Clinical trial · Interventional
Efficacy of Offering a Self-sampling Device by the GP to Reach Underscreened Women
Efficacy of Offering a Self-sampling Device by the General Practitioner to Reach Women Underscreened in the Routine Cervical Cancer Screening Program Compared to Sending Reminder Letters by the Screening Organization
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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".
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Provision of self sampling device by letter | Other | — | UNRESOLVED |
| Provision of self sampling device by the GP | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- A Self sampling device (SSD) provided by the general practitioner (GP)
- description
- A self sampling device will be provided by the GP.
- interventionNames
- Other: Provision of self sampling device by the GP
- type
- EXPERIMENTAL
- label
- B Self sampling device provided by letter
- description
- A self sampling device will be provided by letter.
- interventionNames
- Other: Provision of self sampling device by letter
- type
- NO_INTERVENTION
- label
- C (control arm) Recommendation letter
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 31 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGezels 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 38977179