前列腺癌术后患者的长期随访
前列腺癌后的长期随访
This clinical trial studies how well a long-term follow-up works in patients with prostate cancer after surgery. Long-term follow-up data may serve as a resource to help ask clinical questions, describe health-related quality of life and long-term complications related, and facilitate future studies focusing on interventions to improve health status and health-related quality of life in prostate cancer survivors.
研究概览
地位
详细说明
PRIMARY OBJECTIVES:
I. To provide comprehensive long-term follow-up care to prostate cancer survivors at the City of Hope who underwent definitive surgical therapy.
II. To use the information obtained from follow-up of prostate cancer survivors who underwent definitive surgical therapy to serve as a resource that will help answer clinical questions, generate and test hypotheses, describe the incidence of long-term complications, and facilitate future studies focusing on interventions for long-term complications of prostate cancer and its therapy.
III. To use the information gained from follow-up of prostate cancer survivors who underwent definitive surgical therapy to describe health-related quality of life (HRQL) concerns and to serve as a resource to facilitate future studies focusing on interventions to improve health status and HRQL in prostate cancer survivors.
OUTLINE:
Patients undergo long-term follow-up and receive a written survivorship care plan including comprehensive health evaluation and health education beginning 1 year post surgery.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
California
-
Duarte、California、美国、91010
- City of Hope Medical Center
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
-
Diagnosis of prostate cancer
-
Treated with a definitive surgical procedure at City of Hope
-
At least one year post surgical treatment for prostate cancer
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No history of recurrent, progressive, or metastatic disease
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Currently stable disease or no evidence of disease
-
No prior treatment of prostate cancer with radiation or chemotherapy
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No history of other urologic cancer (e.g., bladder cancer, renal cell carcinoma) in addition to prostate cancer
- Note: Patients who develop recurrence while participating in the Prostate Cancer Survivorship Clinic will be referred back to their urologist and may resume participation in the Survivorship Clinic when deemed appropriate by their treating physician
Exclusion Criteria:
- Current treatment with testosterone replacement or androgen deprivation therapy
- Treatment for another noncutaneous cancer within the past 2 years
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Supportive Care (long-term follow-up)
Patients undergo long-term follow-up and receive a written survivorship care plan including comprehensive health evaluation and health education beginning 1 year post surgery. |
Correlative studies Ancillary studies
其他名称：
Ancillary studies Receive health education
其他名称：
Undergo long-term follow-up using survivorship care plan |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
HRQL assessed using Expanded Prostate Cancer Index Composite
大体时间：Up to 10 years
|
Linear mixed effects models can be used to estimate long-term trends and examine the effects of baseline and concomitant factors on these trends. |
Up to 10 years
|
|
HRQL assessed using Sexual Health Inventory for Men
大体时间：Up to 10 years
|
Linear mixed effects models can be used to estimate long-term trends and examine the effects of baseline and concomitant factors on these trends. |
Up to 10 years
|
|
Incidence rates of the study end-points
大体时间：Up to 10 years
|
Incidence rates of the study end-points that may be associated with original diagnosis or treatment received, and delineation of temporal changes in serial measurements and their relationship to time-invariant characteristics such as original diagnosis, race, and education and time-varying characteristics such as age and body mass index will be estimated. Incidence rates may be compared with national standards adjusted for key demographic variables and between patient subgroups. |
Up to 10 years
|
合作者和调查者
调查人员
- 首席研究员：Saro Armenian, DO、City of Hope Medical Center
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.