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Follow-up of Abnormal and Inadequate Smear-test Results

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ClinicalTrials.gov Identifier: NCT02002468
Recruitment Status : Unknown
Verified December 2015 by University of Aarhus.
Recruitment status was:  Active, not recruiting
First Posted : December 5, 2013
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

Denmark has a higher incidence of cervical cancer than other Nordic countries, although all Danish women (aged 23-65) are screened regularly to identify possible cervical dysplasia or asymptomatic invasive cancer.

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.


Condition or disease Intervention/treatment Phase
Carcinoma in Situ of Uterine Cervix Other: Test result sent by letter Other: Test result conveyed by general practitioners Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Follow-up of Abnormal and Inadequate Test Results in the Danish Cervical Cancer Screening Program.
Study Start Date : October 2012
Actual Primary Completion Date : October 2014
Estimated Study Completion Date : February 2017

Arm Intervention/treatment
Experimental: 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.
Other: Test result sent by letter
Other: Test result conveyed by general practitioners
Active Comparator: 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.
Other: Test result conveyed by general practitioners



Primary Outcome Measures :
  1. Proportion of women with timely follow-up [ Time Frame: 1½ year ]
    The proportion of women followed up will be calculated as cumulated incidence proportions according to four timeframes (undesirable early, as recommended, late, very late), and be compared by relative risks. The results will be presented in totals and separately depending on the test result (normal/inadequate/Bethesda classification 2001/HPV).


Secondary Outcome Measures :
  1. Frequency of general practitioner contacts (consultations/telephone calls /e-mails) regarding conveying the smear test result. [ Time Frame: Three months after the smear test. ]
    The two randomisation groups will be compared with respect to contacts with general practitioner after the smear test the first days, weeks, months after the general practitioner is notified of the screening result.



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Ages Eligible for Study:   23 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • woman with a pap-smear test

Exclusion Criteria:

  • less than 23 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002468


Locations
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Denmark
University of Aarhus
Aarhus, Central Denmark Region, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
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Study Director: Peter Vedsted Center for Research in Cancer Diagnosis in Primary Care - (CaP), Aarhus University
Study Director: Flemming Bro The Research Unit of General Practice in Aarhus, Aarhus University
Study Director: Berit S Andersen The Department of Public Health Programmes at Regional Hospital Randers
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02002468    
Other Study ID Numbers: Cervix cancer screening
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: December 2015
Keywords provided by University of Aarhus:
Risk Communication
Follow-up
Organisation of screening
Additional relevant MeSH terms:
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Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms