Breast CancerNCT03200067
Effects on the Personalized Rehabilitation Service in Patients With Cancer
A study testing Personalized health care service in people with Breast Cancer and Breast Neoplasms, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
In order to study the effectiveness of personalized healthcare service program for breast cancer rehabilitation, investigators designed this study using mobile phone and clinical intervention(feedback coaching). Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasms, Breast Cancer Female
- What is being tested?
- Personalized health care service
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jun 2017to Sep 2017
- 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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer patient (age over 18), Cancer stage under 3, Android OS smartphone user
Who cannot join
- Cancer stage over 4, Patients diagnosed with multiple cancer, Patient who cannot participate rehabilitation exercise program
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul national university bundang hospital
Seongnam-si, Gyeonggi-do, 13620
Borim Ryu, MS, +82317878983, borim@snu.ac.kr
Eunjoo Yang, PhD, +82317877734, graceloves@gmail.com
About this study
In order to study the effectiveness of personalized healthcare service program for breast cancer rehabilitation, investigators designed this study using mobile phone and clinical intervention(feedback coaching).
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Cancer Female, Lymphedema
- Being tested
- Personalized health care service
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized health care serviceBehavioural
Personalized health care service, such as rehabilitation exercise recommendation, lifestyle activity coaching, health data monitoring
| Study group | Role | What they receive |
|---|---|---|
| Personalized rehabilitation service group | Experimental | Breast cancer patients who use mobile healthcare service application and receive personal feedback from clinician Receives: Behavioral: Personalized health care service |
| Conventional group | No intervention | Breast cancer patients with conventional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient health ability change
Measuring Health and Disability WHODAS 2.0
Measured: Baseline and after 4 weeks, 8 weeks of lifestyle modification
Secondary outcomes (3)
Lab test result change
Laboratory test (Blood test)
Measured: Baseline and after 4 weeks, 8 weeks of lifestyle modification
Patient satisfaction change on mobile service
Patient subjective evaluation by survey on satisfaction
Measured: Baseline and after 4 weeks, 8 weeks of lifestyle modification
Patient satisfaction change on healthcare management
Patient subjective evaluation by survey on satisfaction
Measured: Baseline and after 4 weeks, 8 weeks of lifestyle modification
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start3 Jun 2017
- Primary completionAug 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Joo Yang, Seoul National University Bundang Hospital
- Investigators
- Eunjoo Yang, PhD, Study chair, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200067
- Sponsor's protocol ID
- B-1705/395-302
- Status last verified
- Jun 2017
- First submitted
- 20 Jun 2017
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on the Personalized Rehabilitation Service in Patients With Cancer
- ClinicalTrials.gov ID
- NCT03200067
- Acronym / sponsor ID
- B-1705/395-302
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Cancer Female, Lymphedema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 3 Jun 2017 (actual)
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 27 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.
In order to study the effectiveness of personalized healthcare service program for breast cancer rehabilitation, investigators designed this study using mobile phone and clinical intervention(feedback coaching).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized rehabilitation service group | Experimental | Behavioral: Personalized health care serviceBreast cancer patients who use mobile healthcare service application and receive personal feedback from clinician |
| Conventional group | No intervention | –Breast cancer patients with conventional care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Breast cancer patient (age over 18), Cancer stage under 3, Android OS smartphone user
Key exclusion criteria (1 listed)
- Cancer stage over 4, Patients diagnosed with multiple cancer, Patient who cannot participate rehabilitation exercise program
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 |
|---|---|---|
| Personalized health care servicePersonalized health care service, such as rehabilitation exercise recommendation, lifestyle activity coaching, health data monitoring | Behavioural | Personalized rehabilitation service group |
Primary outcome
Patient health ability change
Time frame: Baseline and after 4 weeks, 8 weeks of lifestyle modification
Measuring Health and Disability WHODAS 2.0
3 secondary outcomes
Lab test result change
Time frame: Baseline and after 4 weeks, 8 weeks of lifestyle modification
Patient satisfaction change on mobile service
Time frame: Baseline and after 4 weeks, 8 weeks of lifestyle modification
Patient satisfaction change on healthcare management
Time frame: Baseline and after 4 weeks, 8 weeks of lifestyle modification
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- 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.
Eunjoo Yang, PhD study chair
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized health care service in people with Breast Cancer and Breast Neoplasms, run by Seoul National University Bundang Hospital 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 1 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: status not confirmed, as of the sponsor's last update on 27 Jun 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Borim Ryu, MS (+821041417040, borim@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient health ability change (time frame: Baseline and after 4 weeks, 8 weeks of lifestyle modification). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2017.