RecruitingNot ApplicableNCT06729684

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


Sponsor

Samsung Medical Center

Enrollment

72 participants

Start Date

Nov 13, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • 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 Criteria8

  • 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

Interventions

DEVICEdigital health (application and smartwatch)

The application allows users to conduct self-assessments for managing symptoms and side effects related to treatment. Based on the assessment results, it provides personalized self-management strategies. Additionally, users can access features for exercise, diet, and weight management.


Locations(1)

Samsung Medical Center

Seoul, Republic of Korea, South Korea

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NCT06729684


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