Development of Personalized Health Care Service in Patien... | NCT03194399

Studies
Development of Personalized Health Care Service in Patients With Breast Cancer

NCT03194399

Sponsor

Seoul National University Bundang Hospital

Status

Completed

Last Update Posted

Jun 21, 2017Actual

Enrollment

11Actual

Phase

Not Applicable

Conditions

Breast Cancer
Lymphedema
Cancer-related Problem/Condition

Interventions

Personalized health care service

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 27, 2015Actual

Primary Completion Date

Feb 15, 2016Actual

Completion Date

Feb 22, 2016Actual

First Submitted Date

Jun 7, 2017

First Submission Date that Met QC Criteria

Jun 20, 2017

First Posted Date

Jun 21, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2017

Last Update Posted Date

Jun 21, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eun Joo Yang, Study Chair, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Breast cancer patients	Experimental		Behavioral: Personalized health care service

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Personalized health care service	Behavioral	Physical activity coaching, other functional outcome observation	Breast cancer patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient satisfaction change	Patient subjective evaluation by survey on satisfaction	Baseline and after 2 weeks, 4 weeks of lifestyle modification

Secondary Outcomes

Measure	Description	Time Frame
Physical activity change	Physical activity measurement by step count	Baseline and after 2 weeks, 4 weeks of lifestyle modification
Functional outcome change	(Physical)Functional outcome measurement by breast cancer patient questionnaire

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eunjoo Yang, PhD	Seoul National University Bundang Hospital	Study Chair

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D008209	Lymphedema

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided