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NCT Number: NCT05656976

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

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".

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

31 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Provision of self sampling device by the GP

Other

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).

Provision of self sampling device by letter

Other

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.

Primary outcomes

  1. Response rate

    Time frame: 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 outcomes

  1. Participation rate

    Time frame: Up to 6 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).

  2. Cost-effectiveness analysis

    Time frame: 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.

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

    Time frame: 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.

  4. Response rate (follow-up cytology test)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • Belgian Cancer Registry
  • Centrum voor Kankeropsporing
  • KU Leuven
  • Kom Op Tegen Kanker
  • Sciensano
  • Universiteit Antwerpen
  • Vrije Universiteit Brussel

Registry information

Official study title

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

Acronym: ESSAG

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Dec 20, 2022
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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