适应电子健康(Web 应用程序)平台以在前列腺癌患者中提供久坐行为干预
2022年3月8日 更新者:Wake Forest University Health Sciences
本研究的总体目标是调整和完善现有的电子健康(网络应用程序/网络应用程序/应用程序)平台,旨在促进老年人和前列腺癌患者的自发运动(减少久坐行为)。
研究概览
详细说明
前列腺癌 (PCa) 的主要治疗会加速与衰老相关的身体成分变化以及身体机能和生活质量的下降; PCa 诊断的中位年龄为 66 岁,大约 64% 的 PCa 幸存者年龄 > 70 岁。
治疗的负面影响在患有合并症的老年、久坐、超重或肥胖男性中更为明显。
伴随而来的骨骼肌质量下降、脂肪组织沉积增加和骨矿物质密度下降会导致骨折、癌症相关疲劳、虚弱、身体机能受损、残疾和丧失独立性以及焦虑和抑郁。
规律的体育锻炼可以降低发病率、提高生存率并可以缓解 PCa 患者对治疗的负面影响,但只有不到 20% 的患者符合推荐的指南——而且大多数人每天将多达 70% 的时间花在久坐行为上。
通过促进规律的自发运动和规律的阻力训练来减少久坐行为,对于可能会疲劳和功能受损的 PCa 患者来说可能是一种有效的方法。
传统的基于理论的运动干预已显示出促进短期运动的初步疗效,但可以改进以提高长期疗效。
传统的运动干预通常不是针对个人量身定制的,因此无法结合行为理论在自我调节失误时重新吸引参与者。
电子健康技术可以增强传统的基于理论的运动干预。
研究小组假设电子健康提供的干预措施可以有效地促进自我调节技能的发展和维持,这对于维持长期行为改变至关重要。
研究类型
观察性的
注册 (实际的)
4
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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North Carolina
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Winston-Salem、North Carolina、美国、27157
- Wake Forest Baptist 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
- 成人
- OLDER_ADULT
- 孩子
接受健康志愿者
不
有资格学习的性别
男性
取样方法
概率样本
研究人群
目前正在接受治疗的前列腺癌患者
描述
纳入标准:
- 经组织学证实的前列腺癌。
- 目前(过去 2 年)在 WFBMC 接受前列腺癌治疗。
- 目前拥有智能手机或平板电脑(iOS 和主要品牌的 Android 设备,不包括电子阅读器)。
- 英语会话。
排除标准:
- 无法提供知情同意(例如,精神错乱)。
- 无法安全地走动(跌倒风险)。
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
队列和干预
团体/队列 |
干预/治疗 |
---|---|
前列腺癌患者
在过去两年期间一直通过维克森林浸信会综合癌症中心和/或卫星诊所积极接受治疗的前列腺癌患者将使用 eHealth for Sedentary Behavior。
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前列腺癌患者将测试 eHealth 网络应用程序对久坐行为的可用性和可接受性
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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 |
---|---|---|
评估网络应用程序的设计特性和功能
大体时间:45分钟
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参与者将接受有关网络应用程序功能的定性访谈。
将使用主题内容分析 (TCA) 来评估有声思考和访谈数据。
成绩单将导入 ATLAS.ti
软件(第 8 版,德国柏林),并由研究团队使用迭代方法进行审查。
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45分钟
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系统可用性量表
大体时间:30分钟
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参与者将回答 10 个 5 分李克特式问题,以收集对网络应用程序可用性的看法。
总分10-50,分数越高表示效果越好
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30分钟
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参与者对网络应用程序功能的反思
大体时间:30分钟
|
报告对应用程序功能的开放式定性反思的描述性统计数据将使用主题内容分析作为录音进行编码。
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30分钟
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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:Rhonda L Bitting, MD、Duke Cancer Institute
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。
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- De Cocker K, Duncan MJ, Short C, van Uffelen JG, Vandelanotte C. Understanding occupational sitting: prevalence, correlates and moderating effects in Australian employees. Prev Med. 2014 Oct;67:288-94. doi: 10.1016/j.ypmed.2014.07.031. Epub 2014 Aug 10.
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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)
2018年8月13日
初级完成 (实际的)
2018年10月17日
研究完成 (实际的)
2019年6月18日
研究注册日期
首次提交
2018年11月9日
首先提交符合 QC 标准的
2018年11月9日
首次发布 (实际的)
2018年11月14日
研究记录更新
最后更新发布 (实际的)
2022年3月10日
上次提交的符合 QC 标准的更新
2022年3月8日
最后验证
2022年3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.