Follow-up of Abnormal and Inadequate Smear-test Results

NCT02002468 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125000

Last updated 2016-09-15

No results posted yet for this study

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.

Conditions

  • Carcinoma in Situ of Uterine Cervix

Interventions

OTHER

Test result sent by letter

OTHER

Test result conveyed by general practitioners

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Peter Vedsted · Center for Research in Cancer Diagnosis in Primary Care - (CaP), Aarhus University

  • Flemming Bro · The Research Unit of General Practice in Aarhus, Aarhus University

  • Berit S Andersen · The Department of Public Health Programmes at Regional Hospital Randers

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
23 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-10-31
Completion
2017-02-28

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02002468 on ClinicalTrials.gov