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

Asan Medical Center

Status: Completed

Conditions: Breast Cancer; Quality of Life

Treatments: Device: Wearable device (Fitbit Charge HR® or Fitbit Alta ®)

Study type: Interventional

Funder types: Other

Identifiers

NCT03072966

S2016-1188-0004

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: Female

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stage 0-III breast cancer

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

Distress screening group

Experimental group

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.

Treatment:

Device: Wearable device (Fitbit Charge HR® or Fitbit Alta ®)