- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05506189
Life Style Modification for Breast Canccer Survivors Using Mobile App-based Human Coaching Program
August 16, 2022 updated by: So-Youn Jung, National Cancer Center, Korea
A Prospective Study on the Effect of Quality of Life and Life Style Modification for Breast Cancer Survivors Using Mobile App-based Human Coaching Program
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
130
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeonggi-do
-
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
- National Cancer Center
-
-
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 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
breast cancer survivors with 25 and more than 25 of BMI
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
6-months mobile application program with human coach for life-style modifiation including diet and exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
reduction of body mass index (BMI)
Time Frame: Baseline and 6 month
|
whether the 6-month mobile program can be effective for reducing BMI
|
Baseline and 6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: So-Youn Jung, MD PhD, Center for Breast Cancer, National Cancer Center, Korea
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)
May 14, 2019
Primary Completion (ACTUAL)
December 31, 2021
Study Completion (ACTUAL)
June 30, 2022
Study Registration Dates
First Submitted
August 16, 2022
First Submitted That Met QC Criteria
August 16, 2022
First Posted (ACTUAL)
August 18, 2022
Study Record Updates
Last Update Posted (ACTUAL)
August 18, 2022
Last Update Submitted That Met QC Criteria
August 16, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCC 2019-0098
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.