- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07451340
Cross-Cultural Adaptation and Psychometric Validation of the Cervical Cancer Screening Uptake Questionnaire (CCSTQ) in Turkish Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cervical cancer remains an important public health issue affecting women's health. Cervical cancer screening plays a key role in reducing morbidity and mortality through early detection. Women's decisions to participate in screening are influenced not only by knowledge, but also by psychosocial factors such as social norms, perceived threat, perceived benefits and barriers, and self-efficacy. The Cervical Cancer Screening Uptake Questionnaire (CCSTQ) is a multidimensional instrument designed to assess psychological and social determinants that may influence women's participation in cervical cancer screening. The aim of this study is to translate and culturally adapt the CCSTQ into Turkish and to evaluate its psychometric properties among Turkish women.
This is a methodological study designed to translate, culturally adapt, and evaluate the psychometric properties of the CCSTQ in Turkish women. The study will be conducted in two phases: (1) translation and cross-cultural adaptation following international guidelines and recommendations; and (2) psychometric evaluation including factor structure, convergent validity, internal consistency, test-retest reliability, item discrimination, ceiling and floor effects, and known-groups validity. Women aged 21-65 years who meet the eligibility criteria and complete the Turkish version of the CCSTQ for psychometric evaluation. The study will end when the target sample size is reached and final assessments are completed.
Statistical analyses will be conducted using International Business Machines Statistical Package for the Social Sciences (IBM SPSS) Statistics.
- Continuous variables: mean ± standard deviation (SD) for normally distributed data; median and range for non-normally distributed data
- Categorical variables: number and percentage
- Normality assessment: Kolmogorov-Smirnov test and visual methods
- Exploratory Factor Analysis (EFA) for construct validity
- Intraclass Correlation Coefficient (ICC) for test-retest reliability
- Cronbach's alpha coefficient for internal consistency
- Significance level set at probability value (p) < 0.05
- Ceiling and floor effects defined as >15% concentration at the highest or lowest possible score.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Büşra Nur Erol, PhD
- Phone Number: +905444932720
- Email: icerbusra@gmail.com
Study Locations
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-
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Ankara, Turkey (Türkiye)
- Recruiting
- Not Applicable - Online Study
-
Contact:
- Büşra Nur Erol, PhD
- Phone Number: +905444932720
- Email: icerbusra@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Native Turkish speakers who can read and understand Turkish
- Aged between 21 and 65 years
- Able to communicate consciously and effectively
- Previously and/or currently sexually active
- Provide informed consent and agree to complete the Cervical Cancer Screening Uptake Questionnaire (CCSTQ)
- Voluntary female participants
Exclusion Criteria:
- History of total hysterectomy without cervical preservation
- Previous diagnosis of cervical cancer
- Severe mental illness or cognitive impairment
- Inability to complete the CCSTQ
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adult Turkish Women
Women aged 21-65 years who meet the eligibility criteria and complete the Turkish version of the Cervical Cancer Screening Uptake Questionnaire (CCSTQ) for psychometric evaluation.
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Participants will complete the Turkish version of the Cervical Cancer Screening Uptake Questionnaire (CCSTQ) and the Health Belief Model Scale for Cervical Cancer and the Pap Smear Test via an online survey for psychometric evaluation purposes.
No clinical intervention will be applied.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cervical Cancer Screening Uptake Questionnaire (CCSTQ)
Time Frame: Baseline and 2 weeks after the initial administration (Test-retest reliability )
|
The Cervical Cancer Screening Uptake Questionnaire (CCSTQ) is a 43-item, six-dimensional self-report instrument developed to assess cognitive, psychosocial, and structural determinants influencing women's participation in cervical cancer screening.
The scale covers social norms, knowledge and awareness, perceived threat, perceived benefits, perceived barriers, and self-efficacy.
It is rated on a five-point Likert scale and was developed based on the DOST model grounded in health behavior theory.
No clinically validated cut-off score has been established for the CCSTQ.
In the original study, the sample median was used to classify participants into high and low screening tendency groups.
The instrument is easy to administer and can be completed in a short time.
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Baseline and 2 weeks after the initial administration (Test-retest reliability )
|
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The Health Belief Model Scale for Cervical Cancer and the Pap Smear Test
Time Frame: At baseline
|
The Health Belief Model Scale for Cervical Cancer and the Pap Smear Test is a multidimensional instrument designed to evaluate health beliefs related to cervical cancer screening.
Originally developed within the framework of health belief theory and later adapted for cervical cancer and Pap smear screening, the scale consists of 35 items across five subdimensions: perceived benefits and motivation for Pap smear, perceived barriers to Pap smear, perceived seriousness of cervical cancer, perceived susceptibility, and health motivation.
The scale uses a five-point Likert response format, and each subscale is scored independently.
Higher scores indicate stronger perceptions or motivation within the respective domain, whereas higher perceived barriers are inversely associated with screening behavior.
Turkish version, validity and reliability study is available.
The scale will be used in this study to assess the convergent validity of the CCSTQ.
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At baseline
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Guvenc G, Akyuz A, Acikel CH. Health Belief Model Scale for Cervical Cancer and Pap Smear Test: psychometric testing. J Adv Nurs. 2011 Feb;67(2):428-37. doi: 10.1111/j.1365-2648.2010.05450.x. Epub 2010 Oct 15.
- Kyriazos, T.A., Applied psychometrics: sample size and sample power considerations in factor analysis (EFA, CFA) and SEM in general. Psychology, 2018. 9(08): p. 2207.
- Dsouza JP, Broucke SVD. DOST: A consolidated health behavior model that maps factors influencing cancer screening uptake. Arch Public Health. 2025 Mar 17;83(1):70. doi: 10.1186/s13690-025-01517-3.
- Champion, V.L. and C.S. Skinner, The health belief model. Health behavior and health education: Theory, research, and practice, 2008. 4: p. 45-65.
- Cheng N, Li X, Jin Z, Liu Y, Wang A. Cervical cancer screening uptake questionnaire (CCSTQ) for women: instrument development and validation. BMC Womens Health. 2025 Nov 26;25(1):577. doi: 10.1186/s12905-025-04065-8.
- World Health Organization, Global strategy to accelerate the elimination of cervical cancer as a public health problem. 2020: World Health Organization.
- Arbyn M, Weiderpass E, Bruni L, de Sanjose S, Saraiya M, Ferlay J, Bray F. Estimates of incidence and mortality of cervical cancer in 2018: a worldwide analysis. Lancet Glob Health. 2020 Feb;8(2):e191-e203. doi: 10.1016/S2214-109X(19)30482-6. Epub 2019 Dec 4. Erratum In: Lancet Glob Health. 2022 Jan;10(1):e41. doi: 10.1016/S2214-109X(21)00554-4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- E-79176220-050.04-2198580
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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