Breast CancerNCT03194399
Development of Personalized Health Care Service in Patients With Breast Cancer
A study testing Personalized health care service in people with Breast Cancer and Lymphedema, run by Seoul National University Bundang Hospital.
Trial summary
In order to develop effective personalized healthcare service program for breast cancer rehabilitation, we designed this study using mobile phone and clinical intervention(feedback coaching). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Lymphedema, Cancer-related Problem/Condition
- 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
- 11 participants
- Where
- No sites listed yet
- Study dates
- 27 Nov 2015to 22 Feb 2016
- 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 Any age
- Women only
- No healthy volunteers
- Child, 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 can not participate rehabilitation exercise program
About this study
In order to develop effective personalized healthcare service program for breast cancer rehabilitation, we designed this study using mobile phone and clinical intervention(feedback coaching).
- Conditions
- Breast Cancer, Lymphedema, Cancer-related Problem/Condition
- 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
Physical activity coaching, other functional outcome observation
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients | Experimental | Not described Receives: Behavioral: Personalized health care service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction change
Patient subjective evaluation by survey on satisfaction
Measured: Baseline and after 2 weeks, 4 weeks of lifestyle modification
Secondary outcomes (3)
Physical activity change
Physical activity measurement by step count
Measured: Baseline and after 2 weeks, 4 weeks of lifestyle modification
Functional outcome change
(Physical)Functional outcome measurement by breast cancer patient questionnaire
Measured: Baseline and after 2 weeks, 4 weeks of lifestyle modification
Quality of care change
Quality of care measurement by breast cancer patient questionnaire
Measured: Baseline and after 2 weeks, 4 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 posted21 Jun 2017
- Study start27 Nov 2015
- Primary completion15 Feb 2016
- Study completion22 Feb 2016
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
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
- NCT03194399
- Sponsor's protocol ID
- E-1509-314-002
- Status last verified
- Jun 2017
- First submitted
- 7 Jun 2017
- Last updated
- 21 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 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Personalized Health Care Service in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT03194399
- Acronym / sponsor ID
- E-1509-314-002
- Conditions
- Breast Cancer, Lymphedema, Cancer-related Problem/Condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 27 Nov 2015 (actual)
- Primary completion
- 15 Feb 2016 (actual)
- Study completion
- 22 Feb 2016 (actual)
- First posted
- 21 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 develop effective personalized healthcare service program for breast cancer rehabilitation, we designed this study using mobile phone and clinical intervention(feedback coaching).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients | Experimental | Behavioral: Personalized health care service |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 can not 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 servicePhysical activity coaching, other functional outcome observation | Behavioural | Breast cancer patients |
Primary outcome
Patient satisfaction change
Time frame: Baseline and after 2 weeks, 4 weeks of lifestyle modification
Patient subjective evaluation by survey on satisfaction
3 secondary outcomes
Physical activity change
Time frame: Baseline and after 2 weeks, 4 weeks of lifestyle modification
Functional outcome change
Time frame: Baseline and after 2 weeks, 4 weeks of lifestyle modification
Quality of care change
Time frame: Baseline and after 2 weeks, 4 weeks of lifestyle modification
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 21 Jun 2017.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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
Questions about this trial
What is this clinical trial studying?
A study testing Personalized health care service in people with Breast Cancer and Lymphedema, run by Seoul National University Bundang Hospital.
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: finished, as of the sponsor's last update on 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Patient satisfaction change (time frame: Baseline and after 2 weeks, 4 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 21 Jun 2017.