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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 30
Maximum Age: 64
Healthy Volunteers: t
View:

• women who have not been screened for cervical cancer since the last three years

• visiting their GP for whatever reason

Locations
Other Locations
Belgium
Université catholique de Louvain
RECRUITING
Brussels
Université de Liège
COMPLETED
Liège
Maison médicale Neptune
RECRUITING
Schaarbeek
Contact Information
Primary
Marc Arbyn, MD
marc.arbyn@sciensano.be
+32 2 642 50 21
Backup
Cindy Simoens, PhD
cindy.simoens@sciensano.be
+32 2 642 53 79
Time Frame
Start Date: 2021-04-19
Estimated Completion Date: 2024-06
Participants
Target number of participants: 1200
Treatments
Experimental: Intervention
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.
No_intervention: control
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.
Authors
Jean-Luc Belche
Related Therapeutic Areas
Sponsors
Collaborators: Horizon 2020 - European Commission
Leads: Sciensano

This content was sourced from clinicaltrials.gov