NCT06327607

Psychosexuological Interventions to Support Sexual Function in Breast Cancer Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 82 (estimated)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	Control Group	Standard care for breast cancer
OTHER	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.

Timeline

• Start date: 2023-06-09
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-03-25
• Last updated: 2024-03-25

Locations

1 site across 1 country: Italy