Back to resultsDistress Reduction by Activity Tracking and Activity Enhancement by Mobile Support Group in Oncology (DRAAGON)
Primary Purpose
Breast Cancer, Mobile Community
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mobile community
No Mobile community
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Breast cancer survivors, mobile community, distress
Eligibility Criteria
Inclusion Criteria:
- Stage 0-III breast cancer
- ECOG Performance Status 0
- Patient who underwent surgery for breast cancer
- Patients with their own smartphones and who can use smartphone apps
Exclusion Criteria:
- Breast cancer recurrence or metastasis
- Severe medical illness
- need to Adjubant Chemotherapy
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mobile community group
No community group
Arm Description
join the mobile community via the smartphone application
Outcomes
Primary Outcome Measures
Rate of moderate to severe distress at 6 months
Using distress thermometer collected by smartphone application based questionnaire
Secondary Outcome Measures
total weekly steps at 6 months
the total number of weekly steps collected by smartphone application
Full Information
NCT ID
NCT03783481
First Posted
December 17, 2018
Last Updated
January 12, 2021
Sponsor
Asan Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03783481
Brief Title
Distress Reduction by Activity Tracking and Activity Enhancement by Mobile Support Group in Oncology
Acronym
DRAAGON
Official Title
Distress Reduction by Activity Tracking and Activity Enhancement by Mobile Support Group in Oncology
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
April 17, 2020 (Actual)
Study Completion Date
November 16, 2020 (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 the formation of social networks using smartphones can help increase physical activity and reduce stress in survivors after breast cancer treatment surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Mobile Community
Keywords
Breast cancer survivors, mobile community, distress
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobile community group
Arm Type
Experimental
Arm Description
join the mobile community via the smartphone application
Arm Title
No community group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Mobile community
Intervention Description
Install an application (app) on subjects' smartphone. Subject's will join the mobile community using the application through which they can check their own and other members daily steps and communicate with each other.
Intervention Type
Other
Intervention Name(s)
No Mobile community
Intervention Description
No Mobile community
Primary Outcome Measure Information:
Title
Rate of moderate to severe distress at 6 months
Description
Using distress thermometer collected by smartphone application based questionnaire
Time Frame
6months
Secondary Outcome Measure Information:
Title
total weekly steps at 6 months
Description
the total number of weekly steps collected by smartphone application
Time Frame
6months
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
ECOG Performance Status 0
Patient who underwent surgery for breast cancer
Patients with their own smartphones and who can use smartphone apps
Exclusion Criteria:
Breast cancer recurrence or metastasis
Severe medical illness
need to Adjubant Chemotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Il Yong Chung
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
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
Learn more about this trial
Distress Reduction by Activity Tracking and Activity Enhancement by Mobile Support Group in Oncology
We'll reach out to this number within 24 hrs