Efficacy of Strategies Involving Self-sampling to Reach Women Not Participating in Regular Cervic… (NCT05243888) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Efficacy of Strategies Involving Self-sampling to Reach Women Not Participating in Regular Cervical Cancer Screening
France15,000 participantsStarted 2022-03-09
Plain-language summary
The cervical cancer screening coverage remains moderate (60%) in France. The aim of the study is to evaluate the efficacy of two experimental invitation strategies (offer of urine or vaginal self-sampling kits) to reach under-screened populations and compare them with the current invitation strategy in rural departments (low medical density and low participation rate) in France.
The study is a randomised controlled trial with three arms: a control arm (conventional invitation letter) and two experimental arms (mailing of a urine or vaginal self-sampling kit). The target population includes women aged 30-65 years, who had no screening test recorded since more than four years and who did not respond to an invitation letter within twelve months before. The primary outcome measure is the participation rate in each arm.
A team of psychologists will also investigate attitudes and experiences by semi-structured/focus-group interviews with voluntary CapU4 participants and with health professionals.
CapU4 will identify effective strategies to reach women not responding to current screening invitations and will generate information about acceptance of self-sampling among women and health professionals.
Who can participate
Age range
30 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* women aged between 30 and 65 years
* living in the Departments of Mayenne, Vendée and Sarthe (Pays de la Loire, France)
* who have not carried out a screening test (cytology of smear or HPV test) following a letter sent 12 months previously (in 2020 or 2021).
Exclusion Criteria:
* recent cervical sampling (less than three years old)
* women younger than 30 or older than 65 years
* women who have had a hysterectomy
* women with ongoing follow-up for a cervical lesion
* women who are not members or beneficiaries of a social security system.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of participation in each arm (%)
Timeframe: 6 months
Trial details
NCT IDNCT05243888
SponsorCentre Regional de Coordination des Depistages des Cancer - Pays de la Loire