Follow-up of Abnormal and Inadequate Smear-test Results

Study Overview
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Brief Summary
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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: 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 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.

Official Title
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Follow-up of Abnormal and Inadequate Test Results in the Danish Cervical Cancer Screening Program.

Conditions
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Carcinoma in Situ of Uterine Cervix

Intervention / Treatment
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* Other: Test result sent by letter
* Other: Test result conveyed by general practitioners


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

Ages Eligible for Study
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Minimum Age: 23 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test result sent by letter<br>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<br> <br> Other: Test result conveyed by general practitioners<br> <br> |
| Active Comparator: Test result conveyed by general practitioners<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of general practitioner contacts (consultations/telephone calls /e-mails) regarding conveying the smear test result. | The two randomisation groups will be compared with respect to contacts with general practitioner after the smear test the first days, weeks, months after the general practitioner is notified of the screening result. | Three months after the smear test. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Risk Communication, Follow-up, Organisation of screening