Effect of Fee on Attendance in Cervical Cancer Screening

February 27, 2015 updated by: Göteborg University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3124

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention and control
Intervention arm: screening without fee.
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.
No Intervention: Control group
Control arm: screening with the regular fee, 100SEK.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in attendance
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in attendance stratified for age groups, home districts and previous pap smear history.
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Investigators

  • Study Director: Björn Strander, PhD, Regional Cancer Center West

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

January 5, 2015

First Submitted That Met QC Criteria

February 27, 2015

First Posted (Estimate)

March 4, 2015

Study Record Updates

Last Update Posted (Estimate)

March 4, 2015

Last Update Submitted That Met QC Criteria

February 27, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ScreenFee

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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