Protocol for exploring health promoter-led mental wellness initiatives for early prevention, screening and quality of life in patients with cervical cancer of rural Eastern Cape, South Africa: a mixed-methods study

探索由健康促进员主导的心理健康举措在南非东开普省农村地区宫颈癌早期预防、筛查和患者生活质量提升方面的方案:一项混合方法研究

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Abstract

INTRODUCTION: Cervical cancer is in the top five list of highly prevalent cancers. It contributes to millions of premature deaths globally. Low- and middle-income countries like those in sub-Saharan Africa are among the worst affected despite the preventable nature of the disease. The disease is caused by the human papillomavirus, a sexually transmitted infection for which an effective vaccine exists. This study aims to determine the effectiveness of a health promoter-led intervention on early screening, prevention and quality-of-life improvement among patients with cervical cancer. METHODS AND ANALYSIS: The study will be conducted in South Africa's Eastern Cape province. The study will employ an exploratory sequential mixed-methods design, comprising four qualitative and quantitative substudies. For qualitative substudies, purposive sampling will select 20 cervical patients, and two to four focus group discussions will be conducted with health workers in the oncology units of two referral hospitals. Patients with a cervical cancer diagnosis will consent to participate in a survey on their quality of life and their mental health status, specifically screening for depression and anxiety. An equal number of patients (64) will be allocated to the two quantitative study arms. For substudies 1 and 2, in-depth interviews and focus group discussions will be conducted using a semistructured interview guide. The data will be audio recorded, transcribed verbatim and entered into NVivo V.15 for data analysis. For substudies 3 and 4, data will be collected using validated tools such as the WHO-Quality of Life tool to assess the quality of life of cervical cancer survivors, the Generalized Anxiety Disorder version 7 scale and the Patient Health Questionnaire version 9 for anxiety and depression. Data will be captured in Microsoft Excel and exported to SPSS V.29 software (Statistical Package for the Social Sciences). The study will use descriptive analyses of intervention participants' responses using means, SDs, medians and IQRs, depending on the normality of the distribution. ETHICS AND DISSEMINATION: The ethical clearance (protocol reference number: WSU HREC 023/2025) was approved by the Walter Sisulu University, Faculty of Medicine and Health Sciences, Ethics and Biosafety Committee, and access approval (reference number: EC_202503_022) was granted by the Eastern Cape Provincial Health Research Committee. TRIAL REGISTRATION NUMBER: PACTR202507608317068.

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