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

University Ghent

Status: Enrolling

Conditions: Cervical Cancer

Treatments: Other: Provision of self sampling device by the GP; Other: Provision of self sampling device by letter

Study type: Interventional

Funder types: Other

Identifiers

NCT05656976

ONZ-2022-0250

Details and patient eligibility

About

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".

Enrollment: 3,375 estimated patients

Sex: Female

Ages: 31 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,375 participants in 3 patient groups

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

Experimental group

Description:

A self sampling device will be provided by the GP.

Treatment:

Other: Provision of self sampling device by the GP

B Self sampling device provided by letter

Experimental group

Description:

A self sampling device will be provided by letter.

Treatment:

Other: Provision of self sampling device by letter

C (control arm) Recommendation letter

No Intervention group

Description:

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.