Web-based Lifestyle Trial Among Men With Prostate Cancer: Prostate 8 (Prostate 8)
2019年2月20日 更新者：University of California, San Francisco
A Randomized Clinical Trial of Web-based Lifestyle Tools and Resources Versus Usual Care Among Men With Prostate Cancer
A randomized controlled trial of a technology-based lifestyle intervention vs. usual care among men with low-risk prostate cancer to determine the feasibility and acceptability of the intervention and the effect of the intervention on behavior change related to exercise, diet, and not smoking.
研究概览
详细说明
This is a PI-initiated, randomized, unblinded, clinical trial of a technology-based 3 month lifestyle intervention vs. usual care among men with low risk prostate cancer.
We will recruit and consent 76 men with prostate cancer at UCSF.
The subjects will be asked to complete questionnaires, 7 days accelerometer measurement, body measurements (weight, waist, hip, pulse, blood pressure) and collection of blood specimen at baseline and 3 months.
Subjects will be randomized into two arms (Intervention Group and Control Group).
The Intervention Group (N=38) will have access to the lifestyle website and an activity monitor (e.g., Fitbit), receive text messages, and be provided with individualized lifestyle recommendations.
The Control Group (N=38) will have standard of care and be asked to continue with their usual lifestyle habits.
They will receive access to the lifestyle website and be provided with individualized lifestyle recommendations at 3 months.
研究类型
介入性
注册 (实际的)
76
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
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California
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San Francisco、California、美国、94143
- University of California, San Francisco (UCSF)
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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
18年 及以上 (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:
- clinical stage ≤T3a nonmetastatic prostate cancer within 5 years
- completion of treatment ≥3 months prior to enrollment, if not on active surveillance
- ability to walk unassisted
- be able to speak and read English
- ability to navigate websites and email, and have internet access
- able to travel to UCSF for pre- and post-study blood collection
Exclusion Criteria:
- any contraindications to moderate or vigorous aerobic exercise
- psychiatric condition preventing the patient from giving informed consent or adhering to the study protocol
- reporting adherence to more than 4 of the 8 targeted lifestyle behaviors via questionnaires at screening
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：支持治疗
- 分配：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 |
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实验性的：Group 1- Lifestyle Intervention
Men will receive a web-based, personalized lifestyle program.
They will receive personalized prostate cancer-specific lifestyle recommendations on specific habits based on their eligibility survey responses.
They will have access to the website composed of four topic areas (get active, eat well, stop smoking, and find support), receive a Fitbit and access to a Fitbit account and community group, and receive text messages and refrigerator magnet to reinforce behaviors.
The website will be updated frequently with new tips and material and two weekly blogs will be maintained.
Final content is reviewed by study investigators and patient advocates.
Men will complete an intervention acceptability survey (acceptability of the website and intervention components) at 3 months.
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Patients will have access to the lifestyle website and an activity monitor (e.g., Fitbit), receive texts, and be provided with individualized lifestyle recommendations.
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无干预：Group 2 - Control
Men randomized to the control group will receive standard of care.
They will receive access to the website and personalized lifestyle recommendations on the 8 healthy habits targeted in the study after the 3 month trial.
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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 |
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Fitbit use
大体时间：3 months
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We will measure the number of days the Fitbit was used during the study period in the intervention arm only to assess study feasibility
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3 months
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text message use
大体时间：3 months
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We will measure the number of text messages responded to that required a reply in the intervention arm only during the study period to assess study feasibility
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3 months
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website use - number of days the website was visited
大体时间：3 months
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We will measure the total number of days the website was visited in the intervention arm only during the study period to assess study feasibility
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3 months
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website use - number of website visits
大体时间：3 months
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We will measure the total number of website visits in the intervention arm only during the study period to assess study feasibility
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3 months
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intervention acceptability
大体时间：3 months
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We will assess intervention acceptability via questionnaire at 3 months in the intervention group.
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3 months
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self-reported change in health behaviors
大体时间：3 months
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We will assess change in health behaviors via questionnaire at baseline and 3 months.
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3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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change in physical activity measured by activity monitor
大体时间：3 months
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This is assessed via 7-day accelerometer measurements at baseline and 3 months.
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3 months
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change in task self-efficacy
大体时间：3 months
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We will assess confidence in performing behaviors via questionnaire at baseline and 3 months.
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3 months
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change in plasma antioxidant Vitamin E
大体时间：3 months
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We will assess Vitamin E levels at baseline and 3 months.
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3 months
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change in plasma antioxidant lycopene
大体时间：3 months
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We will assess lycopene levels at baseline and 3 months.
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3 months
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change in fasting glucose
大体时间：3 months
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We will assess fasting glucose at baseline and 3 months.
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3 months
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change in cholesterol
大体时间：3 months
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We will assess cholesterol at baseline and 3 months.
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3 months
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change in hemoglobin A1c
大体时间：3 months
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We will assess hemoglobin A1c at baseline and 3 months.
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3 months
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change in C-reactive protein
大体时间：3 months
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We will assess C-reactive protein at baseline and 3 months.
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3 months
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change in waist circumference
大体时间：3 months
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We will assess waist circumference at baseline and 3 months.
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3 months
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change in weight
大体时间：3 months
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We will assess weight at baseline and 3 months.
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3 months
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change in body mass index
大体时间：3 months
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We will assess body mass index at baseline and 3 months.
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3 months
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depression
大体时间：3 months
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Center for Epidemiologic Studies Depression Scale completed at baseline and 3 months.
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3 months
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anxiety
大体时间：3 months
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Memorial Anxiety Scale for Prostate Cancer and State Anxiety completed at baseline and 3 months.
Trait anxiety completed at baseline.
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3 months
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health-related quality of life
大体时间：3 months
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Expanded Prostate Cancer Index Composite-26 and Short Form Health Survey-36 completed at baseline and 3 months.
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3 months
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maintenance or adoption of self-reported behaviors after 1 year
大体时间：1 year
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We will assess change in health behaviors via questionnaire at baseline, 3 months, and 1 year.
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1 year
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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：Stacey Kenfield, ScD、University of California, San Francisco
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 (实际的)
2015年6月1日
初级完成 (实际的)
2017年6月1日
研究完成 (实际的)
2018年3月1日
研究注册日期
首次提交
2015年6月10日
首先提交符合 QC 标准的
2015年6月11日
首次发布 (估计)
2015年6月12日
研究记录更新
最后更新发布 (实际的)
2019年2月22日
上次提交的符合 QC 标准的更新
2019年2月20日
最后验证
2019年2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.
Lifestyle intervention的临床试验
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University of HawaiiNational Heart, Lung, and Blood Institute (NHLBI); National Association of Pasifika Organizations 和其他合作者邀请报名血脂异常 | 糖尿病前期 | 2 型糖尿病 (T2DM) | 高血压 (HTN) | 超重（BMI > 25） | 减肥试验 | 心脏代谢状况美国
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Ege Miray Topcu完全的
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University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)尚未招聘
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动，不招人