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

Обзор

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.

Вмешательства

• Другое Questionnaire and Physical Exam
  Patients are enrolled at the time the diagnosis is communicated (T0). The questionnaire is administered again 6 months after the start of therapy or surgery (T1) and 12 months after completion of treatments or surgery (T2). Anamnestic and sociodemographic data of both the patient and the partner are recorded in the Case Report Form and entered into a dedicated database using a pseudo-anonymized identification code held exclusively by the Principal Investigator at the reference center. The questi

Первичные конечные точки

• Changes in FSFI questionnaire scores among female participants and IIEF scores among male participants across different assessment time points [Срок оценки: 6 months]

Вторичные конечные точки (1)

• the percentage of patients and partners who report perceiving the sex therapy support as beneficial, and their preferred timing for its initiation, based on questionnaire responses [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Patients diagnosed with gynecological cancer: malignant ovarian tumor, ovarian tumor of uncertain behavior, cervical cancer, endometrial cancer, uterine sarcoma, vulvar cancer, vaginal cancer
• Sexually active
• Women who have a partner
• Aged between 18 and 75
• Women of any sexual orientation
• Understanding and knowledge of the Italian language
• Signing of the informed consent form
• Signing of the informed consent form by the partner

Критерии исключения

• Benign gynecological conditions
• Age < 18 or > 75
• Virgins or women who are no longer sexually active
• Women with psychiatric or neurological disorders
• Women or partners who have already undergone sexual counseling or sex therapy
• Women who are unable to sign the informed consent form for the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 6 центров

• IRCCS Azienda ospedaliero-universitaria di Bologna - Policlinico Sant'Orsola — Bologna
• IEO - Istituto Europeo di Oncologia — Padova
• Policlinico Universitario Fondazione Agostino Gemelli — Roma
• IRCCS Materno infantile Burlo Garofolo — Trieste
• Presidio Ospedaliero Universitario "Santa Maria della Misericordia" — Udine
• Ospedale P. Pederzoli Casa di Cura Privata S.p.A. — Peschiera del Garda

Идентификаторы

NCT: NCT07557342 · 932CET

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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