Feasibility of a Modular mHealth for Tailored Rehabilitation During the Treatment of Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- DASH (Disabilities of Arm, Shoulder, Hands)
研究概览
简要总结
This study investigated the feasibility of the novel modular mobile health (mHealth) for personalized rehabilitation and explored the participants' satisfaction and app data during treatment of breast cancer.
详细描述
This is prospective, feasible, parallel study in post-operative patients with breast cancer and during treatment. Disability of Arm, Shoulder, Hands (DASH), Physical activity data (IPAQ-SF), Physical measurement such as hand grip strength, body mass index (BMI), muscle mass, and differences in arm circumference, PRO-CTCAE, Distress Thermometer, needs and satisfaction in app, personal health record of app (exercise, daily step count, etc.) Measure will be evaluated on 1-month, 2-month, 4-month, 6-month, 9-month, and 12-month after POD.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Unilateral breast cancer at TNM stage 0 ~ III
- •Patients who will undergo the treatment (chemotherapy, radiation therapy, and hormone therapy) after surgery
- •Patients who had a mobile phone (Android or iOS)
排除标准
- •Patients who have metastases or recurrence to other organs were excluded
结局指标
主要结局
DASH (Disabilities of Arm, Shoulder, Hands)
时间窗: 1 month, 2month, 4month, 6month, 9month, 12month
Change from Baseline DASH score at 12 months, higher scores mean a worse (0-100)
satisfaction score in app contents
时间窗: 1 to 12month
satisfaction score in app contents, Likert scale (5-point, higher scores mean a better)
Needs score in app contents
时间窗: 1 to 12month
Needs score in app contents, Likert scale (5-point, higher scores mean a better)
次要结局
- Physical measurement (of body composition, BMI)(1 to 12month)
- Physical measurement (upper extremity volume)(1 to 12month)
- Physical measurement (handgrip strength)(1 to 12month)
- Physical measurement (of body composition, muscle mass)(1 to 12month)
- Physical activity (IPAQ-SF Questionnaire)(1 to 12month)
- PRO-CTCAE (patients reported outcomes)(1 to 12month)
- Distress thermometer (distress level)(1 to 12month)
- App use data (personal health record)_Exercise compliance rate(1 to 12month)
- App use data (personal health record)_Physical activity change(1 to 12month)
- App use data (personal health record)_sleep(1 to 12month)
- App use data (personal health record)_interest of contents(1 to 12month)
研究者
JiHye Hwang
Professor
Samsung Medical Center