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

NCT05243888 | Active Not Recruiting

• 1 other identifier: 2021-A01660-41
• Study Type: interventional
• Target: 15,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Screening Test

Keywords

cervical cancer; screening coverage; cancer screening test; under-screened women; urinary self-sampling; vaginal self-sampling; randomised controlled trial; semi-structured interviews

Outcome Measures

Primary Outcomes (1)

• Rate of participation in each arm (%)

  (number of responding / number of invited)

  6 months

Secondary Outcomes (14)

• Rate of participation (%)

  6 months

• Rate of participation (%) with questionnaire or not

  6 months

• Rate of screen test positivity (%)

  24 months

• Percentage of women screened positive with adherence to gynecological follow-up

  24 months

• Impact of age on the participation (rate of participation %)

  6 months

Study Arms (3)

control

NO INTERVENTION

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.

vaginal self-sampling

EXPERIMENTAL

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

Diagnostic Test: self-sampling

urinary self-sampling

EXPERIMENTAL

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

Diagnostic Test: self-sampling

Interventions

self-sampling DIAGNOSTIC_TEST

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

urinary self-sampling; vaginal self-sampling

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Regional de Coordination des Depistages des Cancer - Pays de la Loire: lead
• National Cancer Institute, France: collaborator
• Sciensano: collaborator
• University Hospital, Angers: collaborator
• University of Angers: collaborator

Study Sites (1)

CRCDC Pays de la Loire

Angers, France

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 17, 2022
• Study Start: March 9, 2022
• Primary Completion: August 31, 2023
• Study Completion: March 1, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-02

Locations

FR (1)