NCT05506189

Brief Summary

This study is aimed to investigate whether mobile app-based human coaching program for 6 months is effective for reducing BMI in breast cancer survivors with overweight and obesity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

May 14, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

2.6 years

First QC Date

August 16, 2022

Last Update Submit

August 16, 2022

Conditions

Breast Cancer Survivors

Outcome Measures

Primary Outcomes (1)

  • reduction of body mass index (BMI)

    whether the 6-month mobile program can be effective for reducing BMI

    Baseline and 6 month

Study Arms (1)

Breast cancer survivors with over-weight or obesity

Breast cancer survivors with 25 and more than 25 of BMI will be supported with 6 months life style modification program using mobile application including human coach for reducing BMI.

Other: mobile application program with human coach

Interventions

mobile application program with human coachOTHER

6-months mobile application program with human coach for life-style modifiation including diet and exercise

Breast cancer survivors with over-weight or obesity

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

breast cancer survivors with 25 and more than 25 of BMI

You may qualify if:

  • breast cancer survivors who have completed acute treatment of breast cancer
  • Age: 18 \~ 70 year old
  • stage: I, II, III
  • BMI≥25.0 Kg/m2
  • breast cancer survovrs who can use mobile application program
  • breast cancer survovrs who agree with this study's consent

You may not qualify if:

  • Stage IV, carcinoma in situ
  • breast cancer survivors who don't use smartphone
  • breast cancer survivors with previous other malignant disease
  • breast cancer survivors with multiple malignancies
  • breast cancer survivors with uncontrolled chronic comorbid disease
  • breast cancer survovrs who disagree with this study's consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Study Officials

  • So-Youn Jung, MD PhD

    Center for Breast Cancer, National Cancer Center, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Breast Surgeon

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 18, 2022

Study Start

May 14, 2019

Primary Completion

December 31, 2021

Study Completion

June 30, 2022

Last Updated

August 18, 2022

Record last verified: 2022-08

Locations

KR(1)