Follow-up of Abnormal and Inadequate Smear-test Results

University of Aarhus

Status: Unknown

Conditions: Carcinoma in Situ of Uterine Cervix

Treatments: Other: Test result sent by letter; Other: Test result conveyed by general practitioners

Study type: Interventional

Funder types: Other

Identifiers

NCT02002468

Cervix cancer screening

Details and patient eligibility

About

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.

Enrollment: 125,000 estimated patients

Sex: Female

Ages: 23+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• woman with a pap-smear test

Exclusion criteria

• less than 23 years

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125,000 participants in 2 patient groups

Test result sent by letter

Experimental group

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.

Treatment:

Other: Test result conveyed by general practitioners

Other: Test result sent by letter

Test result conveyed by general practitioners

Active Comparator group

Description:

In Denmark it is a standard procedure that general practitioners convey the pap-smear test results to the women.

Treatment:

Other: Test result conveyed by general practitioners