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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorSamsung Medical Center

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

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

Trial design

Treatments tested in this trial

  • digital health (application and smartwatch)

Treatment groups

72 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Samsung Medical Center

Lead sponsor

Pusan National University Yangsan Hospital

Collaborator