Life Style Modification for Breast Canccer Survivors Using Mobile App-based Human Coaching Program

• Sponsor: National Cancer Center, Korea (Other)
• Overall Status: Completed
• CT.gov ID: NCT05506189
• Collaborator: (none)
• Enrollment: 130
• Location: 1
• Actual Duration (Months): 37.6
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Survivors	Other: mobile application program with human coach

Study Design

• Study Type: Observational
• Actual Enrollment: 130 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: 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
• Actual Study Start Date: May 14, 2019
• Actual Primary Completion Date: Dec 31, 2021
• Actual Study Completion Date: Jun 30, 2022

Arms and Interventions

Arm	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.	Other: mobile application program with human coach; 6-months mobile application program with human coach for life-style modifiation including diet and exercise

Outcome Measures

Primary Outcome Measures

1. reduction of body mass index (BMI) [Baseline and 6 month]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. breast cancer survivors who have completed acute treatment of breast cancer

2. Age: 18 ~ 70 year old

3. stage: I, II, III

4. BMI≥25.0 Kg/m2

5. breast cancer survovrs who can use mobile application program

6. breast cancer survovrs who agree with this study's consent

Exclusion Criteria:

1. Stage IV, carcinoma in situ

2. breast cancer survivors who don't use smartphone

3. breast cancer survivors with previous other malignant disease

4. breast cancer survivors with multiple malignancies

5. breast cancer survivors with uncontrolled chronic comorbid disease

6. breast cancer survovrs who disagree with this study's consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cancer Center	Goyang-si	Gyeonggi-do	Korea, Republic of	410-769

Sponsors and Collaborators

• National Cancer Center, Korea

Investigators

• Principal Investigator: So-Youn Jung, MD PhD, Center for Breast Cancer, National Cancer Center, Korea

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: So-Youn Jung, Breast Surgeon, National Cancer Center, Korea
• ClinicalTrials.gov Identifier: NCT05506189
• Other Study ID Numbers: NCC 2019-0098
• First Posted: Aug 18, 2022
• Last Update Posted: Aug 18, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Aug 18, 2022