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NCT03072966 Clinical Trial

Development of Distress Management Algorithms Using Mobile Device Based Health Logs in Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:
Development of Distress Management Algorithms Using Mobile Device Based Health Logs in Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03072966
Other study ID # S2016-1188-0004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 13, 2017
Est. completion date December 31, 2018

Study information
Verified date January 2019
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date December 31, 2018
Est. primary completion date October 31, 2018
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria:

- Stage 0-III breast cancer

Exclusion Criteria:

- Stage IV breast cancer

- Breast cancer recurrence or metastasis

- Severe medical illness

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Wearable device (Fitbit Charge HR® or Fitbit Alta ®)
Physical activities will be monitored by wearable device.

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul Korea

Sponsors (1)
Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 6months
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