NCT06458764招募中不适用
SEXCHECK - Sexual Dysfunction Check-up in Premenopausal Breast Cancer Survivors Taking Endocrine Therapy: A Cross-Sectional Study
Candiolo Cancer Institute - IRCCS1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Sexual Dysfunction (SD) incidence
研究概览
简要总结
Primary objectives:
- To estimate Sexual Dysfunction (SD) incidence in premenopausal breast cancer patients treated by surgery and taking endocrine therapy.
- To detect the presence of SD-related distress in the population, as a determining factor in the maintenance of a good quality of life.
Secondary objectives:
- To describe SD characteristics determining the most frequently reported symptoms and correlations with type of surgery or therapeutic regimens.
- Collect baseline data for subsequent randomized trials involving practical interventions with the aim to reduce SD prevalence in this population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women aged ≥18 and ≤ 55
- •who underwent surgery for early stage breast cancer
- •taking endocrine therapy for at least 3 months
- •providing an informed consent and completing the study questionnaires.
排除标准
- •withdrawal of the informed consent, at any time
结局指标
主要结局
Sexual Dysfunction (SD) incidence
时间窗: 6 months
To estimate Sexual Dysfunction (SD) incidence (physiological parameter) in premenopausal breast cancer patients treated by surgery and taking endocrine therapy.
SD-related distress
时间窗: 6 months
To detect the presence of SD-related distress (physiological parameter) in the population, as a determining factor in the maintenance of a good quality of life.
次要结局
- SD characteristics(6 months)
- Collect baseline data(6 months)
研究者
Giada Pozzi
MD
Candiolo Cancer Institute - IRCCS
研究点 (1)
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终止
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