Psychosexuological Interventions to Support Sexual Function in Breast Cancer Patients

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Control Group; Other: Psychosexological intervention

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

• Study Type: Observational
• Enrollment (Estimated): 82

Contacts and Locations

• Study Contact: Name: Gabriella Pravettoni; Phone Number: +390257489731; Email: gabriella.pravettoni@ieo.it

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • European Institute of Oncology
    • Contact: Gabriella Pravettoni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study is for women who have had breast cancer and are currently undergoing hormonal therapies.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group; Standard iter of treatment for breast cancer	Other: Control Group; Standard care for breast cancer
Experimental group; Psychosexuological intervention	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Gabriella Pravettoni, European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IEO 1952

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No