In common feeling, sex and gender represent the same concept, that is the traditional division of individuals into females (F) and males (M) defined by differential organization of chromosomes, reproductive organs, and sex steroid levels. However, if we go beyond these aspects, which characterize “sex”, we can see how the differences between people are also characterized by behaviors and relationships that are the product of the culture and sociality typical of human beings. This is what is called “gender”, i.e. the process of social and cultural construction that determines the behaviors that give life to the status of an individual. Gender is therefore learned and not innate. Sex and gender do not constitute two opposing but dentdimensions: the process of determining gender identity is triggered on biological characters. The relationship between sex and gender varies according to geographical areas, historical periods and cultures.

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).

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 741874. More information on the http://gender-net-plus.eu/ The contents of this website and the view expressed in the news and publications are the sole responsibility of the authors and under no circumstances can be regarded as reflecting the position of the European Union.
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