Intelligent Remote Intervention for High-risk Breast Cancer Populations

ConditionsUltrasonography Breast Neoplasm Female Breast Carcinoma Health Education

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-60

SponsorQianfoshan Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

the Remote Intervention
Other intervention
Remote health intervention refers to the use of big data, artificial intelligence and 5G technology to provide healthcare services and interventions to individuals at a distance. This approach allows healthcare providers to deliver medical care, monitor patients' health, offer consultations, provide education, and offer support without the need for in-person interaction.
the Traditional Intervention
Other intervention
Ultrasound follow-up review is recommended. If there is suspicious change in the lesion during follow-up, biopsy should be considered to clarify the nature of the pathology.

Treatment groups

1,250 Participants

are divided into 2 treatment groups

Group A: the Experimental GroupExperimental treatment 1 intervention

Group B: the Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

BI-RADS grade changes in breast nodules

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.

Time frame

3 years

Secondary outcomes

The differences in the risk of developing into breast cancer

During the follow up period, check risk of breast cancer in both the experimental and the control group, to see the difference. The numbers and rates of developing into breast cancers of the experimental and the control group will be computed, and their statistically significance will be evaluated using student-t test or chi-square test. All the analysis will be performed with R software version 4.3.1.

Time frame

3 years

Other outcomes

The knowledge, belief and behavioral changes

During the follow up period, check the knowledge, belief and behavioral changes in both the experimental and the control group, to see the difference. The 'knowledge' section consists of 22 questions, including basic knowledge, factors contributing to the disease, and self-examination awareness. The 'belief' section comprises 7 questions, including statements like "I can maintain good lifestyle habits" and "I can comfortably discuss breast issues." The breast cancer 'behavior' section comprises 4 questions, including statements like "If I notice any abnormalities in my breasts, I will seek medical attention" and "I have performed breast self-examinations before." All questions are multiple-choice, with each question scored as 1 point for 'aware/agree/done' and 0 points for 'unaware/disagree/not done.' The total KAP score is 33 points, where a higher score indicates a higher level of knowledge, belief, and behavior related to breast cancer.

Time frame

3 years

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qianfoshan Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: