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Development of Personalized Health Care Service in Patients With Breast 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: NCT03194399
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):
Eun Joo Yang, Seoul National University Bundang Hospital

Brief 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).

Condition or disease Intervention/treatment Phase
Breast Cancer Lymphedema Cancer-related Problem/Condition Behavioral: Personalized health care service Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Development of Personalized Health Care Service in Patients With Breast Cancer
Actual Study Start Date : November 27, 2015
Actual Primary Completion Date : February 15, 2016
Actual Study Completion Date : February 22, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Breast cancer patients Behavioral: Personalized health care service
Physical activity coaching, other functional outcome observation




Primary Outcome Measures :
  1. Patient satisfaction change [ Time Frame: Baseline and after 2 weeks, 4 weeks of lifestyle modification ]
    Patient subjective evaluation by survey on satisfaction


Secondary Outcome Measures :
  1. Physical activity change [ Time Frame: Baseline and after 2 weeks, 4 weeks of lifestyle modification ]
    Physical activity measurement by step count

  2. Functional outcome change [ Time Frame: Baseline and after 2 weeks, 4 weeks of lifestyle modification ]
    (Physical)Functional outcome measurement by breast cancer patient questionnaire

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, 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 can not 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): NCT03194399


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: NCT03194399     History of Changes
Other Study ID Numbers: E-1509-314-002
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: June 21, 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