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

NCT ID: NCT03072966

Last Updated: 2019-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-13

Study Completion Date

2018-12-31

Brief Summary

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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

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Conditions

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Breast Cancer Quality of Life

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Distress screening group

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.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

Physical activities will be monitored by wearable device.

Interventions

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

Physical activities will be monitored by wearable device.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Stage 0-III breast cancer

Exclusion Criteria

* Stage IV breast cancer
* Breast cancer recurrence or metastasis
* Severe medical illness
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Il Yong Chung

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Asan Medical Center

Seoul, Korea, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 32364508 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31998651 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31493319 (View on PubMed)

Other Identifiers

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S2016-1188-0004

Identifier Type: -

Identifier Source: org_study_id

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