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.
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 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
Parallel
digital health (application and smartwatch)
DeviceThe 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.
PROMIS29
Full Title: Patient-Reported Outcomes Measurement Information System Objective: health related quality of life Scoring System: Each item is rated on a scale of 1 to 5. Lower scores indicate better health for pain, depression, anxiety, and fatigue, while higher scores indicate better health for physical function, social roles, and activities, and sleep disorders.
EQ-5D-5L
Full Title: EuroQol 5-Dimension 5-level Objective: quality of life Scoring System: Each item is evaluated on a 5-point scale and weighted according to the country. EQ VAS evaluates data on a scale of 0-100, with a higher score indicating better health.
PRO-CTCAE
Full Title: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events Objective: Clinical symptoms and adverse effects reported by patients Scoring System: Evaluate the frequency, severity, interference with daily activities, amount, and presence/absence of side effects over the past 7 days.
ICF (International Classification of Functioning, Disability, and Health)
Full Title: International Classification of Functioning, Disability and Health Objective: function, activity and participant, environment Scoring System: A. Assess the 8 items of body functions, 8 items of activities and participation, and 8 items of environmental factors of the breast cancer ICF core set brief B. Body functions are assessed as 0 (no problems) - 4 (extreme problems), 9 (not applicable). Activities and participation are assessed as 0 (no difficulties) - 4 (extreme difficulties), 9 (not applicable). Environment is assessed as 0 (no barriers) - 4 (extreme barriers), +0 (no facilitating factors) - +4 (complete facilitating factors), 9 (not applicable).
Activity (step count)
Objective: Number of steps taken in the past month Scoring System: Number of steps measured by mobile phone
SUS
Full Title: System Usability Scale Objective: System Usability Scoring System: A. 10 questions, 5-point scale B. Total = ((sum of odd questions - 5) + (25 - sum of even questions)) \* 2.5 C. Score range is 0-100, and the benchmark is known to be 68 points.
satisfaction survey
Objective: Check app satisfaction and suggestions/issues Scoring system: A. Self-administered questionnaire b. Use a semi-structured survey to assess app satisfaction and gather suggestions/issues.
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Samsung Medical Center
Lead sponsor
Pusan National University Yangsan Hospital
Collaborator
