Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy
试验速览
- 阶段
- 2 期
- 入组人数
- 150
- 试验地点
- 5
- 主要终点
- Self-reported physical activity
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- 未提供
结局指标
主要结局
Self-reported physical activity
时间窗: Baseline, post intervention, 6 months follow up
次要结局
- Cancer specific health related quality of life(Baseline, post intervention, 6 months follow up)
- Psychosocial health outcomes(Baseline, post intervention, 6 months follow up)
- Objective step counts (pedometer)(Baseline, post intervention, 6 months follow up)
- Chemotherapy completion rate(Baseline, post intervention, 6 months follow up)
- Determinants of physical activity(Baseline, post intervention, 6 months follow up)
- Physical functioning(Baseline, post intervention, 6 months follow up)