Adherence to the SAGER guidelines in psycho-oncology trials: a systematic review

Background

Sex and gender substantially shape psychosocial outcomes and supportive care needs among cancer patients. Their inadequate integration into clinical research compromises scientific validity and perpetuates inequities in cancer care. We systematically 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

We conducted a systematic review of RCTs published between 2020 and 2025 and indexed in PubMed, focusing on adult cancer patients receiving psycho-oncological interventions. Adherence to the SAGER guidelines was coded dichotomously at the item level and summarized using total scores, accounting for differences in item applicability between studies, including one versus multiple sexes or genders. Item-level frequencies and exploratory regression models were used to characterize reporting patterns and their correlates.

Results

Among 404 included trials, 55.2% half of studies (n = 223) used sex and gender terminology inaccurately. Among studies including multiple sexes or genders, the mean SAGER adherence score was 1.23 (SD 0.88) out of 13, with 98.3% (n = 397) fulfilling three items or fewer. Single sex or gender studies showed mean adherence score of 0.90 (SD 0.81) out of 3. Regression analyses indicated no association between reporting quality and publication year, sample size, or journal impact factor.

Conclusions

Sex and gender are not adequately integrated in psycho-oncology intervention research. These shortcomings reflect structural deficiencies rather than isolated study-level limitations and constitute a major barrier to equitable and generalizable supportive cancer care. Strengthening mandatory reporting standards, editorial enforcement, and targeted training is essential to advance sex- and gender-sensitive psycho-oncology research and to reduce inequities in psychosocial cancer care.

Key messages

• Sex and gender are not adequately integrated in psycho-oncology intervention research, reflecting structural deficiencies rather than isolated study-level limitations.

• Without the integration of sex and gender into clinical research, the provision of equitable and supportive cancer care is compromised.