Follow-up of Abnormal and Inadequate Smear-test Results
NCT ID: NCT02002468
Last Updated: 2016-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
125000 participants
INTERVENTIONAL
2012-10-31
2017-02-28
Brief Summary
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Annually 40 000 women receives an abnormal or inadequate test result and a follow-up recommendation.
However problems with delayed follow-up may threaten the effectiveness of the Danish Cervical Cancer Screening Program, as 20% of women are delayed and dysplasia potentially can progress into cancer.
Delayed follow-up is found in situations where women either consciously or unconsciously postpone follow-up, or because of organizational aspects of the screening program, where communication regarding test results can fail either in content or with delay.This study will evaluate two interventions designed to increase follow-up:
1. A letter with the test result and potential recommendation for follow up will be sent to the women (RCT). The intention is to ensure that all women will be notified about the test result, quickly, homogenously and in layman's written language, still with the opportunity to contact or be contacted by the general practitioner, if there is special needs. Furthermore, it is assumed that general practitioner consultations regarding delivery of normal test results will decrease, so that cost savings is a potential side benefit
2. Electronic reminder to the general practitioner if women have not had the recommended follow up, giving the general practioner´s an opportunity to remind the women (retro perspective cohort study).
The results will be of great importance to the future organisation of cervical and colorectal cancer screening programmes in Denmark, but will also have international interest because of their similar challenges.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Test result sent by letter
The pap-smear test result is sent by letter directly to the women. Women in need of follow up are in the letter recommended to contact their general practitioner.
Test result sent by letter
Test result conveyed by general practitioners
Test result conveyed by general practitioners
In Denmark it is a standard procedure that general practitioners convey the pap-smear test results to the women.
Test result conveyed by general practitioners
Interventions
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Test result sent by letter
Test result conveyed by general practitioners
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
23 Years
FEMALE
Yes
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Peter Vedsted
Role: STUDY_DIRECTOR
Center for Research in Cancer Diagnosis in Primary Care - (CaP), Aarhus University
Flemming Bro
Role: STUDY_DIRECTOR
The Research Unit of General Practice in Aarhus, Aarhus University
Berit S Andersen
Role: STUDY_DIRECTOR
The Department of Public Health Programmes at Regional Hospital Randers
Locations
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University of Aarhus
Aarhus, Central Jutland, Denmark
Countries
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References
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Kristiansen BK, Andersen B, Bro F, Svanholm H, Vedsted P. Direct notification of cervical cytology results to women improves follow-up in cervical cancer screening - A cluster-randomised trial. Prev Med Rep. 2018 Nov 23;13:118-125. doi: 10.1016/j.pmedr.2018.11.015. eCollection 2019 Mar.
Other Identifiers
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Cervix cancer screening
Identifier Type: -
Identifier Source: org_study_id
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