NCT06252012

Brief Summary

Cervical cancer is one of the most common cancer types affecting women in our country and in the world and causing morbidity. However, the availability of a vaccine for cervical cancer, preventable risk factors and early diagnosis tests offer a unique opportunity to reduce the rate of cervical cancer. In this context, there are studies showing that the practices developed by policies differ and that the classical health approach is insufficient. The effectiveness of the trainings given may vary according to time, place, trainer and personal characteristics of the individual. At the same time, in order to improve the attitudes and behaviours of individuals in terms of prevention and early diagnosis of cervical cancer, awareness of individuals about cervical cancer should be increased. In this way, women will have a say about their own health and their conscious participation in health care services will be realised. Therefore, the aim of this project is to apply cervical cancer awareness training to women and to examine its effect on women's cervical cancer prevention and early diagnosis behaviours. Original value; The fact that there is no mobile application developed for cervical cancer in Turkey reveals the national value of the research. In addition, the mobile application has international unique value as it is the first mobile application structured to provide awareness on cervical cancer prevention and early diagnosis behaviours. The project method was planned for the development and implementation of the mobile application programme. The research design will be a randomised controlled study. The 120 women who meet the inclusion criteria and who apply to more than one family health centre will be randomly assigned to the intervention and control groups. The effect of the mobile application programme on women's attitudes and behaviours towards cervical cancer prevention and early diagnosis will be evaluated at the 6th and 12th weeks. In the evaluation of the data, t-test for independent groups, anova and chi-square tests will be used to measure the effect of the intervention. Widespread effect; In this way, it is planned to reduce the time spent by professionals for care-related activities, to strengthen time management, to provide advantages and improvements in the performance of nurses in patient care management by using technological resources in the health care provided.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2023

Completed
9 months until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2025

Completed
Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

7 months

First QC Date

May 4, 2023

Last Update Submit

June 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mobile application development

    The effectiveness of the mobile application created for cervical cancer awareness will be evaluated with the Mobile Application Usability Scale-MAUS Scale (Mobile Application Usability Scale-MAUS Scale at Week 12). It has a total of 40 items and 7-point Likert type (1=strongly disagree, 7=completely agree). The range of points that can be obtained from the scale is 42-294. The increase in the score indicates that the usability level of the mobile application is high. There are no items that need to be reverse coded in the scale.

    3 months

Secondary Outcomes (3)

  • effect of the developed mobile application on cervical cancerearly diagnosis attitudes measured by the Attitude Towards Early Diagnosis of Cervical Cancer Scale

    3 months

  • effect of the developed mobile application on cervical cancer prevention attitudes measured by the Attitude Scale for Cervical Cancer Prevention

    3 months

  • ffect of the developed mobile application on cervical cancer awareness behaviors measured by the Cervical cancer awareness behaviour questionnaire

    3 month

Study Arms (2)

Mobile Application Group

EXPERIMENTAL

Within the scope of the mobile application, information modules on cervical cancer screening tests, cervical cancer risk factors, ways to prevent cervical cancer, types of HPV, and HPV vaccine will be provided. A parallel-group pretest-posttest randomized controlled trial design will be used in the second stage of the study.

Behavioral: Mobile application

Control Group

NO INTERVENTION

The relevant brochures of the Ministry of Health on the prevention of cervical cancer will be given to the experimental and control groups.

Interventions

The mobile application will be designed as a health assistant for women aged between 30-65 to encourage healthy choices and positively develop their behaviors regarding the prevention of cancer. Within the scope of the mobile application, information modules on cervical cancer screening tests, cervical cancer risk factors, ways to prevent cervical cancer, types of HPV, and HPV vaccine will be provided. A parallel-group pretest-posttest randomized controlled trial design will be used in the second stage of the study

Mobile Application Group

Eligibility Criteria

Age35 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSince cervical cancer is seen in women, the study was based on gender.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • She applied to Yıldırım Beyazıt Family Health Center and Zafertepe Family Health Center in Kütahya.
  • No pregnancy or malignancy,
  • No hearing and vision problems,
  • Between the ages of 30-65,
  • Having a smart phone,
  • sexually active
  • Can read and write Turkish,
  • Have not had a pap-smear test in the last 5 years,

You may not qualify if:

  • Pregnancy women Breastfeeding Have a history of cancer Have undergone hysterectomy operation Those who have undergone an operation for cervical cancer (cryosurgery, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Science University

Kütahya, Merkez, 43000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Sena F Karakışla, MSc

    Akdeniz University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
assigned randomly via ramdom.org
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A mobile application developed to increase awareness of cervical cancer among 60 women in the intervention group who met the sample criteria was implemented.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 4, 2023

First Posted

February 9, 2024

Study Start

April 1, 2024

Primary Completion

October 21, 2024

Study Completion

May 27, 2025

Last Updated

July 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations