Quality of sex and gender reporting in psycho-oncology trials: a systematic review

Abstract Background Rigorous integration of sex and gender is essential to ensure equitable outcomes in psycho-oncological interventions. This study assessed the quality of sex and gender reporting in randomized controlled trials (RCTs) of psycho-oncology interventions using the Sex and Gender Equity in Research (SAGER) guidelines. Methods A systematic review of RCTs of psycho-oncology interventions indexed in PubMed and published between 2020 and 2025 was conducted. Adherence to the SAGER guidelines was coded dichotomously at the item level and summarized using total scores. Item-level frequencies, analyses by tumor entity, and exploratory regression models were used to characterize reporting patterns and their correlates. Results Of the 404 trials included, more than half (55.2%, n = 223) failed to use sex and gender terminology correctly. In studies including multiple sexes or genders, the mean SAGER adherence score was 1.23 ( SD 0.88) out of 13. In studies including only one sex or gender, the mean adherence score was 0.90 ( SD 0.81) out of 3. Reporting deficiencies were consistent across tumor entities. Regression analyses indicated no association between SAGER adherence score and publication year, sample size, or journal impact factor. Conclusion Sex and gender are not systematically integrated into psycho-oncology intervention research. These shortcomings reflect structural deficiencies rather than isolated study-level limitations, reducing the interpretability and practical usability of psycho-oncology evidence for diverse patient populations. Strengthening mandatory reporting standards, editorial enforcement, and targeted training is essential to support more transparent, clinically relevant, and equitable psycho-oncology research and care.