Perception About Benefits and Risks Related to Combined Hormonal Contraceptives Use in Patients With Lynch Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Number of patients using currently CHCs
研究概览
简要总结
Combined hormonal contraceptives (CHCs), according to the opinion by The Manchester International Consensus Group, should be considered for women wishing contraception because also positively impact endometrial cancer and ovarian cancer risk. The awareness of the effects of hormonal therapies in women at high risk of developing endometrial cancer, colorectal, breast, or ovarian cancer, such as those affected by Lynch syndrome (LS), is currently limited, with few published studies addressing these populations. Making informed decisions about CHC use in this context necessitates careful consideration of individual cancer risk and the potential benefits and risks associated with CHC use. Accurate information regarding the oncological risks associated with CHC use is essential for facilitating shared decision-making between women and their healthcare providers in this patient population.
This prospective study aims to evaluate the knowledge, attitudes, and beliefs of women with LS concerning CHCs and their potential effects on specific disease development and cancer risk, comparing them to the general population. By considering psychosocial factors and individual perceptions of cancer risk, this study seeks to contribute to informed decision-making, personalized counseling, and improved strategies for gynecologic cancer risk management in women with LS.
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 52 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •patients with certain genetic diagnosis of Lynch syndrome and patients of reproductive age undergoing routinely gynecological visit
排除标准
- •for both groups, a prior history of oncological diseases and a personal history of endometrial cancer, colorectal cancer, ovarian cancer, or breast cancer.
- •for patients with Lynch syndrome, individuals who had undergone previous risk-reducing prophylactic surgical approaches such as (risk-reducing) colectomy, hysterectomy, early salpingectomy, and delayed oophorectomy, and risk-reducing salpingo-oophorectomy
结局指标
主要结局
Number of patients using currently CHCs
时间窗: Through study completion, an average of 1 month
Evaluation of the number (%) of patients using currently CHCs
Perception about the impact of CHCs on favoring/contrasting specific cancer onset
时间窗: Through study completion, an average of 1 month
By using a Likert scale (from -5 to +5)
Perception about the impact of CHCs on favoring/contrasting specific chronic disease onset
时间窗: Through study completion, an average of 1 month
By using a Likert scale (from -5 to +5)
Perception about the impact of CHCs on favoring/contrasting specific symptoms onset
时间窗: Through study completion, an average of 1 month
By using a Likert scale (from -5 to +5)
Number of patients having used CHCs
时间窗: Through study completion, an average of 1 month
Evaluation of the number (%) of patients having used CHCs in the past
次要结局
未报告次要终点
研究者
Simone Ferrero
principal investigator
Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
