Developing and Validating a Breast Cancer Screening Health Literacy Questionnaire Guided by Sørensen’s Integrated Model for Malaysian Adults
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Abstract
Background: Health literacy is essential for informed decision-making and cancer prevention. In Malaysia, limited health literacy contributes to delayed breast cancer diagnoses and poorer outcomes among disadvantaged populations. However, there is no validated instrument for assessing breast cancer screening health literacy. Accordingly, this study aimed to develop and validate such a questionnaire for Malaysian adults.
Methods: A three-phase, multi-method design was employed. Phase One involved item generation through a systematic review, online surveys, expert validation and translation. Phase Two included cognitive debriefing and an analysis of test–retest reliability. Phase Three consisted of a cross-sectional survey of 779 adults (mean age 36.6 years; 66% female) attending clinics in Selangor and Johor. The scale was evaluated psychometrically with exploratory factor analysis, internal consistency and confirmatory factor analysis using covariance-based structural equation modelling.
Results: The initial 66-item tool was refined to a questionnaire with 41 items in seven domains showing strong reliability (Cronbach’s α ≥ 0.93; corrected item–total correlations ≥ 0.71). Weighted kappa values indicated moderate to almost perfect agreement (> 0.41) for most items. Confirmatory factor analysis showed factor loadings of 0.75 to 0.92, average variance extracted > 0.50, composite reliability > 0.70, heterotrait–monotrait ratios < 0.90 and acceptable fit indices (χ²/df = 2.18, GFI = 0.85, AGFI = 0.83, CFI = 0.95, TLI = 0.95, RMSEA = 0.052).
Conclusion: The validated 41-item Breast Cancer Screening Health Literacy Questionnaire is a reliable and culturally appropriate tool in Bahasa Malaysia that can be employed in clinical and community settings to identify literacy gaps, develop tailored health promotion strategies and strengthen early detection initiatives.
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References
Berkman N, Sheridan S, Donahue K, Halpern D, Crotty K. Low health literacy and health outcomes: an updated systematic review. Ann Intern Med. 2011;155(2):97–107. https://doi.org/10.7326/0003-4819-155-2-201107190-00005
Sørensen K, Van den Broucke S, Fullam J, Doyle G, Pelikan J, Slonska Z, et al. Health literacy and public health: a systematic review and integration of definitions and models. BMC Public Health. 2012;12(1):80. https://doi.org/10.1186/1471-2458-12-80
Batterham RW, Hawkins M, Collins PA, Buchbinder R, Osborne RH. Health literacy: applying current concepts to improve health services and reduce health inequalities. Public Health. 2016;132:3–12. https://doi.org/10.1016/j.puhe.2016.01.001
Ministry of Health Malaysia. Malaysia National Cancer Registry Report (MNCR) 2012–2016. Putrajaya: National Cancer Institute; 2019.
Moey SF, Mutalib AMA, Mohamed NC, Saidin N. The relationship of socio-demographic characteristics and knowledge of breast cancer on stage of behavioral adoption of breast self-examination. AIMS Public Health. 2020;7(3):620–633. https://doi.org/10.3934/publichealth.2020049
Al-Naggar RA, Bobryshev YV, Al-Jashamy K. Practice of breast self-examination among women in Malaysia. Asian Pac J Cancer Prev. 2012;13(8):3829–3833. https://doi.org/10.7314/APJCP.2012.13.8.3829
Norsa’adah B, Rahmah MA, Rampal KG, Knight A. Understanding barriers to Malaysian women with breast cancer seeking help. Asian Pac J Cancer Prev. 2012;13(8):3723–3730. https://doi.org/10.7314/APJCP.2012.13.8.3723
Al-Naggar RA, Bobryshev YV. Practice and barriers of mammography among Malaysian women in the general population. Asian Pac J Cancer Prev. 2012;13(8):3595–3600. https://doi.org/10.7314/APJCP.2012.13.8.3595
Mohan D, Su TT, Donnelly M, Hoe WMK, Schliemann D, Tan MM, et al. Breast cancer screening in semi-rural Malaysia: utilisation and barriers. Int J Environ Res Public Health. 2021;18(23):12293. https://doi.org/10.3390/ijerph182312293
Dumenci L, Matsuyama R, Riddle DL, Cartwright LA, Perera RA, Chung H, et al. Measurement of cancer health literacy and identification of patients with limited cancer health literacy. J Health Commun. 2014;19(Suppl 2):205–224. https://doi.org/10.1080/10810730.2014.943377
