Back to resultsDevelopment of Exercise Promotion Program Using a Mobile Community
Primary Purpose
Breast Cancer, Physical Activity
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mobile community
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Stage 0-III breast cancer
Exclusion Criteria:
- Stage IV breast cancer
- Breast cancer recurrence or metastasis
- Severe medical illness
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Mobile Community First
Mobile Community Later
Arm Description
Participants will be registered to a mobile community at first. After 6 weeks, They will leave the mobile community.
Participants will not be registered to a mobile community at first. After 6 weeks, They will be registered to the mobile community.
Outcomes
Primary Outcome Measures
Distress
Assessment using Patient Health Questionnaire (PHQ-9)
Secondary Outcome Measures
Physical activity
Assessment using International Physical Activity Questionnaire (IPAQ)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03190720
Brief Title
Development of Exercise Promotion Program Using a Mobile Community
Official Title
Development of Exercise Promotion Program Using a Mobile Community Based on a Smart Phone Application in Breast Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 30, 2018 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Physical Activity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two different single-arm study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobile Community First
Arm Type
Experimental
Arm Description
Participants will be registered to a mobile community at first. After 6 weeks, They will leave the mobile community.
Arm Title
Mobile Community Later
Arm Type
Experimental
Arm Description
Participants will not be registered to a mobile community at first. After 6 weeks, They will be registered to the mobile community.
Intervention Type
Device
Intervention Name(s)
Mobile community
Intervention Description
A mobile community based on smartphone application (WalkOn) which gives participants to information about their own steps and others'.
Primary Outcome Measure Information:
Title
Distress
Description
Assessment using Patient Health Questionnaire (PHQ-9)
Time Frame
up to 3months
Secondary Outcome Measure Information:
Title
Physical activity
Description
Assessment using International Physical Activity Questionnaire (IPAQ)
Time Frame
up to 3months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage 0-III breast cancer
Exclusion Criteria:
Stage IV breast cancer
Breast cancer recurrence or metastasis
Severe medical illness
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Korea
ZIP/Postal Code
05505
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31998651
Citation
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.
Results Reference
derived
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Development of Exercise Promotion Program Using a Mobile Community
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