Clinical trial NCT06177236: Clinic or Self-Sampling for Cervical Cancer Screening
Official title: The Effect of in Clinic or Self- Sampling for Cervical Cancer Screening on Status of Particitipation, Attitude and Anxiety.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
HPV Infection
Keywords: cervical cancer
HPV testing
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Health Institutes of Turkey
First posted: 2023-12-20
Enrollment: 110
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: randomized controlled trial
Primary purpose: SCREENING

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria: Must be able to perform self-test

Exclusion Criteria: pregnancy, diagnosing the cervix

Primary outcomes:
measure: The Effect of in Clinic or Self-Sampling for Cervical Cancer Screening on Status of Participation
timeFrame: 1 year
Secondary outcomes:
measure: The Effect of in Clinic or Self-Sampling for Cervical Cancer Screening on Status of ling for Cervical Cancer Screening on Status of Attitude
timeFrame: 1 year
Other outcomes:
measure: The Effect of in Clinic or Self-Sampling for Cervical Cancer Screening on Status of ling for Cervical Cancer Screening on Status of Anxiety
timeFrame: 1 year
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Unıversıty-Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Özge Şen
role: PRINCIPAL_INVESTIGATOR
References: