Development and Validation of Personalized Digital Healthcare Technology and Service Model for the Management and Recovery of Side Effects of Treatment in Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- PROMIS29
研究概览
简要总结
The ultimate goal of this research and development is to develop personalized digital healthcare technologies and self-management strategies based on self-assessment results and evidence, for breast cancer survivors who require management and recovery from acute and chronic side effects related to various treatments (surgery, chemotherapy, radiation, hormone therapy, etc.). Additionally, the aim is to verify the clinical applicability and establish a service model to address the diverse unmet healthcare needs of breast cancer survivors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Individuals who have undergone surgery for Stage 1-2 breast cancer
- •Individuals who have had a unilateral mastectomy
- •Aged 18 years or older and under 65 years
- •Possessing a smartphone with either an Android or iOS operating system
- •Individuals who voluntarily decide to participate after receiving detailed information about the study and provide written consent
排除标准
- •Individuals who have undergone mastectomy only and are not receiving chemotherapy, radiation, or hormone therapy
- •Individuals with severe comorbidities (such as underlying diseases, neuromuscular disorders, cognitive or mental impairments, visual disabilities, etc.) that make it difficult to use the application or participate in the exercise intervention
- •Discontinuation Criteria
- •Individuals who undergo delayed breast reconstruction surgery during the study period
- •Individuals who develop severe complications or experience cancer metastasis or recurrence in other organs during the study period, leading to a change in treatment
- •Occurrence of a major illness unrelated to study participation
- •Failure to comply with the instructions of the study physician
- •Situations where the participant voluntarily withdraws from the study or becomes unable to continue participating
研究组 & 干预措施
control (Conventional Treatment)
- breast cancer surgery with CTx/RTx/HTx
- brochure training
intervention (digital health)
- breast cancer surgery with CTx/RTx/HTx
- brochure training
- add digital health (application + smartwatch)
干预措施: digital health (application and smartwatch) (Device)
结局指标
主要结局
PROMIS29
时间窗: Baseline, Month 1, Month 3, Month 6
Full Title: Patient-Reported Outcomes Measurement Information System Objective: health related quality of life Scoring System: Each item is rated on a scale of 1 to 5. Lower scores indicate better health for pain, depression, anxiety, and fatigue, while higher scores indicate better health for physical function, social roles, and activities, and sleep disorders.
次要结局
- EQ-5D-5L(Baseline, Month 1, Month 3, Month 6)
- PRO-CTCAE(Month 1, Month 3, Month 6)
- ICF (International Classification of Functioning, Disability, and Health)(Baseline, Month 1, Month 3, Month 6)
- Activity (step count)(Baseline, Month 1, Month 3, Month 6)
- TTM (Transtheoretical Model)(Baseline, Month 3, Month 6)
- OBQ-K(Baseline, Month 3, Month 6)
- CBI-K(Baseline, Month 3, Month 6)
- body composition (inbody)(Baseline, Month 1, Month 3, Month 6)
研究者
JiHye Hwang
Professor
Samsung Medical Center