Efficacy of Offering a Self-sampling Device by the GP to Reach Underscreened Women

Not Applicable

Recruiting

• Conditions: Cervical Cancer
• Interventions: Other: Provision of self sampling device by the GP; Other: Provision of self sampling device by letter

• Registration Number: NCT05656976
• Lead Sponsor: University Ghent

Brief Summary

The ESSAG trial invests the impact of offering a free self-sampling device (SSD) on the cervical cancer screening rate of underscreened women. This study is aimed at women between the age of 31 and 65 who did not have a smear taken during the last 6 years. In order to assess the effect of a) providing the SSD, and b) the intervention of the general practitioner (GP) (either face-to-face, either by sending the SSD by letter), a randomized control trial is set up with three arms. The ESSAG trial evolves from a collaboration between Universiteit Gent and Vrije Universiteit Brussel, Katholieke Universiteit Leuven, Universiteit Antwerpen, Sciensano, het Centrum voor Kankeropsporing en het Belgisch Kankerregister, and is funded by "Kom Op Tegen Kanker".

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-23
• Study First Submitted QC: 2022-12-07
• Study First Posted: 2022-12-20
• Status Verified: 2023-09
• Study Start: 2023-09-01
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-04
• Primary Completion: 2024-08-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 3375

Inclusion Criteria

• women between 31-64 years old
• living in Flanders
• eligible for the Flemish actions with regard to population screening
• without a smear registered in the Belgian Cancer Registry in the last 6 years
• registered as GMD patient in one of the participating GP practices

Exclusion Criteria

• hysterectomy
• pregnancy
• (past) diagnosis of cervical cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A Self sampling device (SSD) provided by the general practitioner (GP)	Provision of self sampling device by the GP	A self sampling device will be provided by the GP.
B Self sampling device provided by letter	Provision of self sampling device by letter	A self sampling device will be provided by letter.

Primary Outcome Measures

Name	Time	Method
Response rate	Up to 6 months	Age-standardised response rates in each arm and the differences between arms will be calculated, in a per protocol (PP) and intention-to-treat (ITT) analysis.; As the goal is to reveal to what extent the respective approach (providing a self sampling device (SSD) with different levels of general practitioner (GP) involvement) succeeds in reaching vulnerable women, analyses will take into account a comprehensive list of covariates by logistic regression accounting for cluster effects. These covariates include trial arm, GP-office characteristics, as well as demographic information of the patient on origin and socio-economical background provided by the "Kruispuntbank voor Sociale Zekerheid (KSZ)".

Secondary Outcome Measures

Name	Time	Method
Response rate (follow-up cytology test)	Up to 3 months	Although this study is not powered for inter-arm differences in follow-up after an abnormal screening test result, compliance analysis will be performed with the following indicators: screen-test positivity rates, proportion with invalid screen-test results, proportion of screen-test positives that have the foreseen follow-up tests.
Participation rate	Up to 9 months	The participation rate will be calculated from arm A to answer questions at public health level, i.e. the population effect of the intervention by GP's on increasing cervical cancer screening coverage in underscreened women.; For participation rate, the denominator are all women who belong to the target group for that specific GP-office (women between 31-64y, not screened within 6y, etc).
Cost-effectiveness analysis	Up to 15 months	A cost-effectiveness analysis will also be performed, addressing the additional number of women screened per 1,000€ in interventions A and B versus control intervention C.
Feasibility analysis (semi-structured interviews with GP's)	Up to 4 months after the intervention in their practice	In order to explore the potential roll-out of the study within the Flemish screening programme, the investigators will also perform a feasibility study. Through interviews with 20-30 GPs who participated in arm A, a feasibility analysis will reveal the strengths and pitfalls of the intervention.

Trial Locations

Locations (1)

Ghent University; 🇧🇪 Ghent, Belgium