Clinic or Self-Sampling for Cervical Cancer Screening

NCT06177236 | Completed

• 1 other identifier: stanbulUC
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer; HPV Infection

Keywords

cervical cancer; HPV testing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The Effect of in Clinic or Self-Sampling for Cervical Cancer Screening on Status of ling for Cervical Cancer Screening on Status of Attitude

  1 year

Other Outcomes (1)

• The Effect of in Clinic or Self-Sampling for Cervical Cancer Screening on Status of ling for Cervical Cancer Screening on Status of Anxiety

  1 year

Study Arms (1)

randomıze

EXPERIMENTAL

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

Interventions

cervical cancer screening DIAGNOSTIC_TEST

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

randomıze

Eligibility Criteria

• Age: 30 Years - 65 Years
• Gender Eligibility Details: 30-65 years old
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Health Institutes of Turkey: collaborator

Study Sites (1)

Istanbul Unıversıty-Cerrahpasa

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Papillomavirus Infections

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Özge Şen

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: midwife

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 20, 2023
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)