Distress Reduction by Activity Tracking and Activity Enhancement by Mobile Support Group in Oncology (DRAAGON)

January 12, 2021 updated by: Il Yong Chung, Asan Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobile community group
join the mobile community via the smartphone application
Device: Mobile community
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.
Active Comparator: No community group
Other: No Mobile community
No Mobile community

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of moderate to severe distress at 6 months
Time Frame: 6months
Using distress thermometer collected by smartphone application based questionnaire
6months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total weekly steps at 6 months
Time Frame: 6months
the total number of weekly steps collected by smartphone application
6months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Il Yong Chung, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2019

Primary Completion (Actual)

April 17, 2020

Study Completion (Actual)

November 16, 2020

Study Registration Dates

First Submitted

December 17, 2018

First Submitted That Met QC Criteria

December 19, 2018

First Posted (Actual)

December 21, 2018

Study Record Updates

Last Update Posted (Actual)

January 13, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2018-2450-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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