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Development of Personalized Health Care Service in Patients With Breast Cancer

Primary Purpose

Breast Cancer, Lymphedema, Cancer-related Problem/Condition

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Personalized health care service
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Breast cancer patients

    Arm Description

    Outcomes

    Primary Outcome Measures

    Patient satisfaction change
    Patient subjective evaluation by survey on satisfaction

    Secondary Outcome Measures

    Physical activity change
    Physical activity measurement by step count
    Functional outcome change
    (Physical)Functional outcome measurement by breast cancer patient questionnaire
    Quality of care change
    Quality of care measurement by breast cancer patient questionnaire

    Full Information

    First Posted
    June 7, 2017
    Last Updated
    June 20, 2017
    Sponsor
    Seoul National University Bundang Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03194399
    Brief Title
    Development of Personalized Health Care Service in Patients With Breast Cancer
    Official Title
    Development of Personalized Health Care Service in Patients With Breast Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 27, 2015 (Actual)
    Primary Completion Date
    February 15, 2016 (Actual)
    Study Completion Date
    February 22, 2016 (Actual)

    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 develop effective personalized healthcare service program for breast cancer rehabilitation, we 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, Lymphedema, Cancer-related Problem/Condition

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    11 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Breast cancer patients
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    Personalized health care service
    Intervention Description
    Physical activity coaching, other functional outcome observation
    Primary Outcome Measure Information:
    Title
    Patient satisfaction change
    Description
    Patient subjective evaluation by survey on satisfaction
    Time Frame
    Baseline and after 2 weeks, 4 weeks of lifestyle modification
    Secondary Outcome Measure Information:
    Title
    Physical activity change
    Description
    Physical activity measurement by step count
    Time Frame
    Baseline and after 2 weeks, 4 weeks of lifestyle modification
    Title
    Functional outcome change
    Description
    (Physical)Functional outcome measurement by breast cancer patient questionnaire
    Time Frame
    Baseline and after 2 weeks, 4 weeks of lifestyle modification
    Title
    Quality of care change
    Description
    Quality of care measurement by breast cancer patient questionnaire
    Time Frame
    Baseline and after 2 weeks, 4 weeks of lifestyle modification

    10. Eligibility

    Sex
    Female
    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 can not participate rehabilitation exercise program
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Development of Personalized Health Care Service in Patients With Breast Cancer

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