Assessment of the Effect of Intelligence Remote Intervention on High-Risk Populations for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,250
- 主要终点
- BI-RADS grade changes in breast nodules
研究概览
简要总结
The goal of this clinical trial is to compare the effects of modern remote health intervention regime with traditional in-person intervention strategies for high-risk breast cancer groups that with BI-RADS 3 or higher nodules.
The main questions it aims to answer are:
- Can the remote health intervention be more effective in slowing down the progression of breast nodules than the traditional in-person intervention?
- Can the remote health intervention be more effective in minimizing the deterioration of the disease and reducing the risk of death in patients than the traditional in-person intervention?
- Can the knowledge, belief and behavioral change of breast nodule population improve after receiving remote health intervention compared with traditional health management model?
Participants will be divided into 2 groups, the Experimental group and the Control group. Participants in the Experimental group will be offered with modern remote interventions for 2 years, as describe below:
- Teleconsultations: This involves using video calls, or phone calls once a month to connect patients for consultations, follow-ups, and discussions about conditions and symptom management.
- Remote Monitoring and Wearable Devices: Wearable devices and remote monitoring tools like Infrared Breast Temperature Detector and Dynamic blood pressure detector will be used once a week to track patients' vital signs and symptoms remotely.
- Mobile Applications: Specialized mobile apps will be used to provide a platform for patients to access educational materials, track their progress, manage management schedules, record symptoms, and connect with support groups or online communities.
- Educational Platforms and Remote Health Education: Online platforms and resources provide educational materials about breast cancer, treatment options, potential side effects, lifestyle adjustments, and overall wellness. These resources empower patients by providing comprehensive information.
Participants in the Control group will be offered with traditional strategies provided in the 'Breast Cancer Screening Guideline for Chinese Women': Ultrasound follow-up review is recommended no less than 3 to 6 months later. If there is no change at 2-year follow-up, it can be downgraded to BI-RADS 2; if there is suspicious change in the lesion during follow-up, biopsy should be considered to clarify the nature of the pathology.
详细描述
Breast cancer is one of the world's major public health problems. According to the report of the International Agency for Research on Cancer (IARC) of the World Health Organization (WHO), breast cancer has replaced lung cancer as the world's number one cancer in 2020, posing a serious threat to women's lives and health. Breast nodules are benign lumps or masses that form in the breast tissue. Breast nodules may increase the risk of breast cancer to a certain extent, and enhancing early health management of breast nodules is an effective measure to diagnose and prevent breast cancer. This project aims to construct an intelligent breast cancer intelligent health management system using remote intervention technology. The system includes modules of intelligent breast health information management, breast disease risk assessment and breast stratified intervention, aiming to break through the bottleneck of breast cancer prevention and treatment.
The goal of this clinical trial is to compare the effects of modern remote health intervention regime with traditional in-person intervention strategies in high-risk breast cancer groups that with BI-RADS 3 or higher nodules.
The main questions it aims to answer are:
- Can the remote health intervention be more effective in slowing down the progression of breast nodules than the traditional in-person intervention?
- Can the remote health intervention be more effective in minimizing the deterioration of the disease and reducing the risk of death in patients than the traditional in-person intervention?
- Can the knowledge, belief and behavioral change of breast nodule population improve after receiving remote health intervention compared with traditional health management model?
Research content:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female; Age>=18; Having breast BI-RADS 3 nodules or higher; Informed consent signed.
排除标准
- •Having any other known breast diseases; Having any major malignant diseases; Having no access to the remote devices or don't know how to use them.
结局指标
主要结局
BI-RADS grade changes in breast nodules
时间窗: 3 years
During the follow up period, check the BI-RADS grade changes in both the experimental and the control group, to see the difference. BI-RADS stands for American Breast Imaging Reporting and Data System. It's a standardized system used by radiologists to categorize findings on mammograms. The BI-RADS system ranges from 0 to 6, with each category indicating a different level of suspicion for breast cancer: BI-RADS 0: Incomplete assessment, additional imaging needed. BI-RADS 1: Negative (normal) finding. BI-RADS 2: Benign (non-cancerous) finding. BI-RADS 3: Probably benign finding (less than 2% chance of being cancer). BI-RADS 4: Suspicious abnormality that may be cancerous (the likelihood of cancer increases with higher numbers within this category). BI-RADS 5: Highly suggestive of malignancy (more than 95% chance of being cancer). BI-RADS 6: Known biopsy-proven malignancy.
次要结局
- The differences in the risk of developing into breast cancer(3 years)
研究者
Guang Zhang
Vice President
Qianfoshan Hospital