Actively Recruiting

Phase Not Applicable
Age: 33Years - 75Years
FEMALE
NCT04061967

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

Led by Karolinska Institutet · Updated on 2025-01-14

20000

Participants Needed

6

Research Sites

562 weeks

Total Duration

On this page

Sponsors

K

Karolinska Institutet

Lead Sponsor

R

Region Skane

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 33Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women resident in Region Skane who have had glandular cell changes not followed up
  • Women older than 65 years with cell changes not followed up or no screening participation in the last 10 years
  • Women who have not had a cervical screening test for more than 15 years
Not Eligible

You will not qualify if you...

  • Women who do not consent to participate

AI-Screening

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Trial Site Locations

Total: 6 locations

1

Northern Region

Luleå, Norrbotten County, Sweden, 901 87

Actively Recruiting

2

Southern Region

Lund, Skåne County, Sweden, 221 00

Actively Recruiting

3

Western Region

Gothenburg, Västra Götaland County, Sweden, 413 45

Actively Recruiting

4

Southeast Region

Jönköping, Sweden, 581 85

Actively Recruiting

5

Region of Stockholm-Gotland

Stockholm, Sweden, 112 18

Actively Recruiting

6

Region of Middle Sweden

Uppsala, Sweden, 751 85

Actively Recruiting

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Research Team

M

Miriam Elfström, PhD

CONTACT

H

Helena Andersson, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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