van der Vaart R, Drossaert CHC, Taal E, ten Klooster PM, Hilderink-Koertshuis RTE, Klaase JM, et al. Validation of the Dutch functional, communicative and critical health literacy scales. Patient Educ Couns. 2012;89(1):82–88. https://doi.org/10.1016/j.pec.2012.07.014
Ishikawa H, Takeuchi T, Yano E. Measuring functional, communicative, and critical health literacy among diabetic patients. Diabetes Care. 2008;31(5):874–879. https://doi.org/10.2337/dc07-1932
Sørensen K, Pelikan J, Röthlin F, Ganahl K, Slonska Z, Doyle G, et al. Health literacy in Europe: comparative results of the European health literacy survey (HLS-EU). Eur J Public Health. 2015;25(6):1053–1058. https://doi.org/10.1093/eurpub/ckv043
McKenzie JE, Hetrick SE, Page MJ. Updated reporting guidance for systematic reviews: introducing PRISMA 2020 to readers of the Journal of Affective Disorders. J Affect Disord. 2021;292:56–57. https://doi.org/10.1016/j.jad.2021.05.035
Streiner DL, Norman GR, Cairney J. Health measurement scales: a practical guide to their development and use. 5th ed. Oxford: Oxford University Press; 2014. https://doi.org/10.1093/med/9780199685219.001.0001
Nanda T, Gupta H, Kharub M, Singh N. Diagnostics for pretesting questionnaires: a comparative analysis. Int J Technol Policy Manag. 2013;13(1):67–79. https://doi.org/10.1504/IJTPM.2013.051008
Bonett DG, Wright TA. Cronbach’s alpha reliability: interval estimation, hypothesis testing, and sample size planning. J Organ Behav. 2015;36(1):3–15. https://doi.org/10.1002/job.1960
Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977;33(1):159–174. https://doi.org/10.2307/2529310
Comrey AL, Lee HB. A first course in factor analysis. 2nd ed. New York: Psychology Press; 2013. https://doi.org/10.4324/9781315827506
Hair J, Black WC, Babin BJ, Anderson RE. Multivariate data analysis. 7th ed. Upper Saddle River (NJ): Pearson Prentice Hall; 2010.
Worthington R, Whittaker T. Scale development research: a content analysis and recommendations for best practices. Couns Psychol. 2006;34:806–838. https://doi.org/10.1177/0011000006288127
Mardia KV. Measures of multivariate skewness and kurtosis with applications. Biometrika. 1970;57(3):519–530. https://doi.org/10.1093/biomet/57.3.519
Tehseen S, Ramayah T, Sajilan S. Testing and controlling for common method variance: a review of available methods. J Manag Sci. 2017;4(2):142–168. https://doi.org/10.20547/jms.2014.1704202
Nunnally J, Bernstein IH. Psychometric theory. 3rd ed. New York: McGraw-Hill; 1994.
Yao SX, Ellithorpe ME, Ewoldsen DR, Boster FJ. Development and validation of the female gamer stereotypes scale. Psychol Pop Media. 2022;12(4):392–404. https://doi.org/10.1037/ppm0000430
Cortina JM. What is coefficient alpha? An examination of theory and applications. J Appl Psychol. 1993;78(1):98–104. https://doi.org/10.1037/0021-9010.78.1.98
Cristobal E, Flavian C, Guinalíu M. Perceived e-service quality (PeSQ): measurement validation and effects on consumer satisfaction and web site loyalty. Manag Serv Qual. 2007;17(3):317–340. https://doi.org/10.1108/09604520710744326
Zakuan N, Yusof S, Saman MZ, Shaharoun A. Confirmatory factor analysis of TQM practices in Malaysia and Thailand automotive industries. Int J Bus Manag. 2009;5(1):160–175. https://doi.org/10.5539/ijbm.v5n1p160
Dunn KS. Development and psychometric testing of a new geriatric spiritual well-being scale. Int J Older People Nurs. 2008;3(3):161–169. https://doi.org/10.1111/j.1748-3743.2007.00107.x
Awang Z, Wan Afthanorhan WMA, Lim SH, Zainudin NFS. SEM made simple 2.0: a gentle approach of structural equation modelling. Malaysia: Universiti Sultan Zainal Abidin; 2023. 184 p.
Ringle CM, Wende S, Becker JM. SmartPLS 4: discriminant validity assessment and heterotrait-monotrait ratio of correlations (HTMT) [Internet]. 2024 [Retrieved 2025 Jan 11]. Available at: https://www.smartpls.com/documentation/algorithms-and-techniques/discriminant-validity-assessment
McDonald F, Patterson P, Costa D, Shepherd H. Validation of a health literacy measure for adolescents and young adults diagnosed with cancer. J Adolesc Young Adult Oncol. 2015;5(1):69–75. https://doi.org/10.1089/jayao.2014.0043
Williams KP, Reckase M, Rivera-Vazquez O. Toward the development of cancer literacy assessment tools. Mich J Public Health. 2008;2(1):6.
