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RECRUITINGNA

Development and Validation of a Personalized Digital Healthcare Model for Managing Side Effects in Breast Cancer Survivors

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

NCT06729684•Samsung Medical Center

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 65 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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

Locations (1)

Samsung Medical Center

Seoul, Republic of Korea, South Korea

Key Dates

Start Date

November 13, 2024

Primary Completion Date

May 31, 2025

Completion Date

May 31, 2025

Last Updated

December 11, 2024

Enrollment

ESTIMATED participants

Conditions

Breast Cancer SurvivorshipBreast CancerDigital Health

Interventions

digital health (application and smartwatch)

DEVICE

Contacts

Sun Woo Kim, MS

CONTACT

+82-2-2008-4192 k.sunwoo0418@gmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Development and Validation of a Personalized Digital Healthcare Model for Managing Side Effects in Breast Cancer Survivors

Inclusion Criteria

Exclusion Criteria

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