Increase in Response by Offering Self-sampling Devices in Belgian GP Practices to Non-screened Women

NCT04903561 | Unknown

• 1 other identifier: Sciensano_2021_001
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 3

Brief Summary

Small scale data indicate that cervical cancer screening participation may increase when self-sampling (SS) devices are offered directly by health care workers to non-screened woman, when those woman contact health services for whatever reason. The purpose of the current research is to reproduce the early findings of a MSc project conducted in a general practitioners (GP) group practice in Brussels, where women not screened since \>3 years randomized to direct reception of a SS kit yielded a response of 78% vs 51% in the control arm. BELGSSAR will also investigate whether GP's have the information on the most important risk factors for cervical cancer available in their patient files.

Conditions

Cervical Cancer

Keywords

cervical cancer screening; self sampling kit; general practicioners; ColliPee; Evalyn Brush

Outcome Measures

Primary Outcomes (1)

• Difference in response between intervention and control arm (per protocol (PP) and intention to treat analyses [ITT]).

  Difference in response in women included in the self-sampling arms vs the control arm (per protocol (PP) and intention to treat analyses \[ITT\]). The absolute difference in response rate = proportion with screening test in experimental arm - proportion with screening test in control arm, within 6 months after enrolment. In the PP analysis only women with a screening test on the self-sample according to the specific experimental intervention will be taken into account, whereas in the ITT analysis all screening tests performed within 6 months after enrolment will be considered (also those performed on samples taken by a clinician).

  2 years and 4 months

Secondary Outcomes (7)

• Absolute response rates in each arm and each GP practice

  2 years and 7 months

• Heterogeneity in response rate differences, over the eight GP practices (assessed by the Cochran Q test for heterogeneity)

  2 years and 7 months

• net difference in response rate between practices offering vaginal self-sampling devices vs offering urine collection devices • Difference in response between practices offering self-sampling collection at the GP's office vs at home.

  2 years and 7 months

• net difference in response rate between practices offering self-sampling collection at the GP's office vs at home.

  2 years and 7 months

• Screen test positivity rate (by arm [PP and ITT], GP intervention)

  2 years and 7 months

Study Arms (2)

Intervention

EXPERIMENTAL

In the experimental arms, the woman will be asked to collect a vaginal sample with the Evalyn® Brush or a urine sample with the Colli-PeeTM. Women shall receive this self-sampling device directly from the GP or shall pick it up at a close by pharmacist with a prescription of the GP. In four GP practices (1, 2, 5, 6) the patient has to collect the SS preferentially in the GP practice (at home if the GP practice is not well equipped) whereas in the other four GP practices (3, 4, 7, 8), the patient has to collect the SS at home and send it to the laboratory by using a prepaid envelope.

Device: ColliPee

control

NO INTERVENTION

Women in the control group will receive an oral recommendation given by the GP with a reminder of the current screening policy to have a cervical sample taken by a physician chosen by the woman. This clinician-taken cervical sample will be sent to a laboratory for processing with the usual screening test. Today the usual screening test still is cytology, but this will change in the future (date to be defined) to an HPV test.

Interventions

ColliPee DEVICE

The GP will hand over the self-sampling kit to the women, after obtaining informed consent, and the women then takes the self sample at home or in the doctor's office (predefined), according to the respective users manual.

Also known as: Evalyn Brush

Intervention

Eligibility Criteria

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

You may qualify if:

• women who have not been screened for cervical cancer since the last three years
• visiting their GP for whatever reason

You may not qualify if:

• pregnant women,
• women under active follow-up because of previous cervical abnormality,
• women who had a total hysterectomy,
• women who had a history of cervical cancer or a treatment for cervical precancer less than three years ago,
• non-consenting women,
• women who are not able to understand and sign the informed consent

Sponsors & Collaborators

• Sciensano: lead
• Horizon 2020 - European Commission: collaborator

Study Sites (3)

Université catholique de Louvain

Brussels, 1080, Belgium

RECRUITING

Université de Liège

Liège, 4000, Belgium

COMPLETED

Maison médicale Neptune

Schaarbeek, 1030, Belgium

RECRUITING

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

Central Study Contacts

Marc Arbyn, MD

CONTACT

+32 2 642 50 21; marc.arbyn@sciensano.be

Cindy Simoens, PhD

CONTACT

+32 2 642 53 79; cindy.simoens@sciensano.be

Study Design

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

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 26, 2021
• Study Start: April 19, 2021
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: November 24, 2023

Record last verified: 2023-11

Locations

BE (3)