评估社交网络干预以减少与癌症相关的痛苦
2014年5月21日 更新者：Jason Owen, Phd.、Loma Linda University
据推测，与对照组相比，治疗组在生活质量和情绪障碍方面将表现出更大的改善，并且更大程度地参与干预材料将与情绪和生活质量的更大改善相关。
研究概览
详细说明
癌症患者面临一系列社会心理需求，据估计，多达 35% 的癌症幸存者经历了临床上显着的痛苦。
社会心理干预可能有效改善这些患者的生活质量和降低情绪障碍水平。
不幸的是，获得社会心理干预的障碍很普遍，许多人无法获得这些服务。
基于 Internet 的社会心理干预提高了护理的可及性，并提供了额外的方法优势，包括能够轻松收集自我报告数据、跟踪干预暴露情况以及评估特定干预成分的效果。
拟议的研究将评估专门为提供心理治疗和加强癌症幸存者之间的交流而开发的网站是否可以改善癌症幸存者的痛苦，这些癌症幸存者表示他们有很高的痛苦程度。
如果成功，该研究还将提供改进治疗所需的宝贵信息，并充分开展比较基于互联网和面对面治疗的更大规模试验。
研究类型
介入性
注册 (实际的)
347
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
-
-
California
-
Loma Linda、California、美国、92350
- Loma Linda University
-
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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
全部
描述
纳入标准：
- 至少18岁，
- 除了非黑色素瘤皮肤癌以外的先前癌症诊断，
4) 流利的英语，5) 经常访问互联网，以及 6) 存在大于或等于 4 的痛苦，即在使用痛苦温度计进行初步筛查时所确定的大于轻度的痛苦
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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有源比较器：社交网络干预
有兴趣参与该研究的个人将被随机分配到一个为期 12 周的基于互联网的治疗组。
分配到治疗组的受试者将可以访问小组讨论板、结构化的 12 周应对技能培训课程、小组的专业协助、实时聊天板以及其他小组成员建立的个人资料。
受试者将被要求在基线时和参加为期 12 周的小组后再次完成关于痛苦、情绪障碍和生活质量的在线自我报告测量。
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有源比较器：控制组
12 周候补名单控制对象在完成 12 周评估后将能够加入小组，并将被要求完成 24 周评估以衡量随时间的变化。
受试者将可以访问小组讨论板、为期 12 周的结构化应对技能培训课程、小组的专业协助、实时聊天板以及其他小组成员建立的个人资料。
受试者将被要求在基线时和参加为期 12 周的小组后再次完成关于痛苦、情绪障碍和生活质量的在线自我报告测量。
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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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整体心理功能的变化 (OQ-45)
大体时间：3个月的变化
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OQ-45 测量客户的整体功能，由 3 个分量表组成，分别测量主观不适（心理功能）、人际关系和社会角色表现。
OQ-45 具有足够的内部一致性 (a = .93)
和可靠性 (r = .84)
（兰伯特等人，2004 年）。
|
3个月的变化
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流行病学研究抑郁症中心 (CES-D) 量表的变化
大体时间：3个月的变化
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CES-D 是一种自我报告措施，由 20 个项目组成，采用 4 分李克特量表进行评分，以评估上周经历的抑郁症状。
CES-D 已证明具有出色的可靠性和有效性（Radloff，1977）。
标准截止分数 16 将用于识别抑郁症。
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3个月的变化
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焦虑
大体时间：3个月的变化
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情绪状态简要概况 (b-POMS; Shacham, 1983) 的焦虑子量表，它使用 37 个描述性情绪形容词来描述参与者在过去一周内在 5 分李克特量表上的感受。
具体看焦虑（POMS 的 anx 分量表）、活力（POMS 的分量表）和疲劳（POMS 的分量表）。
|
3个月的变化
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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疲劳
大体时间：3个月的变化
|
情绪状态问卷的疲劳子量表
|
3个月的变化
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活力
大体时间：3个月的变化
|
情绪状态问卷的活力分量表。
|
3个月的变化
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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：Jason E Owen, PhD、Loma Linda University
出版物和有用的链接
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有用的网址
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
2009年7月1日
初级完成 (实际的)
2014年5月1日
研究完成 (实际的)
2014年5月1日
研究注册日期
首次提交
2013年9月24日
首先提交符合 QC 标准的
2013年10月30日
首次发布 (估计)
2013年11月6日
研究记录更新
最后更新发布 (估计)
2014年5月22日
上次提交的符合 QC 标准的更新
2014年5月21日
最后验证
2014年5月1日
更多信息
与本研究相关的术语
其他研究编号
- 57065
- PA06-225 (其他赠款/资助编号：Funding Opportunity Number)
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.