Energy Balance for Prostate Cancer Survivorship
2016年9月6日 更新者：Jill Hamilton-Reeves, PhD RD LD
The purpose of this study is to evaluate the effectiveness of a weight management program for men undergoing a prostatectomy by seeing if the program is easy to follow, impacts weight gain, and reduces risk of cancer recurrence in the participants.
研究概览
详细说明
The weight management program is designed to help participants lose weight before their prostatectomy and to help them maintain that weight loss after surgery. There are four main components to the weight management program. The four components of the program are:
- Diet
- Physical activity
- Coaching
- Diet and exercise monitoring tool
The program will be tailored to each individual participant. All participants will be ask to monitor their program using a tool provided by the study team. Participants will be actively participating in the study activities for about 5 months. After that, the study team will review medical records for up to 10 years after enrollment to monitor weight changes and cancer status.
研究类型
介入性
注册 (实际的)
20
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Kansas
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Kansas City、Kansas、美国、66160
- University of Kansas Medical Center
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 至 72年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
男性
描述
Inclusion Criteria:
- Men newly diagnosed with prostate cancer who are scheduled for prostatectomy (Stage T1 or T2)
- Body Mass Index (BMI) 25-45 kg/m2
- Have internet access
- Have an iPad/iPhone/iDevice
Exclusion Criteria:
- History of 5 alpha reductase inhibitors prior 3 months
- History of radiation therapy
- Taking active cancer treatment
- Undergoing salvage therapy
- Castration-resistant prostate cancer
- Evidence of metastasis
- Evidence of biochemical recurrence
- High risk medical condition (e.g. gout or kidney disease)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：非随机化
- 介入模型：并行分配
- 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：Weight loss intervention Group
Participants will receive tailor weight loss program.
Participants will complete 8-weeks of the weight loss intervention prior to having their prostatectomy (weight loss phase).
Program includes individual weight coaching, tailored diet and exercise plan, weight coaching and tracking of daily activities.
Sessions will be held weekly during the weight loss phase.
The groups will be facilitated by a registered dietitian with genitourinary (GU) oncology experience.
|
Program has four main components: diet, physical activity, coaching and diet and exercise monitoring.
The program is tailored to each individual in the study.
|
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有源比较器：Comparison Group
All patients who are unwilling or not ready to engage in a weight loss program will be offered entry into the comparison group arm.
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Standard of Care for this patient population.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Change in body weight during the post-surgical period
大体时间：Change from Surgery to Week 20
|
Change from Surgery to Week 20
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in body weight during the pre-surgical weight-loss intervention
大体时间：Change from Baseline to Week 8
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Change from Baseline to Week 8
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Changes in diet quality during the pre-surgical weight-loss intervention
大体时间：Change from Baseline to Week 8
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Changes will be measured by analyzing results from alternative healthy eating index scores.
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Change from Baseline to Week 8
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Prostate cancer status
大体时间：Week 20
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Evidence of recurrence of cancer
|
Week 20
|
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Change in cardiovascular biomarkers
大体时间：Change from Baseline to Week 20
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Changes will be measured by analyzing changes in participants lipid panel, c-reactive protein, fasting insulin and fasting glucose.
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Change from Baseline to Week 20
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jill Hamilton-Reeves, PhD, RD, LD、University of Kansas Medical Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年10月1日
初级完成 (实际的)
2016年6月1日
研究完成 (实际的)
2016年6月1日
研究注册日期
首次提交
2014年9月18日
首先提交符合 QC 标准的
2014年9月25日
首次发布 (估计)
2014年9月30日
研究记录更新
最后更新发布 (估计)
2016年9月7日
上次提交的符合 QC 标准的更新
2016年9月6日
最后验证
2016年9月1日
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.