Efficacy of Strategies Involving Self-sampling to Reach Women Not Participating in Regular Cervical Cancer Screening

NCT ID: NCT05243888

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-09
• Study Completion Date: 2025-03-31

Brief 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.

Detailed Description

Research question: does the offer of self-sampling kits result in higher attendance to cervical cancer screening compared to sending invitation letters which recommend women to contact a health professional for taking a cervical specimen?

Systematic reviews indicate that Human Papillomavirus (HPV) testing on vaginal specimens taken by the woman her-self is as accurate to detect cervical precancer as HPV testing of cervical specimens collected by a clinician, under the condition that a validated polymerase chain reaction (PCR)-based HPV assay is used. Similar results are shown from recent studies where HPV testing was performed on first-void urine collected with an appropriate device and transport medium. A recent meta-analysis of randomised trials showed higher response rates when under-screened women receive a self-sampling kit at home compared to traditional invitation or reminder letters. However, the absolute participation rates are highly variable among studies. Whereas qualitative research indicates that women prefer collection of urine rather than a vaginal self-sample, no data are available that the offer of urine kits would result in higher participation among women who do not participate regularly in cervical cancer screening.

Objectives:

• To evaluate the effectiveness of two experimental invitation strategies (urine or vaginal self-sampling) to reach under-screened populations and compare them to the current invitation strategy in rural departments in France.
• To improve the response rate among women aged 30 to 65 years (not screened over a period longer than the recommended screening interval) who did not respond to a conventional prior invitation.

Trial design:

1:1:1 randomised population-based participation trial, with 2 experimental and 1 control arm, with in each arm a 1:1 sub-randomisation with subgroup A receiving a questionnaire and subgroup B receiving no questionnaire.

Conditions

Cancer Screening Test

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

control

The control arm corresponds to women receive a conventional invitation letter sent by post to the home address of eligible women recommending them to make an appointment to a doctor or a midwife for the collection of a cervical specimen.

Group Type: NO_INTERVENTION

No interventions assigned to this group

vaginal self-sampling

eligible women receive at their home address a vaginal self-sampling kit in addition to the conventional invitation letter

Group Type: EXPERIMENTAL

self-sampling

Intervention Type: DIAGNOSTIC_TEST

eligible women receive at their home address a self-sampling kit in addition to the conventional invitation letter

urinary self-sampling

eligible women receive at their home address a urine collection kit in addition to the conventional invitation letter

Group Type: EXPERIMENTAL

self-sampling

Intervention Type: DIAGNOSTIC_TEST

eligible women receive at their home address a self-sampling kit in addition to the conventional invitation letter

Interventions

self-sampling

eligible women receive at their home address a self-sampling kit in addition to the conventional invitation letter

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute, France

OTHER_GOV

Sponsor Role: collaborator

Sciensano

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Angers

OTHER_GOV

Sponsor Role: collaborator

University of Angers

UNKNOWN

Sponsor Role: collaborator

Centre Regional de Coordination des Depistages des Cancer - Pays de la Loire

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CRCDC Pays de la Loire

Angers, , France

Countries

France

Other Identifiers

2021-A01660-41

Identifier Type: -

Identifier Source: org_study_id