Clinical Feasibility of Mobile App-Based Self-Management for Breast Cancer-Related Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Usability and Acceptability
研究概览
简要总结
The study evaluates a newly developed service that provides personalized self-management guidance based on evidence-based arm circumference measurements and resulting volume changes. The research aims to determine whether this digital solution is practical and acceptable for patients while identifying any unexpected challenges during implementation, ultimately establishing its potential for clinical integration into lymphedema care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 70 years of age
- •Diagnosed with breast cancer-related unilateral upper limb lymphedema
- •Possessing an Android or iOS smartphone
- •Voluntarily deciding to participate and providing written consent after receiving a detailed explanation of this study
排除标准
- •Diagnosed with malignant lymphedema due to metastasis or recurrence
- •Having severe comorbidities (underlying diseases, neuromusculoskeletal disorders, cognitive, mental, or visual impairments, etc.) that make it difficult to use the application and participate in exercise interventions
- •Discontinuation Criteria:
- •Development of serious complications or cancer metastasis/recurrence during the study period
- •Occurrence of a serious illness unrelated to study participation
- •Failure to follow the instructions of the study physician
- •Voluntary withdrawal from the study or development of circumstances preventing participation
研究组 & 干预措施
digital health
Unilateral Upper Limb Lymphedema Associated with Breast Cancer
干预措施: digital health (Application and Smart Measuring Tape) (Device)
结局指标
主要结局
Usability and Acceptability
时间窗: Baseline, Month 3
Self-Developed Questionnaire A. One item on the necessity of a lymphedema self-management app B. 23 items on satisfaction and acceptability C. Scoring scale: 1 (Strongly Disagree) - 6 (Strongly Agree)
SUS
时间窗: Baseline, Month 3
Full Title: System Usability Scale A. A 10-item questionnaire to evaluate system usability B. Score range is 0-100, with a benchmark known to be 68 points Self-developed questionnaire
次要结局
- TTM (Transtheoretical Model)(Baseline, Month 3)
- LYMQOL(Baseline, Month 3)
- EQ-5D-5L(Baseline, Month 3)
- self-efficacy(Baseline, Month 3)
- upper arm use(Baseline, Month 3)
- ICF (International Classification of Functioning, Disability, and Health)(Baseline, Month 3)
- COPM(Baseline, Month 3)
- Perometer(Baseline, Month 3)
- Smart Measuring Tape(Baseline, Month 3)
研究者
JiHye Hwang
Professor
Samsung Medical Center