NCT02378324

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,124

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
Last Updated

March 4, 2015

Status Verified

February 1, 2015

Enrollment Period

6 months

First QC Date

January 5, 2015

Last Update Submit

February 27, 2015

Conditions

Keywords

AttendanceScreening without fee

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Differences in attendance stratified for age groups, home districts and previous pap smear history.

    6 months

Study Arms (2)

Intervention and control

ACTIVE COMPARATOR

Intervention arm: screening without fee.

Other: Screening without fee

Control group

NO INTERVENTION

Control arm: screening with the regular fee, 100SEK.

Interventions

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.

Intervention and control

Eligibility Criteria

Age23 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 23233356BACKGROUND
  • 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.

    PMID: 18445828BACKGROUND
  • 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.

    PMID: 9678615BACKGROUND
  • 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.

    PMID: 15006907BACKGROUND
  • 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.

    PMID: 24127304BACKGROUND
  • 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.

    PMID: 21730977BACKGROUND
  • 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.

    PMID: 12366488BACKGROUND
  • 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.

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

Mass ScreeningFees and Charges

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health PracticeEconomicsHealth Care Economics and Organizations

Study Officials

  • Björn Strander, PhD

    Regional Cancer Center West

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2015

First Posted

March 4, 2015

Study Start

January 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

March 4, 2015

Record last verified: 2015-02