Sexual WellnessONCOSEXNCT07557342
Assessment of Sexual Well-being in Patients With Gynecologic Cancer and Their Partners: the ONCOSEX Study
An observational study of Sexual Wellness and Gynecologic Cancers, run by Casa di Cura Dott. Pederzoli at 6 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sexual Wellness, Gynecologic Cancers
- What is being tested?
- Questionnaire and Physical Exam
- How many people
- 200 participants
- Where
- 6 sitesItaly
- Study dates
- Start not givento Apr 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients diagnosed with gynecological cancer will be enrolled, regardless of the type of treatment proposed (surgery, concurrent chemoradiotherapy alone, neoadjuvant chemotherapy), provided they meet the inclusion criteria, do not meet any exclusion criteria (see above), and give their informed and unconditional consent to participate in the study by signing the appropriate forms. A necessary condition is that the patient's partner also provides informed and unconditional consent to participate in the study by signing the appropriate forms and agrees to complete the questionnaires within the same timeframe as the patient.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Italy6 sites, 6 recruiting
- Not yet recruiting
IRCCS Azienda ospedaliero-universitaria di Bologna - Policlinico Sant'Orsola
Bologna, Bologna, 40138
- Not yet recruiting
IEO - Istituto Europeo di Oncologia
Padova, Padova, 20141
- Recruiting
Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
Peschiera del Garda, Verona, 37019
Daniele Mautone, MD, +39 0456444097, urc@ospedalepederzoli.it
- Not yet recruiting
Policlinico Universitario Fondazione Agostino Gemelli
Roma, Roma, 0630151
- Not yet recruiting
IRCCS Materno infantile Burlo Garofolo
Trieste, Trieste, 34137
- Not yet recruiting
Presidio Ospedaliero Universitario "Santa Maria della Misericordia"
Udine, Udine, 33100
About this study
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.
Read more
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.
- Conditions
- Sexual Wellness, Gynecologic Cancers
- Being tested
- Questionnaire and Physical Exam
- Keywords
- gynecologic cancers, sexuality, partner, cancer survivors
- Medical subject headings
- Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Physical ExamOther
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 questionnaire administered to patients includes the Female Sexual Function Index (FSFI) and a section of structured questions investigating sexual experience, satisfaction, and difficulties. Partners are also enrolled and assessed at the same time points; the International Index of Erectile Function (IIEF-15) is used for male partners, while the same assessment tools used for patients are administered to female partners.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in FSFI questionnaire scores among female participants and IIEF scores among male participants across different assessment time points
Measured: 6 months
Secondary outcomes (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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Primary completionOct 2026 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual WellnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Casa di Cura Dott. Pederzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557342
- Sponsor's protocol ID
- 932CET
- Acronym
- ONCOSEX
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No