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

NCT07557342 | Recruiting DMC

• 1 other identifier: 932CET
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 6

Brief 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. 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.

Conditions

Sexual Wellness; Gynecologic Cancers

Keywords

gynecologic cancers; sexuality; partner; cancer survivors

Outcome Measures

Primary Outcomes (1)

• Changes in FSFI questionnaire scores among female participants and IIEF scores among male participants across different assessment time points

  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

  6 months

Interventions

Questionnaire and Physical Exam OTHER

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Casa di Cura Dott. Pederzoli: lead

Study Sites (6)

IRCCS Azienda ospedaliero-universitaria di Bologna - Policlinico Sant'Orsola

Bologna, Bologna, 40138, Italy

NOT YET RECRUITING

IEO - Istituto Europeo di Oncologia

Padova, Padova, 20141, Italy

NOT YET RECRUITING

Policlinico Universitario Fondazione Agostino Gemelli

Roma, Roma, 0630151, Italy

NOT YET RECRUITING

IRCCS Materno infantile Burlo Garofolo

Trieste, Trieste, 34137, Italy

NOT YET RECRUITING

Presidio Ospedaliero Universitario "Santa Maria della Misericordia"

Udine, Udine, 33100, Italy

NOT YET RECRUITING

Ospedale P. Pederzoli Casa di Cura Privata S.p.A.

Peschiera del Garda, Verona, 37019, Italy

RECRUITING

MeSH Terms

Conditions

Sexuality

Interventions

Surveys and Questionnaires; Restraint, Physical

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 29, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (6)