Back to resultsEffects on the Personalized Rehabilitation Service in Patients With Cancer
Primary Purpose
Breast Cancer, Breast Neoplasms, Breast Cancer Female
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Personalized health care service
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
Eligibility Criteria
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 cannot participate rehabilitation exercise program
Sites / Locations
- Seoul national university bundang hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Personalized rehabilitation service group
Conventional group
Arm Description
Breast cancer patients who use mobile healthcare service application and receive personal feedback from clinician
Breast cancer patients with conventional care
Outcomes
Primary Outcome Measures
Patient health ability change
Measuring Health and Disability WHODAS 2.0
Secondary Outcome Measures
Lab test result change
Laboratory test (Blood test)
Patient satisfaction change on mobile service
Patient subjective evaluation by survey on satisfaction
Patient satisfaction change on healthcare management
Patient subjective evaluation by survey on satisfaction
Full Information
NCT ID
NCT03200067
First Posted
June 20, 2017
Last Updated
June 25, 2017
Sponsor
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03200067
Brief Title
Effects on the Personalized Rehabilitation Service in Patients With Cancer
Official Title
Effects on the Personalized Rehabilitation Service in Patients With Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 3, 2017 (Actual)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Neoplasms, Breast Cancer Female, Lymphedema
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Personalized rehabilitation service group
Arm Type
Experimental
Arm Description
Breast cancer patients who use mobile healthcare service application and receive personal feedback from clinician
Arm Title
Conventional group
Arm Type
No Intervention
Arm Description
Breast cancer patients with conventional care
Intervention Type
Behavioral
Intervention Name(s)
Personalized health care service
Intervention Description
Personalized health care service, such as rehabilitation exercise recommendation, lifestyle activity coaching, health data monitoring
Primary Outcome Measure Information:
Title
Patient health ability change
Description
Measuring Health and Disability WHODAS 2.0
Time Frame
Baseline and after 4 weeks, 8 weeks of lifestyle modification
Secondary Outcome Measure Information:
Title
Lab test result change
Description
Laboratory test (Blood test)
Time Frame
Baseline and after 4 weeks, 8 weeks of lifestyle modification
Title
Patient satisfaction change on mobile service
Description
Patient subjective evaluation by survey on satisfaction
Time Frame
Baseline and after 4 weeks, 8 weeks of lifestyle modification
Title
Patient satisfaction change on healthcare management
Description
Patient subjective evaluation by survey on satisfaction
Time Frame
Baseline and after 4 weeks, 8 weeks of lifestyle modification
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 cannot participate rehabilitation exercise program
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Borim Ryu, MS
Phone
+821041417040
Email
borim@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eunjoo Yang, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul national university bundang hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Borim Ryu, MS
Phone
+82317878983
Email
borim@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Eunjoo Yang, PhD
Phone
+82317877734
Email
graceloves@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects on the Personalized Rehabilitation Service in Patients With Cancer
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