Follow-up of Abnormal and Inadequate Smear-test Results
Primary Purpose
Carcinoma in Situ of Uterine Cervix
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Test result sent by letter
Test result conveyed by general practitioners
Sponsored by
About this trial
This is an interventional health services research trial for Carcinoma in Situ of Uterine Cervix focused on measuring Risk Communication, Follow-up, Organisation of screening
Eligibility Criteria
Inclusion Criteria:
- woman with a pap-smear test
Exclusion Criteria:
- less than 23 years
Sites / Locations
- University of Aarhus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test result sent by letter
Test result conveyed by general practitioners
Arm Description
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.
In Denmark it is a standard procedure that general practitioners convey the pap-smear test results to the women.
Outcomes
Primary Outcome Measures
Proportion of women with timely follow-up
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
Frequency of general practitioner contacts (consultations/telephone calls /e-mails) regarding conveying the smear test result.
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.
Full Information
NCT ID
NCT02002468
First Posted
November 29, 2013
Last Updated
September 14, 2016
Sponsor
University of Aarhus
1. Study Identification
Unique Protocol Identification Number
NCT02002468
Brief Title
Follow-up of Abnormal and Inadequate Smear-test Results
Official Title
Follow-up of Abnormal and Inadequate Test Results in the Danish Cervical Cancer Screening Program.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
February 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma in Situ of Uterine Cervix
Keywords
Risk Communication, Follow-up, Organisation of screening
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test result sent by letter
Arm Type
Experimental
Arm Description
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.
Arm Title
Test result conveyed by general practitioners
Arm Type
Active Comparator
Arm Description
In Denmark it is a standard procedure that general practitioners convey the pap-smear test results to the women.
Intervention Type
Other
Intervention Name(s)
Test result sent by letter
Intervention Type
Other
Intervention Name(s)
Test result conveyed by general practitioners
Primary Outcome Measure Information:
Title
Proportion of women with timely follow-up
Description
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).
Time Frame
1½ year
Secondary Outcome Measure Information:
Title
Frequency of general practitioner contacts (consultations/telephone calls /e-mails) regarding conveying the smear test result.
Description
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.
Time Frame
Three months after the smear test.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
woman with a pap-smear test
Exclusion Criteria:
less than 23 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Vedsted
Organizational Affiliation
Center for Research in Cancer Diagnosis in Primary Care - (CaP), Aarhus University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Flemming Bro
Organizational Affiliation
The Research Unit of General Practice in Aarhus, Aarhus University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Berit S Andersen
Organizational Affiliation
The Department of Public Health Programmes at Regional Hospital Randers
Official's Role
Study Director
Facility Information:
Facility Name
University of Aarhus
City
Aarhus
State/Province
Central Denmark Region
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
30568870
Citation
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.
Results Reference
derived
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Follow-up of Abnormal and Inadequate Smear-test Results
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