Actively Recruiting
Development and Validation of Personalized Digital Healthcare Technology and Service Model for Managing Side Effects in Breast Cancer Survivors
Led by Samsung Medical Center · Updated on 2024-12-11
72
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Samsung Medical Center
Lead Sponsor
P
Pusan National University Yangsan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating personalized digital healthcare technologies and self-management strategies for breast cancer survivors who need help managing side effects from treatments like surgery, chemotherapy, radiation, and hormone therapy. The study aims to verify clinical usefulness and develop a service model to meet the diverse healthcare needs of these survivors. This trial is interventional and led by Samsung Medical Center, focusing on improving recovery and management of treatment-related side effects. Participants are randomly assigned to one of two groups: a control group receiving conventional treatment plus brochure training, or an intervention group receiving the same plus digital health tools, including an application and smartwatch. The app helps users self-assess symptoms and side effects and provides personalized self-management strategies along with features for exercise, diet, and weight management. The study includes a six-month period with assessments at baseline, month 1, month 3, and month 6. During the study, participants will complete various evaluations such as the PROMIS29, EQ-5D-5L, PRO-CTCAE, and body composition measurements, among others, at scheduled intervals. Researchers will monitor activity levels via step counts and assess behavioral changes using questionnaires. Safety and adherence are tracked throughout. The total participation lasts six months, with multiple assessments to measure health outcomes and recovery progress.
CONDITIONS
Brief Title
Development and Validation of a Personalized Digital Healthcare Model for Managing Side Effects in Breast Cancer Survivors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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, or visual disabilities that make it difficult to use the application or participate in exercise
- Individuals who undergo delayed breast reconstruction surgery during the study period
- Individuals who develop severe complications or cancer metastasis or recurrence during the study period leading to treatment changes
- Occurrence of a major illness unrelated to study participation
- Failure to comply with the study physician's instructions
- Situations where the participant voluntarily withdraws or cannot continue participating
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants use a digital health application and smartwatch for self-assessment and personalized management of side effects related to breast cancer treatment. They also have access to features for exercise, diet, and weight management.
Visits at Baseline, Month 1, Month 3, and Month 6 for assessments
Trial Site Locations
Total: 1 location
1
Samsung Medical Center
Seoul, Republic of Korea, South Korea, 06351
Actively Recruiting
Research Team
S
Sun Woo Kim, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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