Assessment of the Effect of Intelligence Remote Intervention on High-Risk Populations for Breast Cancer
Trial ID: NCT06193707
Status: NOT_YET_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2024-01
Completion date: 2027-12
Sponsor: Qianfoshan Hospital
Conditions: Ultrasonography; Breast Neoplasm Female; Breast Carcinoma; Health Education
Interventions: the Remote Intervention; the Traditional Intervention
Enrollment: 1250
Age range: 18 Years - 60 Years
Sex: FEMALE

Summary:
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.

Eligibility criteria:
Inclusion Criteria:

* Female; Age\>=18; Having breast BI-RADS 3 nodules or higher; Informed consent signed.

Exclusion Criteria:

* 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.

Outcomes:
BI-RADS grade changes in breast nodules