- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03194399
Development of Personalized Health Care Service in Patients With Breast Cancer
June 20, 2017 updated by: Eun Joo Yang, Seoul National University Bundang Hospital
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Breast cancer patient (age over 18), Cancer stage under 3, Android OS smartphone user
Exclusion Criteria:
- Cancer stage over 4, Patients diagnosed with multiple cancer, Patient who can not participate rehabilitation exercise program
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Breast cancer patients
|
Physical activity coaching, other functional outcome observation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient satisfaction change
Time Frame: Baseline and after 2 weeks, 4 weeks of lifestyle modification
|
Patient subjective evaluation by survey on satisfaction
|
Baseline and after 2 weeks, 4 weeks of lifestyle modification
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity change
Time Frame: Baseline and after 2 weeks, 4 weeks of lifestyle modification
|
Physical activity measurement by step count
|
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
|
(Physical)Functional outcome measurement by breast cancer patient questionnaire
|
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
|
Quality of care measurement by breast cancer patient questionnaire
|
Baseline and after 2 weeks, 4 weeks of lifestyle modification
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Eunjoo Yang, PhD, Seoul National University Bundang Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 27, 2015
Primary Completion (Actual)
February 15, 2016
Study Completion (Actual)
February 22, 2016
Study Registration Dates
First Submitted
June 7, 2017
First Submitted That Met QC Criteria
June 20, 2017
First Posted (Actual)
June 21, 2017
Study Record Updates
Last Update Posted (Actual)
June 21, 2017
Last Update Submitted That Met QC Criteria
June 20, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-1509-314-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.