Cervical CancersNCT06647992
Effect of Nurse Navigation Program on Cervical Cancer Screening Behaviour of the Women Aged 30-65
A study testing Nurse Navigation Program in people with Cervical Cancers, run by TURKAN OZDAS at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancers
- What is being tested?
- Nurse Navigation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Sep 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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
- Cervical Cancers
- Being tested
- Nurse Navigation Program
- Keywords
- Uterine Cervical Neoplasms, Patient Navigation, Transtheoretical Model, Health behavior
- Medical subject headings
- Uterine Cervical Neoplasms, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse Navigation ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- Pap smear Benefit (items 18.-22.) and Health Motivation (items 11.-14.) subscales
- Pap smear Perception of obstacle (items 23-36) subscale,
- Cervical cancer severity perception (Items 4-10) subscale,
- Cervical cancer sensitivity perception (Items 1 - 3) subscale,
- 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.
Measured: Pre-test, 3rd month post-test, 6th month post-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start13 Sep 2024
- Primary completion30 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- TURKAN OZDAS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, TURKAN OZDAS, Saglik Bilimleri Universitesi
- Investigators
- Turkan Ozdas, Principal investigator, Saglık Bilimleri UniversityDonmez Elif, Study director, Saglık Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647992
- Sponsor's protocol ID
- SaglikBilimleriU-ON-TO-01
- Status last verified
- Jun 2026
- First submitted
- 10 Oct 2024
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nurse Navigation Program on Cervical Cancer Screening Behaviour of the Women Aged 30-65
- ClinicalTrials.gov ID
- NCT06647992
- Acronym / sponsor ID
- SaglikBilimleriU-ON-TO-01
- Conditions
- Cervical Cancers
- Keywords
- Uterine Cervical Neoplasms, Patient Navigation, Transtheoretical Model, Health behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- TURKAN OZDASUniversity, hospital or other
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group- Nurse Navigation Program | Experimental | Behavioral: Nurse Navigation ProgramThe 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. |
| 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse Navigation ProgramIt 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. | Behavioural | Intervention group- Nurse Navigation Program |
Primary outcome
Health Belief Model Scale for Cervical Cancer and Pap Smear Test: Psychometric testing
Time frame: Pre-test, 3rd month post-test, 6th month post-test
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Turkan Ozdas principal investigator
Saglık Bilimleri University
Donmez Elif study director
Saglık Bilimleri University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse Navigation Program in people with Cervical Cancers, run by TURKAN OZDAS at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Belief Model Scale for Cervical Cancer and Pap Smear Test: Psychometric testing (time frame: Pre-test, 3rd month post-test, 6th month post-test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.