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

NCT03072966 | Completed

• 1 other identifier: S2016-1188-0004
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Quality of Life

Keywords

Distress; Exercise; Wearable device; Smartphone

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Distress screening group

EXPERIMENTAL

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.

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

Interventions

Wearable device (Fitbit Charge HR® or Fitbit Alta ®) DEVICE

Physical activities will be monitored by wearable device.

Distress screening group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Stage 0-III breast cancer

You may not qualify if:

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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, Korea, 05505, South Korea

Location

Related Publications (3)

• 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.

  PMID: 32364508 DERIVED

• 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.

  PMID: 31998651 DERIVED

• 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.

  PMID: 31493319 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: March 8, 2017
• Study Start: June 13, 2017
• Primary Completion: October 31, 2018
• Study Completion: December 31, 2018
• Last Updated: January 10, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)