Feasibility of a Walking Program for Cancer Survivors Receiving Radiation Therapy (PEDWAY)
2017年5月1日 更新者：Margie McNeely、University of Alberta
Feasibility of a Supported Walking Program for Breast and Head-and-Neck Cancer Survivors Receiving Adjuvant Radiation Therapy
This pilot study will assess whether a supported pedometer-based walking program is helpful in maintaining physical activity for breast and head-and-neck cancer patients who are undergoing radiation therapy.
Follow-up monitoring sessions will be scheduled to help provide support for physical activity during radiation therapy.
We will also examine the relationship of physical activity and quality of life outcomes to help inform future research.
研究概览
详细说明
Will the integration of a patient-centered exercise prescription and supportive counseling attenuate declines in physical activity during radiation therapy?
To address this question, this study will assess the feasibility of a patient-centered walking program for breast and head-and-neck cancer patients undergoing radiation therapy.
Follow-up monitoring sessions will be scheduled to help provide support and ongoing counseling to facilitate increased activity (through walking) during radiation therapy.
We will also examine the effect of the walking program on other outcomes such as happiness, depression and sleep to determine point estimates and measures of variability to inform future research.
研究类型
介入性
注册 (实际的)
21
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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Alberta
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Edmonton、Alberta、加拿大、T6J4P9
- Cross Cancer Institute
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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
Inclusion Criteria:
- Survivors with a diagnosis of breast cancer or head and neck cancer
- Adults aged 18 years or older
- Commencing adjuvant radiation therapy treatments
- Karnofsky Performance Status greater than or equal to 60%
Exclusion Criteria:
- Clinical or radiological evidence of active disease, either local or metastatic
- Serious non-malignant disease, such as cardiac failure or advanced arthritis of weight bearing joints, which would preclude daily treatment and follow-up
- Patients for whom physical activity or exercise is contraindicated
- Psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol
- Unable to comply with the protocol, measurement and follow-up schedule (e.g., scheduling conflicts, time commitment)
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 |
|---|---|
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实验性的：Walking Intervention
Pedometer Walking Program
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All subjects will be prescribed a low-intensity walking program based on their current activity level and an daily assigned step count goal (with the current physical activity recommendations of 30 minutes of moderate-to-vigorous activity per day or 150 minutes per week as the ideal goal).
Participants will be provided with face-to-face counseling and written material describing their specific individualized walking program.
Participants will also be instructed to maintain their normal activities as much as possible during the intervention period.
Participants will be given a pedometer and instructed to wear it at least 5 days per week for the duration of the study.
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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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Accrual Rate and Completion Rate
大体时间：Anticipated duration of radiation therapy of 6 weeks
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Accrual: Number of participants agreeing to participate divided by the number of eligible participants Completion rate: number of participants completing the trial
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Anticipated duration of radiation therapy of 6 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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Adherence
大体时间：Anticipated duration of radiation therapy of 6 weeks
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Adherence to the intervention protocol: number of days meeting target step count
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Anticipated duration of radiation therapy of 6 weeks
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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6-Minute Walk Test
大体时间：Change from baseline to anticipated end of radiation therapy of 6 weeks
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The six-minute walk test (6MWT) measures the distance an individual is able to walk over a six minutes time period on a hard, flat surface (e.g., 100 foot hallway).
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Change from baseline to anticipated end of radiation therapy of 6 weeks
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Physical Activity
大体时间：Change from baseline to anticipated duration of radiation therapy of 6 weeks
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An accelerometer armband will be used to provide a breakdown of an individual's daily activity.
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Change from baseline to anticipated duration of radiation therapy of 6 weeks
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Self-esteem
大体时间：Change from baseline to anticipated duration of radiation therapy of 6 weeks
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Rosenberg Self-Esteem Scale (10 item)
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Change from baseline to anticipated duration of radiation therapy of 6 weeks
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Depression
大体时间：Change from baseline to anticipated duration of radiation therapy of 6 weeks
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Beck Depression Inventory II (21 item)
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Change from baseline to anticipated duration of radiation therapy of 6 weeks
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Happiness
大体时间：Change from baseline to anticipated duration of radiation therapy of 6 weeks
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Oxford Happiness Questionnaire (29 items)
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Change from baseline to anticipated duration of radiation therapy of 6 weeks
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Sleep
大体时间：Change from baseline to anticipated duration of radiation therapy of 6 weeks
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Pittsburgh Sleep Quality Index (9 item)
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Change from baseline to anticipated duration of radiation therapy of 6 weeks
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Fatigue
大体时间：Recorded daily during study period of 6 weeks
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Visual analogue scale, recorded as part of daily diary
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Recorded daily during study period of 6 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
- 首席研究员：Margaret McNeely, PhD、University of Alberta and Cross Cancer Institute
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6月1日
初级完成 (实际的)
2013年10月1日
研究完成 (实际的)
2013年12月1日
研究注册日期
首次提交
2013年6月16日
首先提交符合 QC 标准的
2013年6月25日
首次发布 (估计)
2013年6月26日
研究记录更新
最后更新发布 (实际的)
2017年5月3日
上次提交的符合 QC 标准的更新
2017年5月1日
最后验证
2017年5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.
Pedometer Walking Program的临床试验
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University of ManchesterNational Secretariat of Science, Technology and Innovation in Panama (SENACYT)完全的
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University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的
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The University of Hong KongSydney Children's Hospitals Network; SAHK招聘中
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Rigshospitalet, DenmarkNovo Nordisk A/S; Copenhagen University Hospital at Herlev; Danish Cancer Society; TrygFonden, Denmark完全的
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Ghana Health ServicesKwame Nkrumah University of Science and Technology尚未招聘戒烟 | 减少吸烟 | 吸烟，烟草 | 吸烟行为
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Medical University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)完全的肥胖 | 心血管危险因素 | 糖尿病风险