NCT03194399

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).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable breast-cancer

Status
completed

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

November 27, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2016

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 21, 2017

Completed
Last Updated

June 21, 2017

Status Verified

June 1, 2017

Enrollment Period

3 months

First QC Date

June 7, 2017

Last Update Submit

June 20, 2017

Conditions

Breast CancerLymphedemaCancer-related Problem/Condition

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction change

    Patient subjective evaluation by survey on satisfaction

    Baseline and after 2 weeks, 4 weeks of lifestyle modification

Secondary Outcomes (3)

  • Physical activity change

    Baseline and after 2 weeks, 4 weeks of lifestyle modification

  • Functional outcome change

    Baseline and after 2 weeks, 4 weeks of lifestyle modification

  • Quality of care change

    Baseline and after 2 weeks, 4 weeks of lifestyle modification

Study Arms (1)

Breast cancer patients

EXPERIMENTAL
Behavioral: Personalized health care service

Interventions

Personalized health care serviceBEHAVIORAL

Physical activity coaching, other functional outcome observation

Breast cancer patients

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (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 can not participate rehabilitation exercise program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Chair

Study Record Dates

First Submitted

June 7, 2017

First Posted

June 21, 2017

Study Start

November 27, 2015

Primary Completion

February 15, 2016

Study Completion

February 22, 2016

Last Updated

June 21, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share