Support for sexual function in breast cancer patients
Psychosexuological Interventions to Support Sexual Function in Breast Cancer Patients
This study is testing a new support program to help women with breast cancer improve their sexual function and overall well-being while they are on hormonal therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 82 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | European Institute of Oncology Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06327607 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the feasibility and effectiveness of a brief psychosexual support intervention for women with breast cancer who have been undergoing hormonal therapies for at least six months. Participants will be randomized into two groups: one receiving standard care and the other receiving the psychosexual intervention aimed at improving sexual functioning, mood, sleep, and quality of life. The intervention focuses on understanding sexual dysfunction and implementing specific treatment exercises to enhance sexual satisfaction. The study aims to address the high incidence of sexual dysfunction in this patient population.
Who should consider this trial
Good fit: Ideal candidates are pre-menopausal women aged 18 and older with breast cancer who have been on hormonal therapy for at least six months and exhibit signs of sexual dysfunction.
Not a fit: Patients who are postmenopausal or have psychiatric or neurological conditions that impair their ability to participate in the intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve sexual function and overall quality of life for breast cancer patients undergoing hormonal therapy.
How similar studies have performed: While there is limited data on similar psychosexual interventions specifically for breast cancer patients, existing studies suggest that addressing sexual dysfunction can lead to improved patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women with age \>=18 years; * Breast cancer patients undergoing hormonal therapy for at least 6 months in accordance with clinical practice and scientific evidence; * Pre-menopausal patients (regular menstrual cycles in the last year) before the start of oncological treatments; * Presence of one or more criteria of sexual dysfunction as per DSM-5; * Acceptance and signature of the Informed Consent. Exclusion Criteria: * Patients in postmenopausal status; * Presence of psychiatric or neurological conditions that impair the ability to perform the exercises proposed by the research project; * Already undergoing psycho-sexual counseling; * Refusal to sign the informed consent
Where this trial is running
Milan
- European Institute of Oncology — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Gabriella Pravettoni — European Institute of Oncology
- Study coordinator: Gabriella Pravettoni
- Email: gabriella.pravettoni@ieo.it
- Phone: +390257489731
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.