Effectiveness of Self-monitoring Physical Activity With a Smartphone Application and Physiotherapy Coaching in Cancer Patients: a Randomized Controlled Trial (SMART-COACH Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- examine the effectiveness of the RunKeeper use with additional physiotherapy coaching
研究概览
简要总结
The aim of this study is to examine whether self-monitoring PA with the RunKeeper app with additional physiotherapy coaching is superior in improving patients' self-reported leisure-time PA compared with usual care in cancer patients after 12 weeks.
This is a single-center, prospective, two-armed, randomized controlled trial. Adult cancer patients and cancer survivors are randomized in one of the two study arms, (Group A) RunKeeper app + physiotherapy coaching or (Group B) usual care.
Patients assigned to the intervention group will be instructed to use the RunKeeper app for 12 weeks to self-monitor leisure-time PA. In addition, patients will be educated about the health risks of a sedentary lifestyle, inactivity and (when applicable) other unhealthy lifestyle behaviors (e.g. unhealthy diet, overweight or obesity, sun exposure, alcohol intake). Benefits of a behavior change, becoming physically active and pursuing a healthy lifestyle will be explained by a trained physiotherapist who will also coach the patient during the PA program. The biweekly physiotherapy coaching starts at baseline and will follow a structured sequence of strategies to change patients PA behavior which will contribute to the adoption of leisure-time PA in patients daily living, so the program will be optimally tailored to the patients capabilities and preferences.
The primary endpoint is to examine the effectiveness of the RunKeeper use with additional physiotherapy coaching in improving patients' leisure-time PA compared with usual care in cancer patients as measured by the PASE subscale leisure-time Sum Score at baseline, 6, 12 and 26 weeks.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >18 years of age diagnosed with cancer (regardless of type/taxonomy) at the medical oncology department, UMCG
- •Patients undergoing cancer treatment or surveillance
- •WHO-performance score ≤1
- •Signed informed consent
排除标准
- •Inability to read or understand the Dutch language
- •Inability to handle or not in possession of a smartphone (iPhone ≥4 or Android phones)
- •Active user of the RunKeeper app
- •Severe cardiac (recent cardiovascular event) or psychiatric disease
- •Patients following supervised oncologic rehabilitation
结局指标
主要结局
examine the effectiveness of the RunKeeper use with additional physiotherapy coaching
时间窗: 6 months
To examine the effectiveness of the RunKeeper use with additional physiotherapy coaching in improving patients' leisure-time PA compared with usual care in cancer patients as measured by the PASE subscale leisure-time Sum Score at baseline, 6, 12 and 26 weeks.
次要结局
- investigate the improvement in the percentage of patients meeting the prescribed total weekly minutes of leisure-time PA(6 months)
- investigate the improvement in patients' weekly total minutes of leisure-time PA and sedentary time(6 months)
- examine the improvement in patients' health-related quality of life (HR-QoL)(6 months)
- examine the improvement in patients' self-efficacy(6 months)
- explore patients' PA Stage of Change(6 months)