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

Samsung Medical Center

Status: Enrolling

Conditions: Breast Cancer; Breast Cancer Survivorship; Digital Health

Treatments: Device: digital health (application and smartwatch)

Study type: Interventional

Funder types: Other

Identifiers

NCT06729684

SMC 2023-10-048-010

HA23C0423 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

control (Conventional Treatment)

No Intervention group

Description:

* breast cancer surgery with CTx/RTx/HTx * brochure training

intervention (digital health)

Experimental group

Description:

* breast cancer surgery with CTx/RTx/HTx * brochure training * add digital health (application + smartwatch)

Treatment:

Device: digital health (application and smartwatch)