Clinic or Self-Sampling for Cervical Cancer Screening

Study Overview
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Brief Summary
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Objective: The aim of this project was to determine the effect of clinic or self-sampling on attendance, attitudes, and anxiety in cervical cancer screening.

Detailed Description
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Introduction: Persistent infection with high-risk HPV strains is the main cause of cervical cancer. Objective: The aim of this study was to determine the effect of clinic or self-sampling on cervical cancer screening participation, attitudes and anxiety in women. Method: The study was conducted as a descriptive and randomized controlled study between October 2022 and December 2023 in Ödemiş ASM No. 2, Ministry of Health, Republic of Turkey. The first phase of the study was conducted with 309 women and the Introductory Information Form and Attitude Scale for Early Diagnosis of Cervical Cancer were used to evaluate participation and attitudes towards cervical cancer screening. The second phase of the study was conducted as a randomized controlled trial with 110 women in the experimental (n=55) and control (n=55) groups. The women in the experimental group were trained before the procedure and were allowed to take samples from the vaginal area on their own. The women in the control group were sampled from the cervical region by the clinician. Both groups were pretested before the procedure using the Descriptive Information Form and the State Anxiety Inventory to measure anxiety. After the sampling procedure, the post-test was administered to the experimental and control groups using the State Anxiety Inventory. Results: According to the screening method preferences of the women, 34% (n=105) preferred a self-test, 18.4% (n=57) preferred a test performed by a clinician in a clinic, 3.9% (n=12) preferred no method, and 43.7% (n=135) preferred both methods. In the study, it was found that the self-test option increased participation in screening. The mean total score of the women was found to be 102.896±5.660. This result shows that women have high positive attitudes towards early diagnosis of cervical cancer. In the second stage of the study, it was observed that the descriptive characteristics of the experimental and control groups showed homogeneous distribution. While there was no significant difference between the experimental and control groups in terms of anxiety level in the pretest, it was found that the control group had a significantly higher anxiety level in the posttest. Conclusion: In this study, it was observed that women had positive attitudes towards cervical cancer screening, self-sampling increased participation in screening and decreased anxiety levels.

Official Title
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The Effect of in Clinic or Self- Sampling for Cervical Cancer Screening on Status of Particitipation, Attitude and Anxiety.

Conditions
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Cervical Cancer, HPV Infection

Intervention / Treatment
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* Diagnostic Test: cervical cancer screening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be able to perform self-test Exclusion Criteria: pregnancy, diagnosing the cervix

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 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: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: randomıze<br>Assuming that a t-test between two independent groups with 80% power, d=0.5 effect size, and t-test between two independent groups will be used in the study, it was found that there should be at least 102 women in total, including 51 self-sampling and 51 clinician sampling groups. Considering the losses that may occur during the study, it was planned to include 110 women in the sample for this phase. These women will be randomly assigned to Self-Sampling (n=55) or Clinician Sampling (n=55) groups in a 1:1 ratio using https://randomizer.org/. The self-sampling group will be trained on the subject and will be provided with a self-sampling HPV DNA test kit, while the HPV DNA test | Diagnostic Test: cervical cancer screening<br>* The aim of this project was to determine the effect of clinic or self-sampling on attendance, attitudes, and anxiety in cervical cancer screening.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Effect of in Clinic or Self-Sampling for Cervical Cancer Screening on Status of Participation | In the study, it was found that the self-test option increased participation in screening. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Effect of in Clinic or Self-Sampling for Cervical Cancer Screening on Status of ling for Cervical Cancer Screening on Status of Attitude | This result shows that women have high positive attitudes towards early diagnosis of cervical cancer. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical cancer, HPV testing