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

Eva Gezels; Kaatje Van Roy; Marc Arbyn; Patrick Coursier; Dirk Devroey; Patrick Martens; Cindy Simoens; Bert Vaes; Koen Van Herck; Patrick Vankrunkelsven; Veronique Verhoeven; Sara Willems

doi:10.1016/j.cct.2024.107617

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

Eva Gezels, Kaatje Van Roy, Marc Arbyn, Patrick Coursier, Dirk Devroey, Patrick Martens, Cindy Simoens, Bert Vaes, Koen Van Herck, Patrick Vankrunkelsven, Veronique Verhoeven, Sara Willems

Research output: Contribution to journal › Article › peer-review

Abstract

BACKGROUND: In Flanders (Belgium), women not screened for cervical cancer (CC) within the last three years receive an invitation letter from the regional screening organization, the Centre for Cancer Detection (CCD), encouraging them to have a cervical specimen taken by their general practitioner (GP) or gynecologist. However, the coverage for CC screening remains suboptimal (63%). The offer of a self-sampling kit (SSK, for HPV testing) by a GP may trigger participation among women who do not attend regular screening.

METHODS: The ESSAG-trial is a cluster-randomized controlled trial with three arms, each including 1125 women aged 31-64 years, who were not screened for CC in the last 6 years. In arm A, GPs offer a SSK when eligible women consult for any reason. In arm B, women receive a personal GP signed invitation letter including an SSK at their home address. In the control arm, women receive the standard invitation letter from the CCD. The primary outcome is the response rate at three months after inclusion. Secondary outcomes are: screen test positivity; compliance with foreseen follow-up among screen-positives; costs per invited and per screened women; as well as contrasts between trial arms and between socio-demographic categories.

CONCLUSION: The ESSAG-trial will assess the effect of GP-based interventions using SSKs on CC screening participation among hard-to-reach populations. Findings will inform policymakers about feasible strategies on increasing CC screening that may be rolled-out throughout the whole region.

TRIAL REGISTRATION: ClinicalTrials.gov: NCT05656976.

Original language	English
Article number	107617
Number of pages	7
Journal	Contemporary Clinical Trials
Volume	144
Early online date	6 Jul 2024
DOIs	https://doi.org/10.1016/j.cct.2024.107617
Publication status	Published - Sep 2024

Bibliographical note

Copyright © 2024. Published by Elsevier Inc.

Funding Information:
The ESSAG trial is funded by Kom op tegen Kanker (Stand up to Cancer) , the Flemish cancer society (project ID: 12343 ). The funder has no involvement in any part of the project.

Funding Information:
The Flemish cervical cancer screening program is funded by the Flemish government .

Funding Information:
The ESSAG trial is funded by Kom op tegen Kanker (Stand up to Cancer), the Flemish cancer society (project ID: 12343). The funder has no involvement in any part of the project.MA and CS are supported by the Horizon 2020 Framework Program for Research and Innovation of the European Commission, through the RISCC Network (Grant No. 847845).The authors thank the GPs who are willing to participate in the trial. The Flemish cervical cancer screening program is funded by the Flemish government.

Publisher Copyright:
© 2024 Elsevier Inc.

Keywords

Cervical cancer screening
General practitioner
Primary care
Self-sampling kit
Study protocol
cervicovaginal self-sampling device
adult
article
atypical squamous cells of the cervix
cancer registry
cancer screening
clinical effectiveness
clinical trial protocol
controlled study
cost effectiveness analysis
female
follow up
general practitioner
health care cost
human
major clinical study
randomized controlled trial
residence characteristics
uterine cervix cancer

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10.1016/j.cct.2024.107617

Cite this

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. (2024). 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. Contemporary Clinical Trials, 144, [107617]. https://doi.org/10.1016/j.cct.2024.107617

Gezels, Eva ; Van Roy, Kaatje ; Arbyn, Marc ; Coursier, Patrick ; Devroey, Dirk ; Martens, Patrick ; Simoens, Cindy ; Vaes, Bert ; Van Herck, Koen ; Vankrunkelsven, Patrick ; Verhoeven, Veronique ; Willems, Sara. / 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. In: Contemporary Clinical Trials. 2024 ; Vol. 144.

