UNDERSTANDING GENDER

The following gender factors, and in particular those related to psychosocial and behavioral determinants , were deeemed relevant as possible determinants of clinical outcome. Baseline characteristics: sex (Female, Male, Intersex, Transexual – Male to Female; Female to Male), personal sense of being (Woman, Man, Neutral, Other, Unknown or Not Reported), ethnicity/race, marital status, living arrangement, occupational status and type, level of education, income, smoking condition, alcohol consumption, levels of physical activity, obesity. During treatment: general eating habits (10 items questionnaire), mediterranean diet adherence (14-item questionnaire; Martínez-González MA et al PREDIMED Study Investigators. A 14-item Mediterranean diet assessment tool and obesity indexes among high-risk subjects: the PREDIMED trial. PLoS One. 2012;7(8):e43134), ECOG performance status, distress levels (NCCN Distress Thermometer, and 5-item questionnaire on problem list), health status (EQ-5D-5L 5-item questionnaire). The dietary questionnaires in particular are important as diet is a determinant of microbiota composition which, in turn, influences the adverse events occurrence. (Details on https://zenodo.org/record/4142787; CRF 02 – Registration and baseline; CRF 05 – Questionnaires distress and health; CRF 10 – Diet form).