Development of Distress Management Algorithms Using Mobile Device Based Health Logs in Breast Cancer Survivors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Asan Medical Center
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Efficacy of distress screening of wearable device
Study Overview
Brief Summary
Distress monitoring is an important issue in cancer survivors. However, conventional distress screening is very difficult to perform. This study investigates the efficacy of wearable device as a tool of distress monitoring in breast cancer survivors.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Stage 0-III breast cancer
Exclusion Criteria
- •Stage IV breast cancer
- •Breast cancer recurrence or metastasis
- •Severe medical illness
Arms & Interventions
Distress screening group
Physical activities will be monitored by wearable device. Patient-reported outcomes including distress, depression, physical activities and quality of life are going to be collected by questionnaires based on smartphone application and paper. The algorithm of distress screening will be developed with the analysis of patterns of physical activities.
Intervention: Wearable device (Fitbit Charge HR® or Fitbit Alta ®) (Device)
Outcomes
Primary Outcomes
Efficacy of distress screening of wearable device
Time Frame: 6months
The results of distress screening questionnaire and patterns of physical activities are going to be compared. The association between those two data will be analyzed. Using data of physical activities, the prediction model of distress will be tested and validated.
Secondary Outcomes
No secondary outcomes reported
Investigators
Il Yong Chung
Clinical Assistant Professor
Asan Medical Center