Clinic or Self-Sampling for Cervical Cancer Screening

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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer; HPV Infection
• Intervention / Treatment: Diagnostic test: cervical cancer screening

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34000
    • Istanbul Unıversıty-Cerrahpasa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria: Must be able to perform self-test

Exclusion Criteria: pregnancy, diagnosing the cervix

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: randomıze; 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; The aim of this project was to determine the effect of clinic or self-sampling on attendance, attitudes, and anxiety in cervical cancer screening.

What is the study measuring?

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

Other 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 Anxiety	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.	1 year

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa (IUC)
• Collaborators: Health Institutes of Turkey
• Investigators: Principal Investigator: Özge Şen, Istanbul University - Cerrahpasa (IUC)

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Estimated): December 20, 2023

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: cervical cancer; HPV testing
• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms; Papillomavirus Infections
• Other Study ID Numbers: stanbulUC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No