NCT03190720

Brief Summary

This study aims to investigate the effect of a mobile community based on a smart phone application to enhance physical activities of breast cancer survivors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 19, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

January 30, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

9 months

First QC Date

June 12, 2017

Last Update Submit

January 8, 2019

Conditions

Breast CancerPhysical Activity

Outcome Measures

Primary Outcomes (1)

  • Distress

    Assessment using Patient Health Questionnaire (PHQ-9)

    up to 3months

Secondary Outcomes (1)

  • Physical activity

    up to 3months

Study Arms (2)

Mobile Community First

EXPERIMENTAL

Participants will be registered to a mobile community at first. After 6 weeks, They will leave the mobile community.

Device: Mobile community

Mobile Community Later

EXPERIMENTAL

Participants will not be registered to a mobile community at first. After 6 weeks, They will be registered to the mobile community.

Device: Mobile community

Interventions

Mobile communityDEVICE

A mobile community based on smartphone application (WalkOn) which gives participants to information about their own steps and others'.

Mobile Community FirstMobile Community Later

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Korea, 05505, South Korea

Location

Related Publications (1)

  • 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: 31998651DERIVED

MeSH Terms

Conditions

Breast NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: two different single-arm study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

June 12, 2017

First Posted

June 19, 2017

Study Start

January 30, 2018

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)