Offering Cervical Cancer Screening to Older Women
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Intervention group 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
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.
Other Names:
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| Control group 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 |
Outcome Measures
Primary Outcome Measures
- Participation rate in the intervention group: [1 year post invitation]
Participation rate, eg the roportion of targeted women participating by GP-based screening or self-sampling
- HPV prevalence [1 year post invitation]
Number of women tested positive for HPV
- Compliance to follow-up among HPV-positive self-samplers [90 days post test results]
The proportion of HPV-positive self-samplers who attend appropriate follow-up by their GP for onward referral
- Screening history [Average of 10 years]
Screening history of participants and non-participants in the intervention group
- Intervention versus control group: [1 year post invitation]
Participation rate
- Cytological findings [1 year post invitation]
Proportion of abnormal cytological findings between the intervention and control group is compared
- Histological findings [1 year post invitation]
Proportion of abnormal histological findings between the intervention and control group is compared
- Incidence [5 year post invitation]
The incidence rate of cervical cancer developed within 5 year is compared between the intervention and control group
- Mortality [5 year post invitation]
The mortality rate of cervical cancer developed within 5 year is compared between the intervention and control group
Eligibility Criteria
Criteria
Inclusion Criteria:
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65 to 69 years;
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Resident in Denmark
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No record of a cervical cytology or screening invitation in the past 5 years
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Not registered as ineligible for screening
Exclusion Criteria:
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Death
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Migration to or from Denmark
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Moving to or from the CDR
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Residing in the CDR, but having GP in another region
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A record of hysterectomy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mette Tranberg Nielsen | Randers | Randers NØ | Denmark | 8930 |
Sponsors and Collaborators
- University of Aarhus
Investigators
- Principal Investigator: Mette T Tranberg, post doc phd, Randers Regional Hospital, Central Denmark Region
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2702