NCT04705038招募中不适用
A Feasibility Study of Orchiectomy in Patients With Prostate Cancer on Chronic LHRH Agonist or Antagonist Therapy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of patients that undergo orchiectomy after receiving study education intervention
研究概览
简要总结
The purpose of this study is to learn how an educational intervention about orchiectomy as an alternative to medical castration for those who are already on medical castration will impact the number of patients willing to undergo an orchiectomy (surgery to remove the testicles).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of metastatic prostatic adenocarcinoma
- •Receiving luteinizing hormone-releasing hormone (LHRH) agonist or LHRH antagonist therapy continuously for at least 1 year with anticipated lifelong therapy
- •Able to complete written surveys in English
排除标准
- •More than 2 prior systemic treatment regimens utilized in addition to castration.
研究组 & 干预措施
Educational Intervention
Experimental
Participants in this arm undergo a short educational session about orchiectomy. They will also be asked to complete questionnaires.
干预措施: Patient Education (Behavioral)
No Intervention
No Intervention
Participants that decline the education session will continue with routine care of their cancer.
They will also be asked to complete questionnaires.
结局指标
主要结局
Number of patients that undergo orchiectomy after receiving study education intervention
时间窗: 1 year
次要结局
- Number of patients that agree to participate in an educational session on surgical orchiectomy(1 year)
- Correlation of orchiectomy acceptance with race, socioeconomic status, level of education, and marital status.(1 year)
- Comparison of costs of medical versus surgical castration(1 year)
- Change in body image perception using the Hopwood BIS questionnaire in patients undergoing versus not undergoing orchiectomy.(1 year)
- Change in sexuality measured using the PROMIS v2.0 questionnaire in patients undergoing versus not undergoing orchiectomy.(1 year)
- Patient satisfaction with decision to under undergo orchiectomy as reported using the Regret Decision Scale.(1 year)
研究者
研究点 (1)
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