NCT05656976

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 64 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 cluster 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".

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,375

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Sep 2023Jul 2026

First Submitted

Initial submission to the registry

November 23, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 20, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Expected
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

November 23, 2022

Last Update Submit

February 11, 2026

Conditions

Cervical Cancer

Keywords

PreventionScreening

Outcome Measures

Primary Outcomes (1)

  • Response rate

    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)".

    Up to 6 months

Secondary Outcomes (4)

  • Participation rate

    Up to 6 months

  • Cost-effectiveness analysis

    Up to 15 months

  • Feasibility analysis (semi-structured interviews with GP's)

    Up to 4 months after the intervention in their practice

  • Response rate (follow-up cytology test)

    Up to 3 months

Study Arms (3)

A Self sampling device (SSD) provided by the general practitioner (GP)

EXPERIMENTAL

A self sampling device will be provided by the GP.

Other: Provision of self sampling device by the GP

B Self sampling device provided by letter

EXPERIMENTAL

A self sampling device will be provided by letter.

Other: Provision of self sampling device by letter

C (control arm) Recommendation letter

NO INTERVENTION

Following the usual care procedure, a random sample of 1125 Flemish women who meet the same inclusion criteria as in arm A and B and are not included in one of the latter arms is drawn by "Centrum voor Kankeropsporing" (CvKO) from Heracles, the database of the Flemish screening program.

Interventions

Provision of self sampling device by letterOTHER

In the second arm, a second group of 45 GP practices in Flanders will be recruited. With the intervention of the Centre for Cancer Prevention (Flanders), 25 at randomly selected long-term unscreened women with a Global Medical Form (in dutch: 'Globaal Medisch Dossier, GMD) in one of these practices will receive an envelope containing a letter of invitation from their GP for cervical cancer screening, a brochure with the advantages and disadvantages of cervical cancer screening and more specifically the use of a self-taking kit, and a self-taking kit. If the woman wishes, she can use the kit when and where it suits her and send it to the lab with the pre-paid envelope. As in arm A, the woman will be informed of the Human Papilloma Virus test result by her GP according to the usual way in the practice (e.g., by letter, by phone or during the next consultation). All women will receive a study-related reminder letter after 4 months.

B Self sampling device provided by letter
Provision of self sampling device by the GPOTHER

In a group of 45 GP practices, over a course of 6 months, all long-term unscreened women with a GMD will be addressed by their GP when they consult for any reason. The GP will discuss the pros and cons of screening for cervical cancer, the various options for screening for cervical cancer including the possibility of using a SSD. For this, the GP can use on accessible brochure and video materials. After the woman agrees, she is given a self-taking kit that she can use when and where it suits her and send it to the lab with the prepaid envelope. The woman is informed of the result of the Human Papillomavirus test result by her GP according to the usual way in the practice (e.g. via letter, by phone or during the next consultation).

A Self sampling device (SSD) provided by the general practitioner (GP)

Eligibility Criteria

Age31 Years - 64 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, 9000, Belgium

Location

Related Publications (1)

  • Gezels E, Van Roy K, Arbyn M, Coursier P, Devroey D, Martens P, Simoens C, Vaes B, Van Herck K, Vankrunkelsven P, Verhoeven V, Willems S. The ESSAG-trial protocol: A randomized controlled trial evaluating the efficacy of offering a self-sampling kit by the GP to reach women underscreened in the routine cervical cancer screening program. Contemp Clin Trials. 2024 Sep;144:107617. doi: 10.1016/j.cct.2024.107617. Epub 2024 Jul 6.

    PMID: 38977179DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Kaatje Van Roy

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial (RCT)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2022

First Posted

December 20, 2022

Study Start

September 1, 2023

Primary Completion

August 31, 2024

Study Completion (Estimated)

July 31, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02

Locations

BE(1)