Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy (PROACTIVE)
Breast cancer and its treatments can take a toll on the physical and psychosocial well-being of cancer survivors. Few interventions can help breast cancer patients improve their physical strength, stamina, and overall well-being. Developing ways to facilitate PA behavior during chemotherapy for breast cancer are necessary. This trial explores ways that breast cancer patients receiving chemotherapy can learn about and engage in PA during chemotherapy. This trial will also give Southern Alberta breast cancer survivors an opportunity to participate in evidence-based programs designed to facilitate their health, breast cancer recovery, and disease-free survival.
The investigators primary hypothesis is that women receiving the PA intervention resource kit will report a more positive change in self-reported PA at the end of chemotherapy treatments when compared to the group receiving standard materials.
研究概览
详细说明
Primary Objective:
To compare the effects of an evidence-based intervention consisting of targeted breast-cancer specific PA print materials (i.e., Exercise for health), a step pedometer, a step-walking guidebook (i.e., Step into survivorship), and a physical activity and step journal (INT) to a comparison group receiving a generic, two-page public health PA resource (Standard Material: SM).
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
-
-
Alberta
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Calgary、Alberta、加拿大
- 招聘中
- Tom Baker Cancer Centre
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Grande Prairie、Alberta、加拿大
- 招聘中
- Grande Prairie Cancer Centre
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Lethbridge、Alberta、加拿大
- 招聘中
- Lethbridge Cancer Centre
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Medicine Hat、Alberta、加拿大
- 招聘中
- Medicine Hat Cancer Centre
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Red Deer、Alberta、加拿大
- 招聘中
- Central Alberta Cancer Centre
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- are diagnosed with stage I -IIIA breast cancer
- are scheduled to receive neoadjuvant or adjuvant chemotherapy
- did not receive transabdominal rectus abdominus muscle (TRAM) reconstructive surgery
- are >18 years of age
- receive approval from their treating oncologist to participate
- do not have uncontrolled hypertension, cardiac illness, or psychiatric conditions (i.e., indicated in patient medical charts).
学习计划
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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实验性的：PA Behavior Intervention
Physical Activity Resource Kit
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The Intervention group (INT) will receive a Physical Activity Resource Kit which includes a step pedometer, a breast cancer-specific Physical Activity Guidebook (Exercise for health), a step pedometer resource (Step into survivorship), and a physical activity and step journal to record their daily step totals and daily physical activities. Participants will be instructed to wear their pedometer for the entire duration of the study (i.e., chemotherapy duration). |
|
有源比较器：Standard Materials
Receive physical activity handout from the Canadian Public Health Agency
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Participants in this usual care group will receive a generic physical activity leaflet from the Canadian Public Health Agency
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Self-reported physical activity
大体时间：Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Cancer specific health related quality of life
大体时间：Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
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Psychosocial health outcomes
大体时间：Baseline, post intervention, 6 months follow up
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Baseline, post intervention, 6 months follow up
|
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Objective step counts (pedometer)
大体时间：Baseline, post intervention, 6 months follow up
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Baseline, post intervention, 6 months follow up
|
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Chemotherapy completion rate
大体时间：Baseline, post intervention, 6 months follow up
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Baseline, post intervention, 6 months follow up
|
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Determinants of physical activity
大体时间：Baseline, post intervention, 6 months follow up
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Baseline, post intervention, 6 months follow up
|
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Physical functioning
大体时间：Baseline, post intervention, 6 months follow up
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Baseline, post intervention, 6 months follow up
|
合作者和调查者
调查人员
- 首席研究员：Jeff Vallance, PhD、Athabasca University
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
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.