This trial is active, not recruiting.

Condition carcinoma in situ of uterine cervix
Treatments test result sent by letter, test result conveyed by general practitioners
Sponsor University of Aarhus
Start date October 2012
End date October 2014
Trial size 125000 participants
Trial identifier NCT02002468, Cervix cancer screening


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
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
(Active Comparator)
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

Primary Outcomes

Proportion of women with timely follow-up
time frame: 1½ year

Secondary Outcomes

Frequency of general practitioner contacts (consultations/telephone calls /e-mails) regarding conveying the smear test result.
time frame: Three months after the smear test.

Eligibility Criteria

Female participants at least 23 years old.

Inclusion Criteria: - woman with a pap-smear test Exclusion Criteria: - less than 23 years

Additional Information

Official title Follow-up of Abnormal and Inadequate Test Results in the Danish Cervical Cancer Screening Program.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Aarhus.