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

Not Applicable

Completed

• Conditions: Quality of Life; Breast Cancer
• Interventions: Device: Wearable device (Fitbit Charge HR® or Fitbit Alta ®)

• Registration Number: NCT03072966
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-23
• Study First Submitted QC: 2017-03-07
• Study First Posted: 2017-03-08
• Study Start: 2017-06-13
• Primary Completion: 2018-10-31
• Study Completion: 2018-12-31
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

• Stage 0-III breast cancer

Read More

Exclusion Criteria

• Stage IV breast cancer
• Breast cancer recurrence or metastasis
• Severe medical illness

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Distress screening group	Wearable device (Fitbit Charge HR® or Fitbit Alta ®)	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.

Primary Outcome Measures

Name	Time	Method
Efficacy of distress screening of wearable device	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.

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Korea, Republic of