Sexual well-being in people treated for gynecologic cancer and their partners
Assessment of Sexual Well-being in Patients With Gynecologic Cancer and Their Partners: the ONCOSEX Study
Casa di Cura Dott. Pederzoli · NCT07557342
This project will follow people with gynecologic cancer and their partners to see if their sexual function changes over time using questionnaires and brief exams.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Casa di Cura Dott. Pederzoli (other) |
| Locations | 6 sites (Bologna, Bologna and 5 other locations) |
| Trial ID | NCT07557342 on ClinicalTrials.gov |
What this trial studies
This is a prospective, longitudinal, multicenter observational cohort that follows sexually active patients with gynecologic cancers and their partners without changing standard clinical care. Participants complete validated sexual function questionnaires and undergo brief physical exams at multiple time points to document changes over time. The study is exploratory and non‑profit, aiming to include several Italian centers to capture a diverse patient population. Data collection focuses on patient- and partner-reported outcomes to better characterize couple dynamics and sexual quality of life after cancer.
Who should consider this trial
Good fit: Sexually active women aged 18–75 diagnosed with a malignant gynecologic tumor who have a partner, can speak Italian, and are willing to have their partner enroll and sign consent.
Not a fit: Women who are not sexually active, are under 18 or over 75, have benign gynecologic conditions, or who already received sexual counseling are unlikely to benefit from the observational findings.
Why it matters
Potential benefit: If successful, the findings could clarify common patterns of sexual dysfunction after gynecologic cancer and inform the design of targeted counseling and support pathways.
How similar studies have performed: Previous observational work has documented declines in sexual quality of life after gynecologic cancer, but few multicenter longitudinal cohorts that include partners and inform structured counseling pathways have been published.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Bologna, Bologna and 5 other locations
- IRCCS Azienda ospedaliero-universitaria di Bologna - Policlinico Sant'Orsola — Bologna, Bologna, Italy (NOT_YET_RECRUITING)
- IEO - Istituto Europeo di Oncologia — Padova, Padova, Italy (NOT_YET_RECRUITING)
- Policlinico Universitario Fondazione Agostino Gemelli — Roma, Roma, Italy (NOT_YET_RECRUITING)
- IRCCS Materno infantile Burlo Garofolo — Trieste, Trieste, Italy (NOT_YET_RECRUITING)
- Presidio Ospedaliero Universitario "Santa Maria della Misericordia" — Udine, Udine, Italy (NOT_YET_RECRUITING)
- Ospedale P. Pederzoli Casa di Cura Privata S.p.A. — Peschiera del Garda, Verona, Italy (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sexual Wellness, Gynecologic Cancers, gynecologic cancers, sexuality, partner, cancer survivors