Clinical trial NCT02002468: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Carcinoma in Situ of Uterine Cervix
Keywords: Risk Communication
Follow-up
Organisation of screening
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2013-12-05
Enrollment: 125000
Sex: FEMALE
Minimum age (years): 23
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

* woman with a pap-smear test

Exclusion Criteria:

* less than 23 years

Primary outcomes:
measure: Proportion of women with timely follow-up
timeFrame: 1½ year
Secondary outcomes:
measure: Frequency of general practitioner contacts (consultations/telephone calls /e-mails) regarding conveying the smear test result.
timeFrame: Three months after the smear test.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: University of Aarhus
state: Central Denmark Region
Study officials:
affiliation: Center for Research in Cancer Diagnosis in Primary Care - (CaP), Aarhus University
name: Peter Vedsted
role: STUDY_DIRECTOR
affiliation: The Research Unit of General Practice in Aarhus, Aarhus University
name: Flemming Bro
role: STUDY_DIRECTOR
affiliation: The Department of Public Health Programmes at Regional Hospital Randers
name: Berit S Andersen
role: STUDY_DIRECTOR
References:
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.