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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer Survivorship
- Sponsor
- Samsung Medical Center
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- PROMIS29
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
JiHye Hwang
Professor
Samsung Medical Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
PROMIS29
Time Frame: Baseline, Month 1, Month 3, Month 6
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.
Secondary Outcomes
- EQ-5D-5L(Baseline, Month 1, Month 3, Month 6)
- PRO-CTCAE(Month 1, Month 3, Month 6)
- ICF (International Classification of Functioning, Disability, and Health)(Baseline, Month 1, Month 3, Month 6)
- Activity (step count)(Baseline, Month 1, Month 3, Month 6)
- TTM (Transtheoretical Model)(Baseline, Month 3, Month 6)
- OBQ-K(Baseline, Month 3, Month 6)
- CBI-K(Baseline, Month 3, Month 6)
- body composition (inbody)(Baseline, Month 1, Month 3, Month 6)