An observational study in Sexual Wellness and Gynecologic Cancers, sponsored by Casa di Cura Dott. Pederzoli. Recruiting at 6 sites in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Casa di Cura Dott. Pederzoli · Observational
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.
130 studies on the registry are indexed under Sexuality; 26 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 47 observational studies indexed under Sexuality.
Browse Sexuality studies →Casa di Cura Dott. Pederzoli is the lead sponsor of 15 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Changes in FSFI questionnaire scores among female participants and IIEF scores among male participants across different assessment time points
Time frame: 6 months
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
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Casa di Cura Dott. Pederzoli