Offering Cervical Cancer Screening to Older Women

Study Overview
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Brief Summary
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This study evaluates the effect and feasibility of expanding the target population in the Danish cervical cancer screening program to include women aged 65 to 69 years. The study also evaluates if HPV self-sampling constitutes an appropriate screening method among older women.

Detailed Description
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The study is a nationwide population-based prospective cohort study embedded in the routine cervical cancer screening program in the Central Denmark Region. The study includes all 65 to 69 years old Danish women with no record of a cervical cytology sample or screening invitation within the last five years. Furthermore, the women are not registered as ineligible for screening, eg due hysterectomy. Eligible women residing in the Central Denmark Region are allocated to the intervention group (n=20,000), while women residing in the other four Danish regions are allocated to the control group receiving standard care (n=71,500), which for this group is low-level opportunistic screening at the general practitioner (GP). The intervention group are invited for HPV-based screening by the GP or to request a self-sampling kit.

Official Title
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Reducing the Burden of Cervical Cancer Among Older Women by Expanding the Screening Age and Offering HPV Self-sampling

Conditions
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Uterine Cervical Neoplasm, Uterine Neoplasm, Uterine Cervical Disease, Mass Screening

Intervention / Treatment
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* Other: GP-based screening or HPV self-sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 65 to 69 years; Resident in Denmark No record of a cervical cytology or screening invitation in the past 5 years Not registered as ineligible for screening Exclusion Criteria: Death Migration to or from Denmark Moving to or from the CDR Residing in the CDR, but having GP in another region A record of hysterectomy

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention group<br>Eligible women residing in the Central Denmark Region will be assigned to intervention group. Women in the intervention group receive an invitation for HPV-based cervical cancer screening by attending either 1) GP-based screening or 2) HPV self-sampling. The self-sampling kit includes the dry Evalyn brush self-sampling device (Rovers Medical Devices B.V, Oss, Netherlands), written and picture-based user instructions on how to collect and mail the self-sample, and a prestamped return envelope addressed to the Department of Pathology, Randers Regional Hospital. | Other: GP-based screening or HPV self-sampling<br>* Women in the intervention group will receive an invitation for HPV-based cervical cancer screening by either 1) scheduling an appointment for a cervical cytology by the GP or 2) collect a cervico-vaginal sample themselves in their own home using a self-sampling kit.<br>* Other names: Opportunistics GP-based screening;|
| Control group<br>Eligible women residing in the other five Danish regions (North, Central, South, Zealand and Capital ) will be assigned to control group. Women in the control group will receive usual care, which for 65-69 year-old women is opportunistic cervical cancer screening at the GP | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participation rate in the intervention group: | Participation rate, eg the roportion of targeted women participating by GP-based screening or self-sampling | 1 year post invitation | 
| HPV prevalence | Number of women tested positive for HPV | 1 year post invitation | 
| Compliance to follow-up among HPV-positive self-samplers | The proportion of HPV-positive self-samplers who attend appropriate follow-up by their GP for onward referral | 90 days post test results | 
| Screening history | Screening history of participants and non-participants in the intervention group | Average of 10 years | 
| Intervention versus control group: | Participation rate | 1 year post invitation | 
| Cytological findings | Proportion of abnormal cytological findings between the intervention and control group is compared | 1 year post invitation | 
| Histological findings | Proportion of abnormal histological findings between the intervention and control group is compared | 1 year post invitation | 
| Incidence | The incidence rate of cervical cancer developed within 5 year is compared between the intervention and control group | 5 year post invitation | 
| Mortality | The mortality rate of cervical cancer developed within 5 year is compared between the intervention and control group | 5 year post invitation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV self-sampling, cervical cancer screening in older women