Breast Cancer
Conditions
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
Interventions
OTHERControl Group
Standard care for breast cancer
OTHERPsychosexological intervention
The intervention will be conducted individually and will take place once a week for one hour, for a total of 8 consecutive weeks, which must be completed within a maximum duration of 10 weeks.
Sponsors
European Institute of Oncology
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 sleep quality | 10 weeks | Levels of sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI) questionnaire. |
Countries
Italy
Contacts
Primary ContactGabriella Pravettoni
Outcome results
None listed