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

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.

Study Overview

• Status: Recruiting
• Conditions: Gynecologic Cancers; Sexual Wellness
• Intervention / Treatment: Other: Questionnaire and Physical Exam

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Italy
  • Bologna
    • Bologna, Bologna, Italy, 40138
      • Not yet recruiting
      • IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant'Orsola
  • Padova
    • Padova, Padova, Italy, 20141
      • Not yet recruiting
      • IEO - Istituto Europeo di Oncologia
  • Roma
    • Roma, Roma, Italy, 0630151
      • Not yet recruiting
      • Policlinico Universitario Fondazione Agostino Gemelli
  • Trieste
    • Trieste, Trieste, Italy, 34137
      • Not yet recruiting
      • IRCCS Materno Infantile Burlo Garofolo
  • Udine
    • Udine, Udine, Italy, 33100
      • Not yet recruiting
      • Presidio Ospedaliero Universitario "Santa Maria della Misericordia"
  • Verona
    • Peschiera del Garda, Verona, Italy, 37019
      • Recruiting
      • Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
      • Contact: Daniele Mautone, MD; Phone Number: +39 0456444097; Email: urc@ospedalepederzoli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in FSFI questionnaire scores among female participants and IIEF scores among male participants across different assessment time points	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Casa di Cura Dott. Pederzoli

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: April 22, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: gynecologic cancers; sexuality; cancer survivors; partner
• Additional Relevant MeSH Terms: Behavior; Sexual Behavior; Sexuality; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Therapeutics; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Behavior Control; Immobilization; Surveys and Questionnaires; Restraint, Physical
• Other Study ID Numbers: 932CET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No