Development and Validation of a Personalized Digital Healthcare Model for Managing Side Effects in Breast Cancer Survivors
Recruiting · NCT06729684 · Interventional (participants receive a specific treatment) · Lead sponsor: Samsung Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
digital health (application and smartwatch)
What this trial is 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.
Who can take part
Age range
18 Years to 65 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Samsung Medical Center - Seoul, Republic of Korea, South Korea