Breast CancerDRAAGONNCT03783481
Distress Reduction by Activity Tracking and Activity Enhancement by Mobile Support Group in Oncology
A study testing Mobile community and No Mobile community in people with Breast Cancer and Mobile Community, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Breast Cancer, Mobile Community
- What is being tested?
- Mobile community and No Mobile community
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jan 2019to 16 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Breast cancer recurrence or metastasis
- Severe medical illness
- need to Adjubant Chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Breast Cancer, Mobile Community
- Being tested
- Mobile community, No Mobile community
- Keywords
- Breast cancer survivors, mobile community, distress
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile communityDevice
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.
No Mobile communityOther
No Mobile community
| Study group | Role | What they receive |
|---|---|---|
| Mobile community group | Experimental | join the mobile community via the smartphone application Receives: Device: Mobile community |
| No community group | Active comparator | Not described Receives: Other: No Mobile community |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of moderate to severe distress at 6 months
Using distress thermometer collected by smartphone application based questionnaire
Measured: 6months
Secondary outcomes (1)
total weekly steps at 6 months
the total number of weekly steps collected by smartphone application
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start7 Jan 2019
- Primary completion17 Apr 2020
- Study completion16 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Il Yong Chung, Asan Medical Center
- Investigators
- Il Yong Chung, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783481
- Sponsor's protocol ID
- S2018-2450-0001
- Acronym
- DRAAGON
- Status last verified
- Jan 2021
- First submitted
- 17 Dec 2018
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jung M, Lee SB, Lee JW, Park YR, Chung H, Min YH, Park HJ, Lee M, Chung S, Son BH, Ahn SH, Chung IY. The Impact of a Mobile Support Group on Distress and Physical Activity in Breast Cancer Survivors: Randomized, Parallel-Group, Open-Label, Controlled Trial. J Med Internet Res. 2023 Aug 7;25:e47158. doi: 10.2196/47158.
PubMed 37549004
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distress Reduction by Activity Tracking and Activity Enhancement by Mobile Support Group in Oncology
- ClinicalTrials.gov ID
- NCT03783481
- Acronym / sponsor ID
- DRAAGON / S2018-2450-0001
- Conditions
- Breast Cancer, Mobile Community
- Keywords
- Breast cancer survivors, mobile community, distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 17 Apr 2020 (actual)
- Study completion
- 16 Nov 2020 (actual)
- First posted
- 21 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile community group | Experimental | Device: Mobile communityjoin the mobile community via the smartphone application |
| No community group | Active comparator | Other: No Mobile community |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Breast cancer recurrence or metastasis
- Severe medical illness
- need to Adjubant Chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile communityInstall 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. | Device | Mobile community group |
| No Mobile communityNo Mobile community | Other | No community group |
Primary outcome
Rate of moderate to severe distress at 6 months
Time frame: 6months
Using distress thermometer collected by smartphone application based questionnaire
1 secondary outcome
total weekly steps at 6 months
Time frame: 6months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Derived from this study: PubMed 37549004Jung M, Lee SB, Lee JW, Park YR, Chung H, Min YH, Park HJ, Lee M, Chung S, Son BH, Ahn SH, Chung IY. The Impact of a Mobile Support Group on Distress and Physical Activity in Breast Cancer Survivors: Randomized, Parallel-Group, Open-Label, Controlled Trial. J Med Internet Res. 2023 Aug 7;25:e47158. doi: 10.2196/47158.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Il Yong Chung principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile community and No Mobile community in people with Breast Cancer and Mobile Community, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of moderate to severe distress at 6 months (time frame: 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03783481, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.