Effect of Fee on Attendance in Cervical Cancer Screening

Cervical Dysplasia Clinical Trial

Official title:

Effect of Fee on Attendance in Cervical Cancer Screening-results From ScreenFee a Swedish Population Based Randomised Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02378324
• Other study ID #: ScreenFee
• Status: Completed
• Phase: N/A
• First received: January 5, 2015
• Last updated: February 27, 2015
• Start date: January 2013
• Est. completion date: July 2013

Study information

• Verified date: February 2015
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

Several reasons can explain non-attendance in cervical cancer screening. In low resource settings the attendance is even lower. The effect of fee as contributing reason of non attendance has not been studied before why the investigators decided to study this in a low resource setting as a randomised trial.

Description:

Non-attendance in the cervical cancer screening programme is the most important factors why Swedish women contract the disease. Low attendance rate is observed in districts with low socioeconomic resources. Several reasons can explain this, including the existence of a fee. A low attendance rate in low resource districts is also noticed in Gothenburg, Sweden. After multiple interventions the coverage has slightly increased. None of the interventions included the aspect of the fee. The investigators decided to study the effect of fee abolishment in a randomized control trial emanating from the regular cervical cancer-screening program. Method: Randomized Control Trial (RCT). Women in low resource areas of Gothenburg, due for screening, January-July 2013, were randomised to receive an offer of a free test or receiving the regular invitation stating the regular fee of 100 Swedish kronor (SEK) (≈11 €). Power calculation has shown 80 % power to detect an increase in participation of 20% at 1972 participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3124
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 23 Years to 60 Years

Eligibility

Inclusion Criteria:

• All women in the designated geographical area, consecutively enrolled in planned screening according to standard routine. I.e women are invited if they are between 23 and 60 years of age and don't have a pap smear registered the last three or five years according to age.

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Screening

Related Conditions & MeSH terms

• Cervical Dysplasia
• Cervical Intraepithelial Neoplasia
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

Intervention

Other:
• Screening without fee
All women in three districts in Gothenburg, Sweden, that were eligible for invitation in the regular screening program were individually randomized by computer program in two parallel arms 1:1.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

References & Publications (7)

Andrae B, Kemetli L, Sparén P, Silfverdal L, Strander B, Ryd W, Dillner J, Törnberg S. Screening-preventable cervical cancer risks: evidence from a nationwide audit in Sweden. J Natl Cancer Inst. 2008 May 7;100(9):622-9. doi: 10.1093/jnci/djn099. Epub 2008 Apr 29. — View Citation

Broberg G, Gyrd-Hansen D, Miao Jonasson J, Ryd ML, Holtenman M, Milsom I, Strander B. Increasing participation in cervical cancer screening: offering a HPV self-test to long-term non-attendees as part of RACOMIP, a Swedish randomized controlled trial. Int J Cancer. 2014 May 1;134(9):2223-30. doi: 10.1002/ijc.28545. Epub 2013 Oct 31. — View Citation

Broberg G, Jonasson JM, Ellis J, Gyrd-Hansen D, Anjemark B, Glantz A, Söderberg L, Ryd ML, Holtenman M, Milsom I, Strander B. Increasing participation in cervical cancer screening: telephone contact with long-term non-attendees in Sweden. Results from RACOMIP, a randomized controlled trial. Int J Cancer. 2013 Jul;133(1):164-71. doi: 10.1002/ijc.27985. Epub 2013 Jan 10. — View Citation

Eaker S, Adami HO, Granath F, Wilander E, Sparén P. A large population-based randomized controlled trial to increase attendance at screening for cervical cancer. Cancer Epidemiol Biomarkers Prev. 2004 Mar;13(3):346-54. — View Citation

Ideström M, Milsom I, Andersson-Ellström A. Knowledge and attitudes about the Pap-smear screening program: a population-based study of women aged 20-59 years. Acta Obstet Gynecol Scand. 2002 Oct;81(10):962-7. — View Citation

Segnan N, Senore C, Giordano L, Ponti A, Ronco G. Promoting participation in a population screening program for breast and cervical cancer: a randomized trial of different invitation strategies. Tumori. 1998 May-Jun;84(3):348-53. — View Citation

Wikström I, Lindell M, Sanner K, Wilander E. Self-sampling and HPV testing or ordinary Pap-smear in women not regularly attending screening: a randomised study. Br J Cancer. 2011 Jul 26;105(3):337-9. doi: 10.1038/bjc.2011.236. Epub 2011 Jul 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in attendance	Information from the database regarding study arm was linked, via citizen unique personal number, to the National Cervical Screening Quality Register. From this database aggregated information of attendance was extracted. The effect of the intervention on attendance was calculated as relative risks.	6 months	No
Secondary	Differences in attendance stratified for age groups, home districts and previous pap smear history.	Before analysing the results of which kind of invitation the woman got, age group, previous pap smear history and district, all personal information was anonymized.	6 months	No