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Effects on the Personalized Rehabilitation Service in Patients With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03200067
Recruitment Status : Unknown
Verified June 2017 by Eun Joo Yang, Seoul National University Bundang Hospital.
Recruitment status was:  Recruiting
First Posted : June 27, 2017
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Eun Joo Yang, Seoul National University Bundang Hospital

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).

Condition or disease Intervention/treatment Phase
Breast Cancer Breast Neoplasms Breast Cancer Female Lymphedema Behavioral: Personalized health care service Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects on the Personalized Rehabilitation Service in Patients With Cancer
Actual Study Start Date : June 3, 2017
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Personalized rehabilitation service group
Breast cancer patients who use mobile healthcare service application and receive personal feedback from clinician
Behavioral: Personalized health care service
Personalized health care service, such as rehabilitation exercise recommendation, lifestyle activity coaching, health data monitoring

No Intervention: Conventional group
Breast cancer patients with conventional care



Primary Outcome Measures :
  1. Patient health ability change [ Time Frame: Baseline and after 4 weeks, 8 weeks of lifestyle modification ]
    Measuring Health and Disability WHODAS 2.0


Secondary Outcome Measures :
  1. Lab test result change [ Time Frame: Baseline and after 4 weeks, 8 weeks of lifestyle modification ]
    Laboratory test (Blood test)

  2. Patient satisfaction change on mobile service [ Time Frame: Baseline and after 4 weeks, 8 weeks of lifestyle modification ]
    Patient subjective evaluation by survey on satisfaction

  3. Patient satisfaction change on healthcare management [ Time Frame: Baseline and after 4 weeks, 8 weeks of lifestyle modification ]
    Patient subjective evaluation by survey on satisfaction



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200067


Contacts
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Contact: Borim Ryu, MS +821041417040 borim@snu.ac.kr

Locations
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Korea, Republic of
Seoul national university bundang hospital Recruiting
Seongnam, Gyeonggi, Korea, Republic of, 13620
Contact: Borim Ryu, MS    +82317878983    borim@snu.ac.kr   
Contact: Eunjoo Yang, PhD    +82317877734    graceloves@gmail.com   
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
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Study Chair: Eunjoo Yang, PhD Seoul National University Bundang Hospital
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Responsible Party: Eun Joo Yang, Study chair, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03200067    
Other Study ID Numbers: B-1705/395-302
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases