Psychosexuological Interventions to Support Sexual Function in Breast Cancer Patients
- Conditions
- Breast Cancer
- Interventions
- Other: Control GroupOther: Psychosexological intervention
- Registration Number
- NCT06327607
- Lead Sponsor
- European Institute of Oncology
- Brief Summary
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
- Detailed Description
The aim of the study is to evaluate the effectiveness of a psychosexual intervention on sexual functioning, mood (levels of depression and anxiety), sleep, and quality of life, compared to standard care pathway. Considering the high incidence of sexual dysfunction in breast cancer patients, this study will focus on this population of patients.
The psychosexual intervention aims to improve female sexual functionality and satisfaction by facilitating the understanding of disorders, enabling adequate assessment of possible interventions, and adopting specific treatment exercises.
Patients will be randomized in one of the following two arms:
Control arm (standard care pathway) Psychosexual intervention arm
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 82
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control group Control Group Standard iter of treatment for breast cancer Experimental group Psychosexological intervention Psychosexuological intervention
- Primary Outcome Measures
Name Time Method Evaluation of differences between two arms in female sexual satisfaction and functionality scores 10 weeks 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.
- Secondary Outcome Measures
Name Time Method Evaluation of differences between two arms in levels of sleep quality 10 weeks Levels of sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI) questionnaire.
Evaluation of differences between two arms in levels of anxiety and depression 10 weeks Levels of anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS).
Evaluation of differences between two arms in levels of quality of life 10 weeks To measure the differences between the two arms in levels of quality of life investigated using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire.
Trial Locations
- Locations (1)
European Institute of Oncology
🇮🇹Milan, Italy