Breast CancerNCT03072966
Development of Distress Management Algorithms Using Mobile Device Based Health Logs in Breast Cancer Survivors
A study testing Wearable device (Fitbit Charge HR® or Fitbit Alta ®) in people with Breast Cancer and Quality of Life, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Distress monitoring is an important issue in cancer survivors. However, conventional distress screening is very difficult to perform. This study investigates the efficacy of wearable device as a tool of distress monitoring in 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, Quality of Life
- What is being tested?
- Wearable device (Fitbit Charge HR® or Fitbit Alta ®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jun 2017to 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
Distress monitoring is an important issue in cancer survivors. However, conventional distress screening is very difficult to perform. This study investigates the efficacy of wearable device as a tool of distress monitoring in breast cancer survivors.
- Conditions
- Breast Cancer, Quality of Life
- Being tested
- Wearable device (Fitbit Charge HR® or Fitbit Alta ®)
- Keywords
- Distress, Exercise, Wearable device, Smartphone
- 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.
Wearable device (Fitbit Charge HR® or Fitbit Alta ®)Device
Physical activities will be monitored by wearable device.
| Study group | Role | What they receive |
|---|---|---|
| Distress screening group | Experimental | Physical activities will be monitored by wearable device. Patient-reported outcomes including distress, depression, physical activities and quality of life are going to be collected by questionnaires based on smartphone application and paper. The algorithm of distress screening will be developed with the analysis of patterns of physical activities. Receives: Device: Wearable device (Fitbit Charge HR® or Fitbit Alta ®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of distress screening of wearable device
The results of distress screening questionnaire and patterns of physical activities are going to be compared. The association between those two data will be analyzed. Using data of physical activities, the prediction model of distress will be tested and validated.
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start13 Jun 2017
- 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 (3)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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 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
- NCT03072966
- Sponsor's protocol ID
- S2016-1188-0004
- Status last verified
- Jan 2019
- First submitted
- 23 Feb 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
Jung M, Lee S, Kim J, Kim H, Ko B, Son BH, Ahn SH, Park YR, Cho D, Chung H, Park HJ, Lee M, Lee JW, Chung S, Chung IY. A Mobile Technology for Collecting Patient-Reported Physical Activity and Distress Outcomes: Cross-Sectional Cohort Study. JMIR Mhealth Uhealth. 2020 May 4;8(5):e17320. doi: 10.2196/17320.
PubMed 32364508Chung 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 31998651Chung IY, Jung M, Lee SB, Lee JW, Park YR, Cho D, Chung H, Youn S, Min YH, Park HJ, Lee M, Chung S, Son BH, Ahn SH. An Assessment of Physical Activity Data Collected via a Smartphone App and a Smart Band in Breast Cancer Survivors: Observational Study. J Med Internet Res. 2019 Sep 6;21(9):13463. doi: 10.2196/13463.
PubMed 31493319
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 Distress Management Algorithms Using Mobile Device Based Health Logs in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT03072966
- Acronym / sponsor ID
- S2016-1188-0004
- Conditions
- Breast Cancer, Quality of Life
- Keywords
- Distress, Exercise, Wearable device, Smartphone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 13 Jun 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 8 Mar 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.
Distress monitoring is an important issue in cancer survivors. However, conventional distress screening is very difficult to perform. This study investigates the efficacy of wearable device as a tool of distress monitoring in breast cancer survivors.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Distress screening group | Experimental | Device: Wearable device (Fitbit Charge HR® or Fitbit Alta ®)Physical activities will be monitored by wearable device. Patient-reported outcomes including distress, depression, physical activities and quality of life are going to be collected by questionnaires based on smartphone application and paper. The algorithm of distress screening will be developed with the analysis of patterns of physical activities. |
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 |
|---|---|---|
| Wearable device (Fitbit Charge HR® or Fitbit Alta ®)Physical activities will be monitored by wearable device. | Device | Distress screening group |
Primary outcome
Efficacy of distress screening of wearable device
Time frame: 6months
The results of distress screening questionnaire and patterns of physical activities are going to be compared. The association between those two data will be analyzed. Using data of physical activities, the prediction model of distress will be tested and validated.
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 32364508Jung M, Lee S, Kim J, Kim H, Ko B, Son BH, Ahn SH, Park YR, Cho D, Chung H, Park HJ, Lee M, Lee JW, Chung S, Chung IY. A Mobile Technology for Collecting Patient-Reported Physical Activity and Distress Outcomes: Cross-Sectional Cohort Study. JMIR Mhealth Uhealth. 2020 May 4;8(5):e17320. doi: 10.2196/17320.
- 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.
- Derived from this study: PubMed 31493319Chung IY, Jung M, Lee SB, Lee JW, Park YR, Cho D, Chung H, Youn S, Min YH, Park HJ, Lee M, Chung S, Son BH, Ahn SH. An Assessment of Physical Activity Data Collected via a Smartphone App and a Smart Band in Breast Cancer Survivors: Observational Study. J Med Internet Res. 2019 Sep 6;21(9):13463. doi: 10.2196/13463.
- 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 Wearable device (Fitbit Charge HR® or Fitbit Alta ®) in people with Breast Cancer and Quality of Life, 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?
Efficacy of distress screening of wearable device (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 NCT03072966, which also lists 3 linked publications.
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.