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title = "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",

abstract = "BACKGROUND: In Flanders (Belgium), women not screened for cervical cancer (CC) within the last three years receive an invitation letter from the regional screening organization, the Centre for Cancer Detection (CCD), encouraging them to have a cervical specimen taken by their general practitioner (GP) or gynecologist. However, the coverage for CC screening remains suboptimal (63%). The offer of a self-sampling kit (SSK, for HPV testing) by a GP may trigger participation among women who do not attend regular screening.METHODS: The ESSAG-trial is a cluster-randomized controlled trial with three arms, each including 1125 women aged 31-64 years, who were not screened for CC in the last 6 years. In arm A, GPs offer a SSK when eligible women consult for any reason. In arm B, women receive a personal GP signed invitation letter including an SSK at their home address. In the control arm, women receive the standard invitation letter from the CCD. The primary outcome is the response rate at three months after inclusion. Secondary outcomes are: screen test positivity; compliance with foreseen follow-up among screen-positives; costs per invited and per screened women; as well as contrasts between trial arms and between socio-demographic categories.CONCLUSION: The ESSAG-trial will assess the effect of GP-based interventions using SSKs on CC screening participation among hard-to-reach populations. Findings will inform policymakers about feasible strategies on increasing CC screening that may be rolled-out throughout the whole region.TRIAL REGISTRATION: ClinicalTrials.gov: NCT05656976.",

keywords = "Cervical cancer screening, General practitioner, Primary care, Self-sampling kit, Study protocol, cervicovaginal self-sampling device, adult, article, atypical squamous cells of the cervix, cancer registry, cancer screening, clinical effectiveness, clinical trial protocol, controlled study, cost effectiveness analysis, female, follow up, general practitioner, health care cost, human, major clinical study, randomized controlled trial, residence characteristics, uterine cervix cancer",

author = "Eva Gezels and {Van Roy}, Kaatje and Marc Arbyn and Patrick Coursier and Dirk Devroey and Patrick Martens and Cindy Simoens and Bert Vaes and {Van Herck}, Koen and Patrick Vankrunkelsven and Veronique Verhoeven and Sara Willems",

note = "Copyright {\textcopyright} 2024. Published by Elsevier Inc. Funding Information: The ESSAG trial is funded by Kom op tegen Kanker (Stand up to Cancer) , the Flemish cancer society (project ID: 12343 ). The funder has no involvement in any part of the project. Funding Information: The Flemish cervical cancer screening program is funded by the Flemish government . Funding Information: The ESSAG trial is funded by Kom op tegen Kanker (Stand up to Cancer), the Flemish cancer society (project ID: 12343). The funder has no involvement in any part of the project.MA and CS are supported by the Horizon 2020 Framework Program for Research and Innovation of the European Commission, through the RISCC Network (Grant No. 847845).The authors thank the GPs who are willing to participate in the trial. The Flemish cervical cancer screening program is funded by the Flemish government. Publisher Copyright: {\textcopyright} 2024 Elsevier Inc.",

year = "2024",

month = sep,

doi = "10.1016/j.cct.2024.107617",

language = "English",

volume = "144",

journal = "Contemporary clinical trials",

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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 2024, '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', Contemporary Clinical Trials, vol. 144, 107617. https://doi.org/10.1016/j.cct.2024.107617

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. / Gezels, Eva; Van Roy, Kaatje; Arbyn, Marc; Coursier, Patrick; Devroey, Dirk; Martens, Patrick; Simoens, Cindy; Vaes, Bert; Van Herck, Koen; Vankrunkelsven, Patrick; Verhoeven, Veronique; Willems, Sara.

