Research Project on Reminders and Self-Sampling Can Increase Participation in Gynecology Cell Sampling - Preventive Examination Against Cervical Cancer.
NCT ID: NCT04061967
Last Updated: 2025-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20000 participants
INTERVENTIONAL
2019-08-19
2030-06-01
Brief Summary
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Invitations and reminders about cervical screening are sent by letter to the woman's home address (about 3 million letters per year in Sweden). This strategy results in a waste of resources and has a negative environmental impact. Regarding reminders, we have seen in previous research that the effect is not optimal. When sending a physical reminder letter to women who have not participated in more than 10 years (current routine), only 2% of the women invited came for sampling. Reminders with SMS are now standard for many businesses in society, such as car testing or dental appointments. It is inexpensive, saves the environment and there are studies that suggest it is more effective than sending physical letters. In this study, we intend to investigate whether SMS reminders, electronic letters, and physical letters for screening lead to increased participation and thus to a higher proportion of detected, treatable precursors of cervical cancer compared to before.
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Detailed Description
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The purpose of this study is to investigate whether SMS reminders and electronic letters for screening attendance will increase participation compared to the current method where reminders are sent out with physical letters. In this study, women a with high risk of developing cervical cancer, due to not fully participating in screening or being followed up optimally, will be invited. Women are identified through registry linkages annually that examine screening history and status using a risk algorithm. Women receive an SMS or an electronic letter with an offer to request a self-sampling kit via the internet. Women with a higher risk for cervical cancer can be offered a self-sampling kit sent directly to their home address. The self-sampling kit comes with an instruction on how to take the sample and a postage-free answer envelope.
Submitted samples are analyzed with an approved and accredited method (Cobas 4800, Roche) that analyzes for HPV 16, HPV18 and other oncogenic HPV types. As the screening program changed the accredited HPV test in 2022 (to BD Onclarity), that test will be used from the timepoint of the change and onwards.
In the pilot of the study, follow-up is defined as follows:
1. For those women who are at the highest risk (previous glandular cell changes without follow-up), all HPV-positive women are referred via SMS directly to a women's clinic for investigation. HPV-negative women in this group have no increased risk and receive a text message with a calming message.
2. Women of an age above the screening program but who have either had a cell change that is not followed up or who have not participated at all in the last 10 years are treated in the same way as in paragraph 1.
3. Finally, the women of screening age who have not taken a cell sample for more than 15 years are identified. This group receive an SMS and HPV-positive women are referred, via SMS, for renewed sampling by a specially trained so-called dysplasia midwife. The sample is now being analyzed for both cytology and HPV. If the woman is HPV positive in both tests and in the case of deviating cytology, the woman is referred to a women's clinic. In other cases a text message with a reassuring message is sent.
The study has the usual level of confidence (p \<0.05 two-sided) and statistical power (80%) the ability to demonstrate an increase of participation by 3 times or more.
The protocol was piloted in the Region of Skåne in 2019 and then rolled out nationally in 2020.
The study is rolled out nationally with annual linkages to identify women with an excess risk for cervical cancer and an adaptive approach to reaching women with SMS, electronic letters, and physically letters with direct delivery of HPV self-sampling kits or an option to order a self-sampling kid (depending on risk). The study is coordinated centrally and each region has a contact person to whom women who need follow-up are referred.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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HPV self sampling test ordered
An invitation to order a HPV self sampling test through an online application will be sent by SMS or electronic letter.
Sending of screening summon.
2019-2021 - A Cobas PCR Female swab sample packet will be sent. Response rates (participation) will be measured.
2022 and onwards - A FLOQSwab and corresponding sample tube for analysis on the BD COR platform will be sent.
Interventions
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Sending of screening summon.
2019-2021 - A Cobas PCR Female swab sample packet will be sent. Response rates (participation) will be measured.
2022 and onwards - A FLOQSwab and corresponding sample tube for analysis on the BD COR platform will be sent.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
33 Years
75 Years
FEMALE
No
Sponsors
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Region Skane
OTHER
Karolinska Institutet
OTHER
Responsible Party
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Miriam Elfström
Affiliated Researcher
Principal Investigators
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Miriam Elfström, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Northern Region
Luleå, Norrbotten County, Sweden
Southern Region
Lund, Skåne County, Sweden
Western Region
Gothenburg, Västra Götaland County, Sweden
Southeast Region
Jönköping, , Sweden
Region of Stockholm-Gotland
Stockholm, , Sweden
Region of Middle Sweden
Uppsala, , Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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Elfstrom KM, Sundstrom K, Andersson S, Bzhalava Z, Carlsten Thor A, Gzoul Z, Ohman D, Lamin H, Eklund C, Dillner J, Tornberg S. Increasing participation in cervical screening by targeting long-term nonattenders: Randomized health services study. Int J Cancer. 2019 Dec 1;145(11):3033-3039. doi: 10.1002/ijc.32374. Epub 2019 May 10.
Arroyo Muhr LS, Wang J, Hassan SS, Yilmaz E, Elfstrom MK, Dillner J. Nationwide registry-based trial of risk-stratified cervical screening. Int J Cancer. 2025 Jan 15;156(2):379-388. doi: 10.1002/ijc.35142. Epub 2024 Aug 15.
Wang J, Elfstrom KM, Borgfeldt C, Dillner J. A pilot study of risk-stratified cervical cancer screening. Open Res Eur. 2022 Sep 1;1:84. doi: 10.12688/openreseurope.13398.2. eCollection 2021.
Other Identifiers
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2019-03166
Identifier Type: -
Identifier Source: org_study_id
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