SMS-based Summons in Cervical Screening

Study Overview
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Brief Summary
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Prevention of cervical cancer with cervical screening (gynecological cell test) is one of the most successful screening activities in medicine. In Sweden screening has taken place since the 1960s and prevented tens of thousands of women from having cervical cancer. There are strong reasons why it is especially important to promote that invitations to sampling really is reaching out. The women who regularly attend screening after the invitation reduce their risk of cervical cancer by as much as 90%. Of the women who currently have cervical cancer (about 550 women per year in Sweden), as many as 38% did not participate in the screening. Invitations for screening are sent to the entire population in Sweden aged 23-70. Current national estimate of how many in the population participating as recommended is 82.9% of the population. In addition, many women sometimes participate (they then get some reduced cancer risk). The highest cancer risk is among those women who have never participated as well as women who have had cell changes but have not participated. Cervical cancer is the first form of cancer for which there are approved molecular screening tests (HPV test). Unlike the older screening method (cytology), it works great to take a cervical sample at home if the sample is to be analyzed for HPV (the analysis method is so sensitive that it does not matter if the sample is not optimally taken). Invitations and reminders about cervical screening are today sent out with physical letters (about 3 million letters per year in Sweden). These dispatches involve 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 recalled 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 for screening lead to increased participation and thus to a higher proportion of detected, treatable precursors of cervical cancer compared to before.

Detailed Description
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Non-participation in the cervical screening program is the main risk factor for cervical cancer. Therefore it is important to reduce barriers to screening and facilitate participation in the screening program of cervical cancer. Offering self-sampling kits for human papillomavirus (HPV) testing has been examined in several research studies as a way to reach women who have not responded to screening invitations. The purpose of this study is to investigate whether SMS reminders for screening attendance will increase participation compared to the current method where reminders are sent out with physical letters. In this study, approximately 20,000 women with high risk of developing cervical cancer, due to not fully participating in screening, will be invited. The women receive an SMS offer to request a self-sampling kit via the internet. 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 carcinogens HPV types. 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. 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. 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 will be piloted in the Region of Skåne in 2019 and then rolled out nationally in 2020.

Official Title
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Can SMS-reminders Result in Increased Participation in Cervical Screening?

Conditions
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Cervical Cancer, Uterine Cervical Neoplasm, Uterine Neoplasms, Genital Neoplasm, Genital Neoplasm, Female, Uterine Diseases, Genital Diseases, Female, Neoplasms by Site, Neoplasms, Uterine Cervical Disease

Intervention / Treatment
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* Other: Sending of screening summon.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women resident in Region Skane who either: 1) have had glandular cell transformation that has not been followed-up, 2) are older than 65 years and have had cell transformation that has not been followed-up or who have not participated in screening during the last 10 years, 3) women who have not been screened for more than 15 years. Exclusion Criteria: No exclusion except those who do not consent.

Ages Eligible for Study
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Minimum Age: 33 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HPV self sampling test ordered<br>An invitation to order a HPV self sampling test through an online application will be sent by SMS | Other: Sending of screening summon.<br>* A Cobas PCR Female swab sample packet will be sent. Response rates will be measured.<br>* Other names: Response to screening summon.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of women responding to summon | Participation rate in screening after summons. | Measured from the date of the summons until 12 months after the summons | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of positive screens | Screening test results | Measured from the date of the summons until 12 months after the summons | 
| Rate of precursors of cancer | Cytologically and histopathologically confirmed percursors of cervical cancer. | Measured from the date of the summons until 12 months after the summons | 
| Rate of cancer | Histopathologically confirmed cervical cancers. | Measured from the date of the summons until 12 months after the summons | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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participation, self sampling, screening