Actively Recruiting
Assessment of Sexual Well-being in Patients With Gynecologic Cancer and Their Partners: the ONCOSEX Study
Led by Casa di Cura Dott. Pederzoli · Updated on 2026-04-29
200
Participants Needed
6
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This observational, exploratory, prospective, longitudinal, multicenter study aims to track changes in sexual function over time in patients diagnosed with gynecologic cancers and their partners, without altering their standard clinical care. The study focuses on understanding how sexual health and relationships are affected by these cancers, addressing a frequently overlooked aspect of patient well-being recognized by the World Health Organization as a fundamental right. It seeks to evaluate sexual function questionnaire scores and the perceived usefulness and timing of sexual counseling support. Participants include patients with various gynecological cancers and their partners. Patients complete the Female Sexual Function Index (FSFI) questionnaire and a detailed section on sexual experience, satisfaction, and difficulties. Male partners complete the International Index of Erectile Function (IIEF-15), while female partners complete the same assessments as patients. Questionnaires are administered at diagnosis (T0), six months after treatment starts (T1), and twelve months after treatment or surgery completion (T2). Sociodemographic, clinical, lifestyle, and relationship data are also collected. During the study, participants provide written informed consent and complete questionnaires at three key time points. Data are recorded with pseudonymized codes to protect privacy. Researchers will analyze changes in FSFI and IIEF-15 scores over time and assess how many participants find sexual counseling helpful and when they prefer it. The study expects to enroll 200 patients and 200 partners, with data collection and analysis continuing through follow-up visits over approximately a year after treatment.
CONDITIONS
Brief Title
Assessment of Sexual Well-being in Patients With Gynecologic Cancer and Their Partners: the ONCOSEX Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with gynecological cancer including malignant ovarian tumor, ovarian tumor of uncertain behavior, cervical cancer, endometrial cancer, uterine sarcoma, vulvar cancer, or vaginal cancer
- Sexually active
- Women who have a partner
- Aged between 18 and 75 years
- 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
You will not qualify if you...
- Benign gynecological conditions
- Age under 18 years or over 75 years
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 months
Participants complete questionnaires and physical exams to assess sexual well-being at diagnosis, 6 months after the start of therapy or surgery, and 12 months after treatment completion. Partners are assessed at the same time points.
3 visits (in-person or remote) over 12 months
Trial Site Locations
Total: 6 locations
1
IRCCS Azienda ospedaliero-universitaria di Bologna - Policlinico Sant'Orsola
Bologna, Bologna, Italy, 40138
Not Yet Recruiting
2
IEO - Istituto Europeo di Oncologia
Padova, Padova, Italy, 20141
Not Yet Recruiting
3
Policlinico Universitario Fondazione Agostino Gemelli
Roma, Roma, Italy, 0630151
Not Yet Recruiting
4
IRCCS Materno infantile Burlo Garofolo
Trieste, Trieste, Italy, 34137
Not Yet Recruiting
5
Presidio Ospedaliero Universitario "Santa Maria della Misericordia"
Udine, Udine, Italy, 33100
Not Yet Recruiting
6
Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
Peschiera del Garda, Verona, Italy, 37019
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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