Effect of Fee on Attendance in Cervical Cancer Screening
Primary Purpose
Cervical Dysplasia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Screening without fee
Sponsored by
About this trial
This is an interventional screening trial for Cervical Dysplasia focused on measuring Attendance, Screening without fee
Eligibility Criteria
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:
- None
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention and control
Control group
Arm Description
Intervention arm: screening without fee.
Control arm: screening with the regular fee, 100SEK.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02378324
Brief Title
Effect of Fee on Attendance in Cervical Cancer Screening
Official Title
Effect of Fee on Attendance in Cervical Cancer Screening-results From ScreenFee a Swedish Population Based Randomised Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dysplasia
Keywords
Attendance, Screening without fee
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
3124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention and control
Arm Type
Active Comparator
Arm Description
Intervention arm: screening without fee.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control arm: screening with the regular fee, 100SEK.
Intervention Type
Other
Intervention Name(s)
Screening without fee
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in attendance
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Differences in attendance stratified for age groups, home districts and previous pap smear history.
Description
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.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Björn Strander, PhD
Organizational Affiliation
Regional Cancer Center West
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
23233356
Citation
Broberg G, Jonasson JM, Ellis J, Gyrd-Hansen D, Anjemark B, Glantz A, Soderberg 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.
Results Reference
background
PubMed Identifier
18445828
Citation
Andrae B, Kemetli L, Sparen P, Silfverdal L, Strander B, Ryd W, Dillner J, Tornberg 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.
Results Reference
background
PubMed Identifier
9678615
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. doi: 10.1177/030089169808400307.
Results Reference
background
PubMed Identifier
15006907
Citation
Eaker S, Adami HO, Granath F, Wilander E, Sparen 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.
Results Reference
background
PubMed Identifier
24127304
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.
Results Reference
background
PubMed Identifier
21730977
Citation
Wikstrom 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.
Results Reference
background
PubMed Identifier
12366488
Citation
Idestrom M, Milsom I, Andersson-Ellstrom 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. doi: 10.1080/j.1600-0412.2002.811011.x.
Results Reference
background
PubMed Identifier
26986848
Citation
Alfonzo E, Andersson Ellstrom A, Nemes S, Strander B. Effect of Fee on Cervical Cancer Screening Attendance--ScreenFee, a Swedish Population-Based Randomised Trial. PLoS One. 2016 Mar 17;11(3):e0150888. doi: 10.1371/journal.pone.0150888. eCollection 2016.
Results Reference
derived
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Effect of Fee on Attendance in Cervical Cancer Screening
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