Facebook-based Physical Activity Intervention for Young Adult Cancer Survivors: the FITNET Randomized Pilot Study (FITNET)
2011年12月12日 更新者：University of North Carolina, Chapel Hill
The purpose of this study is to determine the feasibility and efficacy of a behavioral intervention, delivered through an existing social networking website (Facebook), on physical activity (moderate-intensity minutes per week) among young adult cancer survivors compared to a self-help education condition.
For this research study, investigators will conduct a 12-week randomized trial.
After a baseline survey, weekly messages, a pedometer, goal-setting tool, physical activity log and discussion prompts will be delivered to the intervention group.
Comparison group participants will receive links to websites with self-help education materials.
After 12 weeks, a follow-up survey will be given to both groups.
Changes in physical activity, quality of life and psychosocial factors will be examined.
The investigators hypothesize that those receiving the intervention will have improved physical activity behaviors at 12-week follow-up relative to those in the comparison group.
研究概览
研究类型
介入性
注册 (实际的)
97
阶段
- 第一阶段早期
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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Chapel Hill、North Carolina、美国、27599
- Lineberger Comprehensive Cancer Center at UNC-CH
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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
21年 至 39年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Young adult between ages 21-39 diagnosed with cancer (excluding non-melanoma skin cancer) at age 18 or older
- At least 1 year beyond date of diagnosis with no evidence of progressive disease or second primary cancers
- Completed cancer treatment
- English-speaking and writing
- No pre-existing medical condition(s) or contraindications that preclude adherence to an unsupervised exercise program, including cardiovascular disease, congestive heart failure, pulmonary conditions, renal disease, and severe orthopedic conditions
- Not adhering to the American Cancer Society's recommendation of at least 150 minutes of moderate-intensity exercise per week (<150 minutes/week)
- Have access to Internet service and an active Facebook account
- Willing to be randomized
- Have indicated consent by checking "yes" to the online consent form
Exclusion Criteria:
- Non-English speaking
- < 21 and > 39 years of age
- Diagnosed with cancer less than one year previously or still in treatment
- Pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program, including cardiovascular disease, congestive heart failure, pulmonary conditions, renal disease, and severe orthopedic conditions
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：Facebook-based Self-help Comparison
Participants will receive a pedometer and twelve weekly messages with links to Internet resources that have educational materials related to exercise and cancer survivorship.
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Twelve weekly messages and a pedometer.
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实验性的：Facebook-based Messages/Website
Participants will receive a pedometer, twelve weekly messages, and be encouraged to participate in sixteen Facebook group discussions and use a website for exercise goal-setting and tracking activity.
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Twelve weekly messages, a pedometer, sixteen group discussions, and access to an exercise website to promote increased physical activity.
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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 |
|---|---|
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Primary study outcome measures at the participant level will be minutes of moderate-intensity physical activity per week and exercise in MET-hrs/week.
大体时间：Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
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Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
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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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Quality of life
大体时间：Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
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Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
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Psychosocial factors
大体时间：Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
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Examine potential mediators of the effect of the intervention, including changes in self-efficacy, social support and self-monitoring behaviors
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Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
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Utilization of program components/activities
大体时间：Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
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Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
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Perceptions of program components/activities
大体时间：Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
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Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
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Communication factors
大体时间：Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
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Examine potential mediators of the effect of the intervention, including message trust, relevance and recall
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Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
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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
- 学习椅：Marci K. Campbell, PhD, MPH、University of North Carolina, Chapel Hill
- 首席研究员：Carmina G. Valle, MPH、University of North Carolina, Chapel Hill
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。
一般刊物
- Valle CG, Tate DF. Engagement of young adult cancer survivors within a Facebook-based physical activity intervention. Transl Behav Med. 2017 Dec;7(4):667-679. doi: 10.1007/s13142-017-0483-3.
- Valle CG, Tate DF, Mayer DK, Allicock M, Cai J. A randomized trial of a Facebook-based physical activity intervention for young adult cancer survivors. J Cancer Surviv. 2013 Sep;7(3):355-68. doi: 10.1007/s11764-013-0279-5. Epub 2013 Mar 27.
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
2011年4月1日
初级完成 (实际的)
2011年12月1日
研究完成 (实际的)
2011年12月1日
研究注册日期
首次提交
2011年5月2日
首先提交符合 QC 标准的
2011年5月4日
首次发布 (估计)
2011年5月6日
研究记录更新
最后更新发布 (估计)
2011年12月13日
上次提交的符合 QC 标准的更新
2011年12月12日
最后验证
2011年12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.