Clinical trial · Observational
Psychosexuological Interventions to Support Sexual Function in Breast Cancer Patients
NCT06327607CI-TRIAL-00075373unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prospective pilot study on the feasibility and efficacy of a brief psychosexual support intervention in breast cancer patients undergoing hormonal therapies for at least 6 months. The study is randomized in the two following arms: Control arm (standard care pathway) Psychosexual intervention arm
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control Group | Other | — | UNRESOLVED |
| Psychosexological intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Control group
- description
- Standard iter of treatment for breast cancer
- interventionNames
- Other: Control Group
- label
- Experimental group
- description
- Psychosexuological intervention
- interventionNames
- Other: Psychosexological intervention
Primary outcomes (1)
- measure
- Evaluation of differences between two arms in female sexual satisfaction and functionality scores
- timeFrame
- 10 weeks
- description
- Measurement of the differences between the two groups in female sexual satisfaction and functionality scores before and after participation in the psychosexual intervention group, we will use the Brief Index of Sexual Functioning-Woman (BISF-W). This is a self-administered questionnaire specifically designed to assess female sexual functionality and satisfaction.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.