Effect of Nurse Navigation Program on Cervical Cancer Screening Behaviour of the Women Aged 30-65

NCT ID: NCT06647992

Last Updated: 2024-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-13

Study Completion Date

2025-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study was designed as a randomized controlled experimental study to examine the effect of the 'Nurse Navigation Program' on cervical cancer screening behaviors (Human Papilloma Virus (HPV) DNA screening test and/or pap smear test) and health beliefs about cervical cancer screening in women aged 30-65 years.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

An important step in the fight against cervical cancer is access to early diagnosis, early screening culture and the creation of screening opportunities. Problems in access to health services, barriers and cultural reasons play an important role in participation in cervical cancer screening. Nurse The Navigation Program is important to help individuals overcome and cope with these barriers. There are international studies showing the positive effect of the nurse navigation program on cervical cancer screening behaviors. However, it is thought that this study will contribute to the literature because the number of studies on this subject is not sufficient and no research is found in national sources.

It is aimed to contribute to overcoming the problems and obstacles in front of the patients' access to cervical cancer screening with the Nurse Navigation Program application developed based on the Transtheoretical Model to the experimental group and to provide evidence for the nurse navigation program application to be a method used in the cervical cancer screening process.

The population of the study will consist of female members of Non-Governmental Organizations in the 30-65 age group. The data of the study will be collected between September 13, 2024 and February 15, 2025 after ethics committee approval and institutional permission. The design of the study is a randomized controlled experimental study.

The data will be collected using the Individual Descriptive Information Form, Information Questions on Reproductive Health and Sexual Life, Questions on Cervical Cancer and Screening, Questions on HPV Knowledge, Cervical Cancer and Pap Smear Test Health Belief Model Scale. The statistical data obtained as a result of the research will be analyzed using the SPSS package program. It is expected that the rate of having HPV-DNA test and Pap smear test is higher in the experimental group in which the nurse navigation program is applied compared to the control group in which the intervention is not applied, and the mean score of benefit perception of cervical cancer screening behaviors (HPV DNA and/or Pap smear) is expected to be significantly different in the group in which the nurse navigation program is applied compared to the group in which it is not applied.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Cancers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group- Nurse Navigation Program

The standard education and information booklet will be applied to both the experimental and control groups. Nurse navigation program will be applied to the experimental group. Within the navigation program, HPV DNA and Pap Smear Test Training and Counseling, Nurse Managed Telephone Support Line, Reminder Telephone Message, Transtheoretical Model and Motivational Interviews will be applied to individuals. Health Belief Model Scale for Cervical Cancer and Pap Smear Test: Psychometric testing is planned to be applied to both groups before and after the intervention in terms of outcome variables at 3 and 6 months.

Group Type EXPERIMENTAL

Nurse Navigation Program

Intervention Type BEHAVIORAL

It is planned to provide "Cervical Cancer Education and Counseling" to women in the experimental group about cervical cancer. Training and counseling is planned to be implemented face to face. An information booklet will be given to the experimental group. After 30 and 60 days after the training and counseling given to the experimental and control groups, it was planned to provide online (WhatApp) training and counseling to the patients in the experimental group:

Participants will be given a contact number that they can reach during the day when they want to receive counseling about HPV-DNA or Pap smear. Interviews will be scheduled between 08.00-20.00.

Individuals who are not screened will receive a reminder message by phone on the 45th and 75th day. Transtheoretical Model In the study, interventions will be planned for the experimental group according to the stages of the transtheoretical model.

The researcher will conduct motivational interviews with the individuals.

control group- Standardised Education

It was planned to give "Cervical Cancer Education and Information Booklet" to the women in the control group about cervical cancer. Health Belief Model Scale for Cervical Cancer and Pap Smear Test: Psychometric testing was planned to be applied before and after the standard education and booklet in terms of outcome variables at 3 and 6 months.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nurse Navigation Program

It is planned to provide "Cervical Cancer Education and Counseling" to women in the experimental group about cervical cancer. Training and counseling is planned to be implemented face to face. An information booklet will be given to the experimental group. After 30 and 60 days after the training and counseling given to the experimental and control groups, it was planned to provide online (WhatApp) training and counseling to the patients in the experimental group:

Participants will be given a contact number that they can reach during the day when they want to receive counseling about HPV-DNA or Pap smear. Interviews will be scheduled between 08.00-20.00.

Individuals who are not screened will receive a reminder message by phone on the 45th and 75th day. Transtheoretical Model In the study, interventions will be planned for the experimental group according to the stages of the transtheoretical model.

The researcher will conduct motivational interviews with the individuals.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 30-65 years old,
* With health insurance,
* No history of gynecologic cancer,
* Current or past active sexual life
* Women who agreed to participate in the study

Exclusion Criteria

* Diagnosed with gynecologic cancer,
* The one who had a hysterectomy,
* Who do not want to be involved in the study,
* No previous sexual experience,
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

TURKAN OZDAS

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

TURKAN OZDAS

Oncology Nursing PhD Student

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Turkan Ozdas

Role: PRINCIPAL_INVESTIGATOR

Saglık Bilimleri University

Donmez Elif

Role: STUDY_DIRECTOR

Saglık Bilimleri University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Saglık Bilimleri University

Istanbul, Üsküdar, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SaglikBilimleriU-ON-TO-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Screening for Early Cervical Cancer Detection
NCT06550583 ACTIVE_NOT_RECRUITING