Psychosexuological Interventions to Support Sexual Function in Breast Cancer Patients

European Institute of Oncology

Status

Enrolling

Conditions

Breast Cancer

Treatments

Other: Control Group

Other: Psychosexological intervention

Study type

Observational

Funder types

Other

Identifiers

NCT06327607

IEO 1952

Details and patient eligibility

About

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

Full 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

Enrollment

82 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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