Williams KP, Templin TN, Hines RD. Answering the call: a tool that measures functional breast cancer literacy. J Health Commun. 2013;18(11):1310–1325. https://doi.org/10.1080/10810730.2013.778367
Barros A, Santos H, Moreira L, Santos-Silva F. Translation and cross-cultural adaptation of the cancer health literacy test for Portuguese cancer patients: a pre-test. Int J Environ Res Public Health. 2022;19(10):6237. https://doi.org/10.3390/ijerph19106237
Shan Y, Ji M. The Chinese version of the breast cancer literacy assessment tool: translation, adaptation, and validation study. JMIR Form Res. 2023;7:e43002. https://doi.org/10.2196/43002
Han H‑R, Huh B, Kim MT, Kim J, Nguyen T. Development and validation of the assessment of health literacy in breast and cervical cancer screening. J Health Commun. 2014;19(Suppl 2):267–284. https://doi.org/10.1080/10810730.2014.936569
Gibbs HD, Ellerbeck EF, Befort C, Gajewski B, Kennett AR, Yu Q, et al. Measuring nutrition literacy in breast cancer patients: development of a novel instrument. J Cancer Educ. 2016;31(3):493–499. https://doi.org/10.1007/s13187-015-0851-y
Huang YJ, Lin GH, Lu WS, Tam KW, Chen C, Hou WH, et al. Validation of the European Health Literacy Survey Questionnaire in women with breast cancer. Cancer Nurs. 2018;41(2):E40–E48. https://doi.org/10.1097/NCC.0000000000000475
National Cancer Registry Department. Summary of the Malaysia National Cancer Registry Report 2017–2021. Putrajaya: Institut Kanser Negara, Ministry of Health Malaysia; 2021.
Mohd Said Z, Sutan R. Are we doing enough in promoting breast cancer screening: an evaluation of Malaysia breast cancer screening program. Malays J Public Health Med. 2021;21(3):230–239. https://doi.org/10.37268/mjphm/vol.21/no.3/art.1430
Htay MNN, Donnelly M, Schliemann D, Loh SY, Dahlui M, Somasundaram S, et al. Breast cancer screening in Malaysia: a policy review. Asian Pac J Cancer Prev. 2021;22(6):1685–1693. https://doi.org/10.31557/APJCP.2021.22.6.1685
Ministry of Health Malaysia. National Strategic Plan for Cancer Control Programme 2021–2025. Putrajaya: Non‑Communicable Disease Section (NCD), Disease Control Division; 2021. 174 p.
Htay MNN, Su TT, Donnelly M. Risk‑stratified breast cancer screening in Malaysia: challenges and opportunities. Asian Pac J Cancer Prev. 2024;25(3):785–791. https://doi.org/10.31557/APJCP.2024.25.3.785
Ghazi H, Abdalqader M, Baobaid M, Hasan T, Pillai P, Hassan MR, et al. Awareness and belief regarding breast cancer among women living in Selangor, Malaysia. Malays J Public Health Med. 2020;20(1):30–39. https://doi.org/10.37268/mjphm/vol.20/no.1/art.427
Rajaram N, Jaganathan M, Muniandy K, Rajoo Y, Zainal H, Rahim N, et al. Barriers to help‑seeking for Malaysian women with symptoms of breast cancer: a mixed‑methods, two‑step cluster analysis. BMC Health Serv Res. 2023;23(1):206. https://doi.org/10.1186/s12913-023-09046-x
Institute of Public Health. National Health and Morbidity Survey (NHMS) 2019: key findings. Selangor: Institute for Public Health, National Institutes of Health (NIH); 2020.
Poon PKM, Tam KW, Lam T, Luk AKC, Chu WCW, Cheung P, et al. Poor health literacy associated with stronger perceived barriers to breast cancer screening and overestimated breast cancer risk. Front Oncol. 2023;12:1053698. https://doi.org/10.3389/fonc.2022.1053698
Rastegar M, Mahmoodi Z, Esmaelzadeh Saeieh S, Sharifi N, Kabir K. The effect of health literacy counselling on self‑care in women after mastectomy: a randomized clinical trial. J Caring Sci. 2020;9(1):39–45. https://doi.org/10.34172/jcs.2020.007
Fatiregun OA, Kuyinu Y, Alabi A, Sowunmi A, Ndidi O, Abiodun PO, et al. Health literacy and breast cancer preventive practices among market women in Oshodi Local Government Area of Lagos State, Nigeria. Ecancermedicalscience. 2024;18:1785. https://doi.org/10.3332/ecancer.2024.1785