Clinical trial · Interventional

Intelligent Remote Intervention for High-risk Breast Cancer Populations

Assessment of the Effect of Intelligence Remote Intervention on High-Risk Populations for Breast Cancer

NCT06193707CI-TRIAL-00072736not yet recruitingN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (4)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Carcinoma	Breast Carcinoma	ONTOLOGY_EXACT	0.98
Breast Neoplasm Female	—	UNRESOLVED	—
Health Education	—	UNRESOLVED	—
Ultrasonography	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
the Remote Intervention	Other	—	UNRESOLVED
the Traditional Intervention	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
the Experimental Group
description
* 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.
interventionNames
1. Other: the Remote Intervention
type
ACTIVE_COMPARATOR
label
the Control Group
description
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

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years

Show eligibility criteria text

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.

References

Publications (6)

BACKGROUNDTorre LA, Siegel RL, Ward EM, Jemal A. Global Cancer Incidence and Mortality Rates and Trends--An Update. Cancer Epidemiol Biomarkers Prev. 2016 Jan;25(1):16-27. doi: 10.1158/1055-9965.EPI-15-0578. Epub 2015 Dec 14. PMID 26667886
BACKGROUNDDeSantis CE, Bray F, Ferlay J, Lortet-Tieulent J, Anderson BO, Jemal A. International Variation in Female Breast Cancer Incidence and Mortality Rates. Cancer Epidemiol Biomarkers Prev. 2015 Oct;24(10):1495-506. doi: 10.1158/1055-9965.EPI-15-0535. Epub 2015 Sep 10. PMID 26359465
BACKGROUNDTaghipour S, Banjevic D, Miller AB, Montgomery N, Jardine AK, Harvey BJ. Parameter estimates for invasive breast cancer progression in the Canadian National Breast Screening Study. Br J Cancer. 2013 Feb 19;108(3):542-8. doi: 10.1038/bjc.2012.596. Epub 2013 Jan 15. PMID 23322203
BACKGROUNDPadilla A, Arponen O, Rinta-Kiikka I, Pertuz S. Image retrieval-based parenchymal analysis for breast cancer risk assessment. Med Phys. 2022 Feb;49(2):1055-1064. doi: 10.1002/mp.15378. Epub 2021 Dec 15. PMID 34837254
BACKGROUNDGreen VL. Breast Cancer Risk Assessment and Management of the High-Risk Patient. Obstet Gynecol Clin North Am. 2022 Mar;49(1):87-116. doi: 10.1016/j.ogc.2021.11.009. PMID 35168775
BACKGROUNDBurka D, Gupta R, Moran AE, Cohn J, Choudhury SR, Cheadle T, Mullick R, Frieden TR. Keep it simple: designing a user-centred digital information system to support chronic disease management in low/middle-income countries. BMJ Health Care Inform. 2023 Jan;30(1):e100641. doi: 10.1136/bmjhci-2022-100641. PMID 36639189