Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE June 20, 2017
First Posted Date  ICMJE June 27, 2017
Last Update Posted Date June 27, 2017
Actual Study Start Date  ICMJE June 3, 2017
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2017)
Patient health ability change [ Time Frame: Baseline and after 4 weeks, 8 weeks of lifestyle modification ]
Measuring Health and Disability WHODAS 2.0
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2017)
  • Lab test result change [ Time Frame: Baseline and after 4 weeks, 8 weeks of lifestyle modification ]
    Laboratory test (Blood test)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects on the Personalized Rehabilitation Service in Patients With Cancer
Official Title  ICMJE Effects on the Personalized Rehabilitation Service in Patients With Cancer
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Breast Cancer
  • Breast Neoplasms
  • Breast Cancer Female
  • Lymphedema
Intervention  ICMJE Behavioral: Personalized health care service
Personalized health care service, such as rehabilitation exercise recommendation, lifestyle activity coaching, health data monitoring
Study Arms  ICMJE
  • Experimental: Personalized rehabilitation service group
    Breast cancer patients who use mobile healthcare service application and receive personal feedback from clinician
    Intervention: Behavioral: Personalized health care service
  • No Intervention: Conventional group
    Breast cancer patients with conventional care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 25, 2017)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2017
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03200067
Other Study ID Numbers  ICMJE B-1705/395-302
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eun Joo Yang, Seoul National University Bundang Hospital
Study Sponsor  ICMJE Seoul National University Bundang Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Eunjoo Yang, PhD Seoul National University Bundang Hospital
PRS Account Seoul National University Bundang Hospital
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP