervention "B1"
FIT mailed at home within the CRC screening invitation without prior information letter.
This arm is suitable for both the first screening round in 50-51 years old population, and for the subsequent screening rounds.
干预措施: Mailing of FIT with invitation (Other)
Intervention "B2"
FIT mailed at home within the CRC screening invitation with prior information letter.
This arm is suitable for the first screening round in 50-51 years old population only.
干预措施: Mailing of FIT with invitation (Other)
Intervention "B2"
FIT mailed at home within the CRC screening invitation with prior information letter.
This arm is suitable for the first screening round in 50-51 years old population only.
干预措施: Information letter before invitation (Other)
结局指标
主要结局
Performance of colonoscopy in FIT positive patients
时间窗: 6 months after the positive FIT
Rate of Colonoscopy within 6 months after positive FIT among invitees with a positive FIT
Participation to CRC screening program
时间窗: 16 months after the invitation
Rate of FIT sent to laboratory for analysis within 16 of months of invitation among invitees.
次要结局
- Colonoscopy findings(12 months after the positive test)
- Time to screening participation(24 months after invitation)
- Participation to CRC screening program at 24 months(24 months after invitation)
- Colonoscopy in FIT positive patients, 12 months after the positive test(12 months after the positive test)
- Time to colonoscopy (in FIT positive patients)(12 months after the positive test)
- Participation to CRC screening program in first invitees (50-51 yrs-old)(16 months after invitation)
- Cost-effectiveness analysis(24 months)