Back to resultsDevelopment of Distress Management Algorithms Using Mobile Device Based Health Logs in Breast Cancer Survivors
Primary Purpose
Breast Cancer, Quality of Life
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Wearable device (Fitbit Charge HR® or Fitbit Alta ®)
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring Distress, Exercise, Wearable device, Smartphone
Eligibility Criteria
Inclusion Criteria:
- Stage 0-III breast cancer
Exclusion Criteria:
- Stage IV breast cancer
- Breast cancer recurrence or metastasis
- Severe medical illness
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Distress screening group
Arm Description
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.
Outcomes
Primary Outcome Measures
Efficacy of distress screening of wearable device
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 Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03072966
Brief Title
Development of Distress Management Algorithms Using Mobile Device Based Health Logs in Breast Cancer Survivors
Official Title
Development of Distress Management Algorithms Using Mobile Device Based Health Logs in Breast Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 13, 2017 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Quality of Life
Keywords
Distress, Exercise, Wearable device, Smartphone
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Distress screening group
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Wearable device (Fitbit Charge HR® or Fitbit Alta ®)
Intervention Description
Physical activities will be monitored by wearable device.
Primary Outcome Measure Information:
Title
Efficacy of distress screening of wearable device
Description
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.
Time Frame
6months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage 0-III breast cancer
Exclusion Criteria:
Stage IV breast cancer
Breast cancer recurrence or metastasis
Severe medical illness
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Korea
ZIP/Postal Code
05505
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32364508
Citation
Jung M, Lee S, Kim J, Kim H, Ko B, Son BH, Ahn SH, Park YR, Cho D, Chung H, Park HJ, Lee M, Lee JW, Chung S, Chung IY. A Mobile Technology for Collecting Patient-Reported Physical Activity and Distress Outcomes: Cross-Sectional Cohort Study. JMIR Mhealth Uhealth. 2020 May 4;8(5):e17320. doi: 10.2196/17320.
Results Reference
derived
PubMed Identifier
31998651
Citation
Chung IY, Jung M, Park YR, Cho D, Chung H, Min YH, Park HJ, Lee M, Lee SB, Chung S, Son BH, Ahn SH, Lee JW. Exercise Promotion and Distress Reduction Using a Mobile App-Based Community in Breast Cancer Survivors. Front Oncol. 2020 Jan 10;9:1505. doi: 10.3389/fonc.2019.01505. eCollection 2019.
Results Reference
derived
PubMed Identifier
31493319
Citation
Chung IY, Jung M, Lee SB, Lee JW, Park YR, Cho D, Chung H, Youn S, Min YH, Park HJ, Lee M, Chung S, Son BH, Ahn SH. An Assessment of Physical Activity Data Collected via a Smartphone App and a Smart Band in Breast Cancer Survivors: Observational Study. J Med Internet Res. 2019 Sep 6;21(9):13463. doi: 10.2196/13463.
Results Reference
derived
Learn more about this trial
Development of Distress Management Algorithms Using Mobile Device Based Health Logs in Breast Cancer Survivors
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