Follow-up of Abnormal and Inadequate Smear-test Results

NCT02002468 | Unknown

• 1 other identifier: Cervix cancer screening
• Study Type: interventional
• Target: 125,000
• Locations: 1 country
• Sites: 1

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. 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. 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).

Conditions

Carcinoma in Situ of Uterine Cervix

Keywords

Risk Communication; Follow-up; Organisation of screening

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Frequency of general practitioner contacts (consultations/telephone calls /e-mails) regarding conveying the smear test result.

  Three months after the smear test.

Study Arms (2)

Test result sent by letter

EXPERIMENTAL

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.

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

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.

Other: Test result conveyed by general practitioners

Interventions

Test result sent by letter OTHER

Test result sent by letter

Test result conveyed by general practitioners OTHER

Test result conveyed by general practitioners; Test result sent by letter

Eligibility Criteria

• Age: 23 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• woman with a pap-smear test

You may not qualify if:

• less than 23 years

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

University of Aarhus

Aarhus, Central Jutland, 8000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 30568870 DERIVED

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Peter Vedsted

  Center for Research in Cancer Diagnosis in Primary Care - (CaP), Aarhus University

  STUDY DIRECTOR

• Flemming Bro

  The Research Unit of General Practice in Aarhus, Aarhus University

  STUDY DIRECTOR

• Berit S Andersen

  The Department of Public Health Programmes at Regional Hospital Randers

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2013
• First Posted: December 5, 2013
• Study Start: October 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: February 1, 2017
• Last Updated: September 15, 2016

Record last verified: 2015-12

Locations

DK (1)