What this Trial Is About

Study type and design This is an observational, exploratory, prospective, longitudinal (cohort), multicenter, non-profit study. Its purpose is to observe changes in sexual function over time without modifying standard clinical care pathways. Background and rationale Sexual dysfunctions and the psychological impact of gynecological cancers are often underestimated in clinical practice, despite the World Health Organization recognizing sexual health as a fundamental right. Cultural, personal, and educational barriers frequently hinder an open and systematic discussion of sexual health. Available literature highlights a significant deterioration in sexual quality of life and couple relationships among these patients; however, clear guidance on validated assessment tools and structured sexual counseling pathways is still lacking. Study objectives Primary objective: to evaluate whether and how sexual function questionnaire scores in patients and their partners change over time at different assessment time points. Secondary objective: to identify the proportion of patients and partners who would perceive sexual counseling as useful, as well as the preferred timing for such support. Endpoints Primary endpoint: variation in Female Sexual Function Index (FSFI) scores in female patients and International Index of Erectile Function (IIEF-15) scores in male partners between assessment time points (T0-T1, T1-T2, T0-T2). Secondary endpoint: perceived usefulness of sexual counseling support and preferred timing, based on questionnaire responses. Procedures and assessment timeline Patients are enrolled at the time of diagnosis communication (T0). The same questionnaire is administered again six months after the start of treatment (T1) and twelve months after completion of therapy or surgery (T2). Participation requires written informed consent, and all data are collected in a pseudo-anonymized format. Partners are enrolled and assessed at the same time points. Assessment tools Patients: the validated Female Sexual Function Index (FSFI) questionnaire, plus an additional structured section exploring sexual experience, satisfaction, and difficulties. Partners: the IIEF-15 questionnaire for male partners; for female partners, the same instruments used for patients are administered. Collected variables Sociodemographic and clinical data, lifestyle habits, sleep quality, marital status, parity, ongoing or previous therapies, and FSFI and IIEF-15 questionnaire scores. Sample size A total of 200 patients and 200 corresponding partners are expected to be enrolled. Statistical analysis Data will be analyzed descriptively and longitudinally across the three time points. The primary analysis will use linear mixed-effects models for repeated measures, including random effects for subjects and fixed effects for time and relevant clinical covariates. Predefined subgroup analyses are planned. Statistical significance is set at p \< 0.05.

Assessment of Sexual Well-being in Patients With Gynecologic Cancer and Their Partners: the ONCOSEX Study