Development and Validation of a Breast Cancer Information Leaflet to Advance Health Literacy in Oncology: A Methodological Study
Year: 2026
Type: article
Abstract: Introduction: Breast cancer continues to be a significant global health concern, with increasing incidence rates, particularly in Asian populations. Providing patients with clear and reliable educational resources is essential for improving awareness and involvement in their care. Aim: To develop and validate a Patient Information Leaflet (PIL) for individuals with breast cancer to enhance their understanding of the disease, its treatment, and proper medication use. Materials and Methods: This methodological validation study was conducted at Department of Pharmacy Practice, KLE College of Pharmacy, KAHER, Belagavi Karnataka, India, and KLE Cancer hospital, Belagavi, over a period of four months from July 2025 to November 2025. The study followed a structured multi-phase process for the development and validation of the PIL, which was prepared using current oncology guidelines. A 10-item evaluation questionnaire was developed and reviewed by a multidisciplinary panel of experts, who rated each item on a 5-point Likert scale. Content validity was assessed using Item-level and Scale-level Content Validity Indices (I-CVI and S-CVI). The responses were analysed using Statistical Package for Social Sciences (IBM SPSS) version 20.0, with Cronbach’s alpha applied to assess internal consistency and readability indices used to evaluate the suitability of the leaflet for the target population. Results: A total of 60 experts participated in the validation. The PIL showed good internal consistency (Cronbach’s a=0.870). Content validity indicated strong expert agreement, with I-CVI values ranging from 0.81 to 0.96 and an S-CVI/Ave=0.91. Readability assessment yielded a Grade A rating (Flesch Reading Ease: 65.21; Flesch–Kincaid Grade Level: 5.53), indicating that the leaflet is clear, easy to understand, and appropriate for a broad audience. Conclusion: The validated leaflet serves as an effective and accessible educational tool for enhancing breast cancer awareness and supporting informed decision-making. Its high reliability and excellent readability make it suitable for clinical use as well as community health education. Further patientcentered evaluations are recommended to assess its impact on real-world understanding and health outcomes.
Language: English
Subfield: General Health Professions
Field: Health Professions
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $275
OpenAlex ID: W7166356987