Smart After-Care in Patients With Prostate Cancer: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Physical function (2 minute walking test)
研究概览
简要总结
This study aims to examine whether Smart After-Care service (Internet-and mobile-based lifestyle intervention) has an effect on patients' satisfaction and clinical outcomes in patients with prostate cancer on androgen deprivation therapy. Patients with prostate cancer on androgen deprivation therapy will participate in the study. The study design is a randomized controlled trial. The patients were randomly assigned to intervention or usual care groups. Intervention patients received Smart After-Care service for 3 months. Primary endpoint was an increase in patients' physical function as assessed using 2 minute walking test. Secondary endpoints included improvement in muscle strength, short physical performance battery, body composition, and health-related quality of life.
详细描述
After-care is a process targeted towards restoration or maintenance of the physical, mental, intellectual and social abilities of an individual affected by cancer. Internet-and mobile-based lifestyle intervention have emerged as potential modalities to complement and increase accessibility to after-care. In order to meet the growing need for after-care services, we developed a Smart after-care system that will assess the efficacy of a web-based smartphone-enabled intervention. The system provided specialized tools on after-care of prostate cancer including information on nutrition, physical activity, medication adherence, and mobile device that can connect to the smartphone. Patients with prostate cancer on androgen deprivation therapy will be screened for having adequate musculoskeletal and cardiopulmonary function.The study design is a randomized controlled trial. The patients were randomly assigned to intervention or usual care groups. Intervention patients received Smart After-Care management for 3 months. Primary endpoint was an increase in patients' physical function as assessed using 2 minute walking test. Secondary endpoints included improvement in muscle strength, short physical performance battery, body composition, and health-related quality of life.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males diagnosed with prostate cancer
- •Current treatment with ADT (GnRH agonist/antagonist with or without antiandrogen) for a minimum of 6 months after randomization
- •Having Android smartphone
排除标准
- •Having another (active) malignant disease within 3 month before randomization
- •Having severe cardiopulmonary disease
- •Having bone pain due to bone metastasis, (or) pathologic fracture
- •Receiving total knee replacement arthroplasty, (or) total hip replacement arthroplasty
- •No permission from treating/study physician to participate in exercise
研究组 & 干预措施
Intervention: Case management
Case management consists confirmation of hospital visit date, checking the efficacy of intervention, adverse effect and treatment compliance
干预措施: Smart After-Care (Mobile health) (Behavioral)
Control: usual care
Usual care is provided with life style intervention including exercise and nutrition by printed materials.
结局指标
主要结局
Physical function (2 minute walking test)
时间窗: 3 months after randomization
Cardiorespiratory endurance was examined by 2MWT performed on a 15.2-m hallway out-and-back course. Patients were instructed to walk as fast as they could until asked to stop at 2 min; the distance covered was recorded.
次要结局
- Changes in muscle strength(3 months after randomization)
- Changes in short physical performance battery(3 months after randomization)
- Changes in body composition(3 months after randomization)
- Changes in health-related quality of life by EORTC QLQ-C30(3 months after randomization)
- Changes in health-related quality of life by EORTC QLQ-PR25.(3 months after randomization)
研究者
Ji Youl Lee
professor
Seoul St. Mary's Hospital