Breast Cancer SurvivorsNCT05506189
Life Style Modification for Breast Canccer Survivors Using Mobile App-based Human Coaching Program
An observational study of Breast Cancer Survivors, run by National Cancer Center, Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer Survivors
- What is being tested?
- mobile application program with human coach
- How many people
- 130 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 May 2019to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: breast cancer survivors with 25 and more than 25 of BMI
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Breast Cancer Survivors
- Being tested
- mobile application program with human coach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile application program with human coachOther
6-months mobile application program with human coach for life-style modifiation including diet and exercise
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: mobile application program with human coach |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of body mass index (BMI)
whether the 6-month mobile program can be effective for reducing BMI
Measured: Baseline and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start14 May 2019
- Primary completion31 Dec 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, So-Youn Jung, National Cancer Center, Korea
- Investigators
- So-Youn Jung, MD PhD, Principal investigator, Center for Breast Cancer, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506189
- Sponsor's protocol ID
- NCC 2019-0098
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2022
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05506189
- Acronym / sponsor ID
- NCC 2019-0098
- Conditions
- Breast Cancer Survivors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 14 May 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 18 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer survivors with over-weight or obesity | – | Other: mobile application program with human coachBreast 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- breast cancer survivors with 25 and more than 25 of BMI
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mobile application program with human coach6-months mobile application program with human coach for life-style modifiation including diet and exercise | Other | Breast cancer survivors with over-weight or obesity |
Primary outcome
reduction of body mass index (BMI)
Time frame: Baseline and 6 month
whether the 6-month mobile program can be effective for reducing BMI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
So-Youn Jung, MD PhD principal investigator
Center for Breast Cancer, National Cancer Center, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Survivors, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of body mass index (BMI) (time frame: Baseline and 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.