Breast CancerNCT03190720
Development of Exercise Promotion Program Using a Mobile Community
A study testing Mobile community in people with Breast Cancer and Physical Activity, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Breast Cancer, Physical Activity
- What is being tested?
- Mobile community
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jan 2018to 31 Dec 2018
- 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
Who cannot join
- Stage IV breast cancer
- Breast cancer recurrence or metastasis
- Severe medical illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Exercise Promotion Program Using a Mobile Community Based on a Smart Phone Application in Breast Cancer Survivors
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.
- Conditions
- Breast Cancer, Physical Activity
- Being tested
- Mobile community
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile communityDevice
A mobile community based on smartphone application (WalkOn) which gives participants to information about their own steps and others'.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Community First | Experimental | Participants will be registered to a mobile community at first. After 6 weeks, They will leave the mobile community. Receives: 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. Receives: Device: Mobile community |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distress
Assessment using Patient Health Questionnaire (PHQ-9)
Measured: up to 3months
Secondary outcomes (1)
Physical activity
Assessment using International Physical Activity Questionnaire (IPAQ)
Measured: up to 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start30 Jan 2018
- Primary completion31 Oct 2018
- Study completion31 Dec 2018
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- two different single-arm study
- Masking
- None (open label)
- Enrolment
- 64 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190720
- Sponsor's protocol ID
- 2017-0328
- Status last verified
- Jan 2019
- First submitted
- 12 Jun 2017
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31998651
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Exercise Promotion Program Using a Mobile Community Based on a Smart Phone Application in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT03190720
- Acronym / sponsor ID
- 2017-0328
- Conditions
- Breast Cancer, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 19 Jun 2017 (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 a mobile community based on a smart phone application to enhance physical activities of breast cancer survivors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two different single-arm study
| Arm | Type | Receives |
|---|---|---|
| Mobile Community First | Experimental | Device: Mobile communityParticipants will be registered to a mobile community at first. After 6 weeks, They will leave the mobile community. |
| Mobile Community Later | Experimental | Device: Mobile communityParticipants will not be registered to a mobile community at first. After 6 weeks, They will be registered to the mobile community. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Stage 0-III breast cancer
Key exclusion criteria (3 listed)
- Stage IV breast cancer
- Breast cancer recurrence or metastasis
- Severe medical illness
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 communityA mobile community based on smartphone application (WalkOn) which gives participants to information about their own steps and others'. | Device | Mobile Community First, Mobile Community Later |
Primary outcome
Distress
Time frame: up to 3months
Assessment using Patient Health Questionnaire (PHQ-9)
1 secondary outcome
Physical activity
Time frame: up to 3months
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 10 Jan 2019.
- Derived from this study: PubMed 31998651Chung 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Breast Cancer and Physical Activity, 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 1 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 10 Jan 2019. 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?
Distress (time frame: up to 3months). 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 NCT03190720, 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 10 Jan 2019.