Cervical CancerNCT06177236
Clinic or Self-Sampling for Cervical Cancer Screening
A study testing cervical cancer screening in people with Cervical Cancer and HPV Infection, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. 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 Cancer, HPV Infection
- What is being tested?
- cervical cancer screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 1 Dec 2023
- 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
Inclusion Criteria: Must be able to perform self-test
Exclusion Criteria: pregnancy, diagnosing the cervix
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Unıversıty-Cerrahpasa
Istanbul, 34000
About this study
Official title: The Effect of in Clinic or Self- Sampling for Cervical Cancer Screening on Status of Particitipation, Attitude and Anxiety.
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.
Read the detailed description
Introduction: Persistent infection with high-risk HPV strains is the main cause of cervical cancer.
Objective: The aim of this study was to determine the effect of clinic or self-sampling on cervical cancer screening participation, attitudes and anxiety in women.
Method: The study was conducted as a descriptive and randomized controlled study between October 2022 and December 2023 in Ödemiş ASM No. 2, Ministry of Health, Republic of Turkey. The first phase of the study was conducted with 309 women and the "Introductory Information Form" and "Attitude Scale for Early Diagnosis of Cervical Cancer" were used to evaluate participation and attitudes towards cervical cancer screening. The second phase of the study was conducted as a randomized controlled trial with 110 women in the experimental (n=55) and control (n=55) groups. The women in the experimental group were trained before the procedure and were allowed to take samples from the vaginal area on their own. The women in the control group were sampled from the cervical region by the clinician. Both groups were pretested before the procedure using the "Descriptive Information Form" and the "State Anxiety Inventory" to measure anxiety. After the sampling procedure, the post-test was administered to the experimental and control groups using the "State Anxiety Inventory".
Results: According to the screening method preferences of the women, 34% (n=105) preferred a self-test, 18.4% (n=57) preferred a test performed by a clinician in a clinic, 3.9% (n=12) preferred no method, and 43.7% (n=135) preferred both methods. In the study, it was found that the self-test option increased participation in screening. The mean total score of the women was found to be 102.896±5.660. This result shows that women have high positive attitudes towards early diagnosis of cervical cancer. In the second stage of the study, it was observed that the descriptive characteristics of the experimental and control groups showed homogeneous distribution. While there was no significant difference between the experimental and control groups in terms of anxiety level in the pretest, it was found that the control group had a significantly higher anxiety level in the posttest.
Conclusion: In this study, it was observed that women had positive attitudes towards cervical cancer screening, self-sampling increased participation in screening and decreased anxiety levels.
- Conditions
- Cervical Cancer, HPV Infection
- Being tested
- cervical cancer screening
- Keywords
- cervical cancer, HPV testing
- Medical subject headings
- Uterine Cervical Neoplasms, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical cancer screeningDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: cervical cancer screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
This result shows that women have high positive attitudes towards early diagnosis of cervical cancer.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start1 Oct 2022
- Primary completion1 Oct 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Health Institutes of Turkey
- Responsible party
- Principal investigator, OZGE SEN, Istanbul University - Cerrahpasa
- Investigators
- Özge Şen, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177236
- Sponsor's protocol ID
- stanbulUC
- Status last verified
- Dec 2023
- First submitted
- 22 Nov 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of in Clinic or Self- Sampling for Cervical Cancer Screening on Status of Particitipation, Attitude and Anxiety.
- ClinicalTrials.gov ID
- NCT06177236
- Acronym / sponsor ID
- stanbulUC
- Conditions
- Cervical Cancer, HPV Infection
- Keywords
- cervical cancer, HPV testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Health Institutes of Turkey
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 20 Dec 2023 (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.
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.
Detailed description
Introduction: Persistent infection with high-risk HPV strains is the main cause of cervical cancer.
Objective: The aim of this study was to determine the effect of clinic or self-sampling on cervical cancer screening participation, attitudes and anxiety in women.
Method: The study was conducted as a descriptive and randomized controlled study between October 2022 and December 2023 in Ödemiş ASM No. 2, Ministry of Health, Republic of Turkey. The first phase of the study was conducted with 309 women and the "Introductory Information Form" and "Attitude Scale for Early Diagnosis of Cervical Cancer" were used to evaluate participation and attitudes towards cervical cancer screening. The second phase of the study was conducted as a randomized controlled trial with 110 women in the experimental (n=55) and control (n=55) groups. The women in the experimental group were trained before the procedure and were allowed to take samples from the vaginal area on their own. The women in the control group were sampled from the cervical region by the clinician. Both groups were pretested before the procedure using the "Descriptive Information Form" and the "State Anxiety Inventory" to measure anxiety. After the sampling procedure, the post-test was administered to the experimental and control groups using the "State Anxiety Inventory".
Results: According to the screening method preferences of the women, 34% (n=105) preferred a self-test, 18.4% (n=57) preferred a test performed by a clinician in a clinic, 3.9% (n=12) preferred no method, and 43.7% (n=135) preferred both methods. In the study, it was found that the self-test option increased participation in screening. The mean total score of the women was found to be 102.896±5.660. This result shows that women have high positive attitudes towards early diagnosis of cervical cancer. In the second stage of the study, it was observed that the descriptive characteristics of the experimental and control groups showed homogeneous distribution. While there was no significant difference between the experimental and control groups in terms of anxiety level in the pretest, it was found that the control group had a significantly higher anxiety level in the posttest.
Conclusion: In this study, it was observed that women had positive attitudes towards cervical cancer screening, self-sampling increased participation in screening and decreased anxiety levels.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| randomıze | Experimental | Diagnostic Test: cervical cancer screeningAssuming 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 |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| cervical cancer screeningThe aim of this project was to determine the effect of clinic or self-sampling on attendance, attitudes, and anxiety in cervical cancer screening. | Diagnostic test | randomıze |
Primary outcome
The Effect of in Clinic or Self-Sampling for Cervical Cancer Screening on Status of Participation
Time frame: 1 year
In the study, it was found that the self-test option increased participation in screening.
1 secondary outcome
The Effect of in Clinic or Self-Sampling for Cervical Cancer Screening on Status of ling for Cervical Cancer Screening on Status of Attitude
Time frame: 1 year
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 20 Dec 2023.
- 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.
Özge Şen principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical cancer screening in people with Cervical Cancer and HPV Infection, run by Istanbul University - Cerrahpasa 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?
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 20 Dec 2023. 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?
The Effect of in Clinic or Self-Sampling for Cervical Cancer Screening on Status of Participation (time frame: 1 year). 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 20 Dec 2023.