In: Contemporary Clinical Trials, Vol. 144, 107617, 09.2024.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - The ESSAG-trial protocol

T2 - 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

AU - Gezels, Eva

AU - Van Roy, Kaatje

AU - Arbyn, Marc

AU - Coursier, Patrick

AU - Devroey, Dirk

AU - Martens, Patrick

AU - Simoens, Cindy

AU - Vaes, Bert

AU - Van Herck, Koen

AU - Vankrunkelsven, Patrick

AU - Verhoeven, Veronique

AU - Willems, Sara

N1 - Copyright © 2024. Published by Elsevier Inc. Funding Information: The ESSAG trial is funded by Kom op tegen Kanker (Stand up to Cancer) , the Flemish cancer society (project ID: 12343 ). The funder has no involvement in any part of the project. Funding Information: The Flemish cervical cancer screening program is funded by the Flemish government . Funding Information: The ESSAG trial is funded by Kom op tegen Kanker (Stand up to Cancer), the Flemish cancer society (project ID: 12343). The funder has no involvement in any part of the project.MA and CS are supported by the Horizon 2020 Framework Program for Research and Innovation of the European Commission, through the RISCC Network (Grant No. 847845).The authors thank the GPs who are willing to participate in the trial. The Flemish cervical cancer screening program is funded by the Flemish government. Publisher Copyright: © 2024 Elsevier Inc.

PY - 2024/9

Y1 - 2024/9

N2 - BACKGROUND: In Flanders (Belgium), women not screened for cervical cancer (CC) within the last three years receive an invitation letter from the regional screening organization, the Centre for Cancer Detection (CCD), encouraging them to have a cervical specimen taken by their general practitioner (GP) or gynecologist. However, the coverage for CC screening remains suboptimal (63%). The offer of a self-sampling kit (SSK, for HPV testing) by a GP may trigger participation among women who do not attend regular screening.METHODS: The ESSAG-trial is a cluster-randomized controlled trial with three arms, each including 1125 women aged 31-64 years, who were not screened for CC in the last 6 years. In arm A, GPs offer a SSK when eligible women consult for any reason. In arm B, women receive a personal GP signed invitation letter including an SSK at their home address. In the control arm, women receive the standard invitation letter from the CCD. The primary outcome is the response rate at three months after inclusion. Secondary outcomes are: screen test positivity; compliance with foreseen follow-up among screen-positives; costs per invited and per screened women; as well as contrasts between trial arms and between socio-demographic categories.CONCLUSION: The ESSAG-trial will assess the effect of GP-based interventions using SSKs on CC screening participation among hard-to-reach populations. Findings will inform policymakers about feasible strategies on increasing CC screening that may be rolled-out throughout the whole region.TRIAL REGISTRATION: ClinicalTrials.gov: NCT05656976.

AB - BACKGROUND: In Flanders (Belgium), women not screened for cervical cancer (CC) within the last three years receive an invitation letter from the regional screening organization, the Centre for Cancer Detection (CCD), encouraging them to have a cervical specimen taken by their general practitioner (GP) or gynecologist. However, the coverage for CC screening remains suboptimal (63%). The offer of a self-sampling kit (SSK, for HPV testing) by a GP may trigger participation among women who do not attend regular screening.METHODS: The ESSAG-trial is a cluster-randomized controlled trial with three arms, each including 1125 women aged 31-64 years, who were not screened for CC in the last 6 years. In arm A, GPs offer a SSK when eligible women consult for any reason. In arm B, women receive a personal GP signed invitation letter including an SSK at their home address. In the control arm, women receive the standard invitation letter from the CCD. The primary outcome is the response rate at three months after inclusion. Secondary outcomes are: screen test positivity; compliance with foreseen follow-up among screen-positives; costs per invited and per screened women; as well as contrasts between trial arms and between socio-demographic categories.CONCLUSION: The ESSAG-trial will assess the effect of GP-based interventions using SSKs on CC screening participation among hard-to-reach populations. Findings will inform policymakers about feasible strategies on increasing CC screening that may be rolled-out throughout the whole region.TRIAL REGISTRATION: ClinicalTrials.gov: NCT05656976.

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KW - General practitioner

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KW - atypical squamous cells of the cervix

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KW - cancer screening

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KW - cost effectiveness analysis

KW - female

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KW - randomized controlled trial

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SN - 1551-7144

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ER -

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

Abstract

Bibliographical note

Keywords

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