Psychosexuological Interventions to Support Sexual Function in Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

Psychosexuological Interventions to Support Sexual Function in Breast Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06327607
• Other study ID #: IEO 1952
• Status: Recruiting
• Start date: June 9, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: European Institute of Oncology
• Contact: Gabriella Pravettoni
• Phone: +390257489731
• Email: gabriella.pravettoni[@]ieo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Control Group
Standard care for breast cancer
• Psychosexological 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.

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of differences between two arms in female sexual satisfaction and functionality scores	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.	10 weeks
Secondary	Evaluation of differences between two arms in levels of quality of life	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.	10 weeks
Secondary	Evaluation of differences between two arms in levels of anxiety and depression	Levels of anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS).	10 weeks
Secondary	Evaluation of differences between two arms in levels of sleep quality	Levels of sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI) questionnaire.	10 weeks