Cervical Cancer Clinical Trial
Official title:
Can SMS-reminders Result in Increased Participation in Cervical Screening?
Prevention of cervical cancer with cervical screening is one of the most successful screening activities in medicine. In Sweden, screening was implemented in the 1960s and has since prevented tens of thousands of women from having cervical cancer. Individual invitations to screening result in increased attendance therefore evaluating strategies for reaching women through invitations is particularly valuable. Women who regularly attend screening following an invitation reduce their risk of cervical cancer by as much as 90%. Of the women who are diagnosed with 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. The current coverage of screening is 82.9%, which represents the proportion of women ages 23-70 who attend according to recommendations. In addition, many women are sporadic attenders who reduce their risk for cancer somewhat. The highest cancer risk is seen among those women who have never participated as well as women who have had a history of precancerous lesions or HPV infection but have not been followed-up. Cervical cancer is the first form of cancer for which there are approved molecular screening tests (HPV test). Unlike the older screening method (cytology), self-collected samples can 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 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.
Status | Recruiting |
Enrollment | 20000 |
Est. completion date | June 1, 2030 |
Est. primary completion date | June 1, 2030 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 33 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Western Region | Gothenburg | Västra Götaland |
Sweden | Southeast Region | Jönköping | |
Sweden | Northern Region | Luleå | Norrbotten |
Sweden | Southern Region | Lund | Skåne |
Sweden | Region of Stockholm-Gotland | Stockholm | |
Sweden | Region of Middle Sweden | Uppsala |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Region Skane |
Sweden,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Number of positive screens | Screening test results | Measured from the date of the summons until 12 months after the summons | |
Secondary | 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 | |
Secondary | Rate of cancer | Histopathologically confirmed cervical cancers. | Measured from the date of the summons until 12 months after the summons |
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