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Scoping review protocol of person- and patient-centred outcomes in cancer clinical trials: definitions and
Miguel Zambrano Lucio1, Nirmala Bhoo-Pathy2, Sonia Menon3
1Unidad de Epidemiología, Instituto Nacional de Cancerología, Mexico City, Ciudad de México, Mexico.
Introduction:
Traditional oncology outcome measures, such as survival rates and disease progression, fail to fully capture the complex lived experiences of persons and patients with cancer, including psychological distress, financial burdens and changes in social roles. While person- and patient-centred outcomes have emerged as essential components of quality cancer care, ambiguities persist regarding their definitions and measurement methodologies in clinical trials.
Methods And Analysis:
This scoping review aims to explore how person-centred and patient-centred outcomes are defined and measured in cancer clinical trials and to identify trends, gaps and methodological approaches for their assessment. Comprehensive searches will be conducted across PubMed, SCOPUS, Sci-Elo, EMBASE, PsycINFO and Google Scholar for grey literature sources, encompassing articles from August 2020 to August 2025. Eligible studies include primary research that reports patient- or person-centred outcomes in cancer clinical trials. Studies focusing solely on preventative care or lacking assessment of patient- or person-centred outcomes will be excluded. Studies will be independently screened and selected by two reviewers in duplicate, adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. Data extraction will also be conducted independently and in duplicate using a standardised extraction tool, with disagreements resolved through consensus to ensure consistency and accuracy. Results will be synthesised qualitatively and quantitatively, with narrative and thematic analysis used to identify trends and gaps in the literature.
Ethics And Dissemination:
Ethical approval is not required. Results will be published in a peer-reviewed journal and presented at conferences.
Trial Registration Number:
https://doi.org/10.17605/OSF.IO/EYZPK.
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