Research Project on Reminders and Self-Sampling Can Increase Participation in Gynecology Cell Sampling - Preventive Examination Against Cervical Cancer.

Who is this study for? Older adult female patients that live in the Skane region that have had Glandular Cell Transformation
What treatments are being studied? Polymerase Chain Reaction+Cobas Swab Sample
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 33
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Sweden
Western Region
RECRUITING
Gothenburg
Southeast Region
RECRUITING
Jönköping
Northern Region
RECRUITING
Luleå
Southern Region
RECRUITING
Lund
Region of Stockholm-Gotland
RECRUITING
Stockholm
Region of Middle Sweden
RECRUITING
Uppsala
Contact Information
Primary
Miriam Elfström, PhD
Miriam.elfstrom@sll.se
+46(0)703816277
Backup
Helena Andersson, PhD
helena.andersson.1@ki.se
+46-858581894
Time Frame
Start Date: 2019-08-19
Estimated Completion Date: 2030-06-01
Participants
Target number of participants: 20000
Treatments
Other: 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.
Related Therapeutic Areas
Sponsors
Leads: Karolinska Institutet
Collaborators: Region Skane

This content was sourced from clinicaltrials.gov