Effects on the Personalized Rehabilitation Service in Patients With Cancer

June 25, 2017 updated by: Eun Joo Yang, Seoul National University Bundang Hospital
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Seongnam, Gyeonggi, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient health ability change
Time Frame: Baseline and after 4 weeks, 8 weeks of lifestyle modification
Measuring Health and Disability WHODAS 2.0
Baseline and after 4 weeks, 8 weeks of lifestyle modification

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lab test result change
Time Frame: Baseline and after 4 weeks, 8 weeks of lifestyle modification
Laboratory test (Blood test)
Baseline and after 4 weeks, 8 weeks of lifestyle modification
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
Baseline and after 4 weeks, 8 weeks of lifestyle modification
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
Baseline and after 4 weeks, 8 weeks of lifestyle modification

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Study Chair: Eunjoo Yang, PhD, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2017

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

June 20, 2017

First Submitted That Met QC Criteria

June 25, 2017

First Posted (Actual)

June 27, 2017

Study Record Updates

Last Update Posted (Actual)

June 27, 2017

Last Update Submitted That Met QC Criteria

June 25, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1705/395-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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