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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
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cervical Dysplasia focused on measuring Attendance, Screening without fee

Eligibility Criteria

23 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    January 5, 2015
    Last Updated
    February 27, 2015
    Sponsor
    Göteborg University
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    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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