Psychosexuological Interventions to Support Sexual Function in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Evaluation of differences between two arms in female sexual satisfaction and functionality scores
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Evaluation of differences between two arms in female sexual satisfaction and functionality scores
时间窗: 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.
次要结局
- Evaluation of differences between two arms in levels of sleep quality(10 weeks)
- Evaluation of differences between two arms in levels of anxiety and depression(10 weeks)
- Evaluation of differences between two arms in levels of quality of life(10 weeks)