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

NCT06647992 | Completed DMC

• 1 other identifier: SaglikBilimleriU-ON-TO-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Cancers

Keywords

Uterine Cervical Neoplasms; Patient Navigation; Transtheoretical Model; Health behavior

Outcome Measures

Primary Outcomes (1)

• Health Belief Model Scale for Cervical Cancer and Pap Smear Test: Psychometric testing

  Health Belief Model Scale for Cervical Cancer and Pap Smear Test: Psychometric testing consists of 35 items grouped into five subscales. 1. Pap smear Benefit (items 18.-22.) and Health Motivation (items 11.-14.) subscales 2. Pap smear Perception of obstacle (items 23-36) subscale, 3. Cervical cancer severity perception (Items 4-10) subscale, 4. Cervical cancer sensitivity perception (Items 1 - 3) subscale, 5. Health Motivation subscale (items 15-17) A 5-point Likert scale ranging from 1 to 5 - "strongly disagree" (1), "disagree" (2), "undecided" (3), "agree" (4), "strongly agree" (5) - was used to assess the scale. Each dimension of the scale is evaluated separately and not combined into a single total score. For each individual, as many points are obtained as the number of sub-dimensions.

  Pre-test, 3rd month post-test, 6th month post-test

Study Arms (2)

Intervention group- Nurse Navigation Program

EXPERIMENTAL

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.

Behavioral: Nurse Navigation Program

control group- Standardised Education

NO INTERVENTION

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.

Interventions

Nurse Navigation Program 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.

Intervention group- Nurse Navigation Program

Eligibility Criteria

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

You may qualify if:

• Women aged between 30 and 65 years, able to use the WhatsApp application, not undergoing regular cervical cancer screening, with no history of gynecological cancer, currently or previously sexually active, and voluntarily willing to participate in the study.

You may not qualify if:

• Women who had a current diagnosis or history of gynecological cancer, were undergoing regular cervical cancer screening, were unable to use the WhatsApp application, had never been sexually active, or did not provide voluntary consent to participate in the study.

Sponsors & Collaborators

• TURKAN OZDAS: lead

Study Sites (1)

Saglık Bilimleri University

Istanbul, Üsküdar, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Health Behavior

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; Behavior

Study Officials

• Turkan Ozdas

  Saglık Bilimleri University

  PRINCIPAL INVESTIGATOR

• Donmez Elif

  Saglık Bilimleri University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Oncology Nursing PhD Student

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 18, 2024
• Study Start: September 13, 2024
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)