Follow-up of Abnormal and Inadequate Smear-test Results

Carcinoma in Situ of Uterine Cervix Clinical Trial

Official title:

Follow-up of Abnormal and Inadequate Test Results in the Danish Cervical Cancer Screening Program.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02002468
• Other study ID #: Cervix cancer screening
• Status: Active, not recruiting
• Phase: N/A
• First received: November 29, 2013
• Last updated: September 14, 2016
• Start date: October 2012
• Est. completion date: February 2017

Study information

• Verified date: December 2015
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Danish National Committee on Biomedical Research EthicsDenmark: Centre for Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 125000
• Est. completion date: February 2017
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 23 Years and older

Eligibility

Inclusion Criteria:

• woman with a pap-smear test

Exclusion Criteria:

• less than 23 years

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Carcinoma in Situ
• Carcinoma in Situ of Uterine Cervix
• Cervical Intraepithelial Neoplasia

Intervention

Other:
• Test result sent by letter

• Test result conveyed by general practitioners

Locations

Country	Name	City	State
Denmark	University of Aarhus	Aarhus	Central Denmark Region

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1½ year	No
Secondary	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.	Three months after the smear test.	No