Hula, a Physical Activity Intervention for Female-Cancer Survivors
2019年4月16日 更新者：University of Hawaii
A six-month interventional program to determine the biological and psychosocial effects of hula as a form of physical activity for female breast, cervical, endometrial or ovarian cancer survivors living on Oahu.
研究概览
研究类型
介入性
注册 (实际的)
73
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
-
-
Hawaii
-
Honolulu、Hawaii、美国、96813
- University of Hawaii Cancer Center
-
-
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 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Lives on Oahu
- Diagnosed with primary breast,cervical, endometrial or ovarian cancer (stage I-III)
- Completed initial regional and systemic treatment for breast cancer 2 months ago
- Physically capable of doing the hula-based physical activity
- Receives approval by attending physician to participate in trial
Exclusion Criteria:
- Currently undergoing chemotherapy or radiation therapy
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：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Hula
Hula is an ancient, Native Hawaiian dance form of cultural expression and physical activity.
Participants will attend one-hour hula classes twice a week for six months.
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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 |
|---|---|---|
|
Hula Program Feasibility (Compliance as measured by the proportion of total sessions attended and a questionnaire regarding satisfaction with the program at the end of the intervention)
大体时间：6 months after the start of the intervention program
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Compliance as measured by the proportion of total sessions attended and a questionnaire regarding satisfaction with the program at the end of the intervention
|
6 months after the start of the intervention program
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Biomarkers - Sex Hormones (Circulating levels of sex hormones measured in serum samples)
大体时间：Baseline, 6 months and 12 months after the start of the intervention program
|
Circulating levels of sex hormones measured in serum samples.
|
Baseline, 6 months and 12 months after the start of the intervention program
|
|
Biomarkers - Cytokines (Circulating levels of cytokines measured in serum samples.)
大体时间：Baseline, 6 months and 12 months after the start of the intervention program
|
Circulating levels of cytokines measured in serum samples.
|
Baseline, 6 months and 12 months after the start of the intervention program
|
|
Biomarkers - Inflammatory Markers (Circulating levels of leptin, CRP, IGF-1, and IGFBP3 measured in serum samples collectively.)
大体时间：Baseline, 6 months and 12 months after the start of the intervention program
|
Circulating levels of leptin, CRP, IGF-1, and IGFBP3 measured in serum samples collectively.
|
Baseline, 6 months and 12 months after the start of the intervention program
|
|
DNA Methylation Patterns (DNA methylation patterns as detected with the Illumina Assay containing methylation sites in RefSeq genes and CpG islands collectively.)
大体时间：Baseline, 6 months and 12 months after the start of the intervention program
|
DNA methylation patterns as detected with the Illumina Assay containing methylation sites in RefSeq genes and CpG islands collectively.
|
Baseline, 6 months and 12 months after the start of the intervention program
|
|
Self-Report Outcomes - Demographics (Collectively looking at demographic items as measured on the baseline questionnaire, including ethnicity, education, family, history of cancer, stage of cancer, treatment type, and comorbidities.)
大体时间：Baseline, 6 months and 12 months after the start of the intervention program
|
Collectively looking at demographic items as measured on the baseline questionnaire, including ethnicity, education, family, history of cancer, stage of cancer, treatment type, and comorbidities.
|
Baseline, 6 months and 12 months after the start of the intervention program
|
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Self-Report Outcomes - Physical Activity (Minutes per week of exercise assessed using The Women's Health Initiative Physical Activity Questionnaire)
大体时间：Baseline, 6 months and 12 months after the start of the intervention program
|
Minutes per week of exercise assessed using The Women's Health Initiative Physical Activity Questionnaire
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Baseline, 6 months and 12 months after the start of the intervention program
|
|
Self-Report Outcomes - Health-Related Quality of Life (Quality of life of participants assessed using The European Organization for Research and Treatment of Cancer QLQ-C30.)
大体时间：Baseline, 6 months and 12 months after the start of the intervention program
|
Baseline, 6 months and 12 months after the start of the intervention program
|
|
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Self-Report Outcomes - Fatigue (assessed using The Brief Fatigue Inventory (BFI)
大体时间：Baseline, 6 months and 12 months after the start of the intervention program
|
The severity and impact of fatigue on daily functioning assessed using The Brief Fatigue Inventory (BFI).
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Baseline, 6 months and 12 months after the start of the intervention program
|
|
Self-Report Outcomes - Depression (indicated using The Centers for Epidemiological Studies Depression Scale (CES-ED)
大体时间：Baseline, 6 months and 12 months after the start of the intervention program
|
The presence of depression as indicated using The Centers for Epidemiological Studies Depression Scale (CES-ED).
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Baseline, 6 months and 12 months after the start of the intervention program
|
|
Self-Report Outcomes - Affective States (assessed using The Profile of Mood States short form (POMS-SF) questionnaire.)
大体时间：Baseline, 6 months and 12 months after the start of the intervention program
|
Affect of participants assessed using The Profile of Mood States short form (POMS-SF) questionnaire.
|
Baseline, 6 months and 12 months after the start of the intervention program
|
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Self-Report Outcomes - Social Constraints (assessed using The 10-item Social Constraints Scale.)
大体时间：Baseline, 6 months and 12 months after the start of the intervention program
|
How people adjust and cope with a cancer diagnosis assessed using The 10-item Social Constraints Scale.
|
Baseline, 6 months and 12 months after the start of the intervention program
|
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Self-Report Outcomes - Cognitive Functioning (assessed using the 42-item FACTcog
大体时间：Baseline, 6 months and 12 months after the start of the intervention program
|
2 subscales assess cognitive deficiency and cognitive capability
|
Baseline, 6 months and 12 months after the start of the intervention program
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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：Erin Bantum, MA, PhD、University of Hawaii Cancer Research Center
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
2013年9月1日
初级完成 (实际的)
2017年12月1日
研究完成 (实际的)
2017年12月1日
研究注册日期
首次提交
2015年1月20日
首先提交符合 QC 标准的
2015年1月29日
首次发布 (估计)
2015年1月30日
研究记录更新
最后更新发布 (实际的)
2019年4月18日
上次提交的符合 QC 标准的更新
2019年4月16日
最后验证
2019年4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.