NCT03200067

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2017

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

June 27, 2017

Status Verified

June 1, 2017

Enrollment Period

2 months

First QC Date

June 20, 2017

Last Update Submit

June 25, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient health ability change

    Measuring Health and Disability WHODAS 2.0

    Baseline and after 4 weeks, 8 weeks of lifestyle modification

Secondary Outcomes (3)

  • Lab test result change

    Baseline and after 4 weeks, 8 weeks of lifestyle modification

  • Patient satisfaction change on mobile service

    Baseline and after 4 weeks, 8 weeks of lifestyle modification

  • Patient satisfaction change on healthcare management

    Baseline and after 4 weeks, 8 weeks of lifestyle modification

Study Arms (2)

Personalized rehabilitation service group

EXPERIMENTAL

Breast cancer patients who use mobile healthcare service application and receive personal feedback from clinician

Behavioral: Personalized health care service

Conventional group

NO INTERVENTION

Breast cancer patients with conventional care

Interventions

Personalized health care service, such as rehabilitation exercise recommendation, lifestyle activity coaching, health data monitoring

Personalized rehabilitation service group

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Breast cancer patient (age over 18), Cancer stage under 3, Android OS smartphone user

You may not qualify if:

  • Cancer stage over 4, Patients diagnosed with multiple cancer, Patient who cannot participate rehabilitation exercise program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national university bundang hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsLymphedema

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Eunjoo Yang, PhD

    Seoul National University Bundang Hospital

    STUDY CHAIR

Central Study Contacts

Borim Ryu, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study chair

Study Record Dates

First Submitted

June 20, 2017

First Posted

June 27, 2017

Study Start

June 3, 2017

Primary Completion

August 1, 2017

Study Completion

September 1, 2017

Last Updated

June 27, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations