Breast CancerNCT03186599
Analysis of Initial Adherence and Its Impact on Long-term Adherence to Hormonal Therapy for Breast Cancer
A study testing low adherence intervention group in people with Breast Cancer, run by Gachon University at 1 site in South Korea.
Trial summary
A trial will be conducted on 200 breast cancer patients with adjuvant hormonal therapy. The study included 6 months baseline measurement, and 12 months intervention. Patients will be assigned to high adherence or low adherence group. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- low adherence intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Jun 2017to 31 Oct 2018
- Phase
- Interventional
- 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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage 0-III breast cancer
- Treated with Adjuvant hormonal therapy
Who cannot join
- Stage IV breast cancer
- Breast cancer recurrence or metastasis
- Severe medical illness
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical center
Seoul, 05505
Min Sun Lee, RN, 010-8964-9614, minsunlee1989@gmail.com
About this study
A trial will be conducted on 200 breast cancer patients with adjuvant hormonal therapy. The study included 6 months baseline measurement, and 12 months intervention. Patients will be assigned to high adherence or low adherence group. Then, through randomization, low adherence patients will be assigned to the intervention or control group. Study Coordinator delivers the intervention using the WALKON mobile application. Control participants receive usual care with continuous monitoring using Medication Event Monitoring System (MEMS) device.
Read the detailed description
- Baseline measurement (n=200): screening and enrollment
- 3-month visit: collecting MEMS data
- 6-month visit: collecting MEMS data and assigned to the high adherence (n=70) or low adherence group (n=75). The low adherence intervention group (n=75) will be educated about the WALKON mobile application.
- 12-month visit: Control group: collecting MEMS data intervention group: monthly calls + collecting MEMS data
- 18-month visit: collecting MEMS data and interview
- Conditions
- Breast Cancer
- Being tested
- low adherence intervention group
- Keywords
- Medication Event Monitoring System, adherence
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low adherence intervention groupBehavioural
Monthly, the study coordinator will give calls to encourage physical activities and medication adherence using MEMS and WALKON activity data.
| Study group | Role | What they receive |
|---|---|---|
| high adherence control group | No intervention | -Patients on continuous MEMS monitoring with usual care. |
| low adherence control group | No intervention | -Patients on continuous MEMS monitoring with usual care. |
| low adherence intervention group | Experimental | * Patient with the WALKON mobile application.
* Patient with monthly feedback call
* Patients on continuous MEMS monitoring. Receives: Behavioral: low adherence intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical activity (daily steps)
Comparison of daily steps using WALKON application
Measured: 12 months
Secondary outcomes (1)
Medication adherence using MEMS device
Comparison of adjuvant hormonal therapy adherence using MEMS device
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start8 Jun 2017
- Primary completion31 Oct 2018 (estimated)
- Study completion31 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gachon University
- Sponsor type
- University, hospital or other
- Collaborators
- Asan Medical Center
- Responsible party
- Principal investigator, Yul Ha Min, Gachon University
- Investigators
- Yul ha Min, PhD, Principal investigator, Gachon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186599
- Sponsor's protocol ID
- 2016-0351
- Status last verified
- Jun 2017
- First submitted
- 9 Jun 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Initial Adherence and Its Impact on Long-term Adherence to Hormonal Therapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT03186599
- Acronym / sponsor ID
- 2016-0351
- Conditions
- Breast Cancer
- Keywords
- Medication Event Monitoring System, adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Gachon UniversityUniversity, hospital or other
- Collaborators
- Asan Medical Center
- Study start
- 8 Jun 2017 (actual)
- Primary completion
- 31 Oct 2018 (estimated)
- Study completion
- 31 Oct 2018 (estimated)
- First posted
- 14 Jun 2017 (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.
A trial will be conducted on 200 breast cancer patients with adjuvant hormonal therapy. The study included 6 months baseline measurement, and 12 months intervention. Patients will be assigned to high adherence or low adherence group. Then, through randomization, low adherence patients will be assigned to the intervention or control group. Study Coordinator delivers the intervention using the WALKON mobile application. Control participants receive usual care with continuous monitoring using Medication Event Monitoring System (MEMS) device.
Detailed description
- Baseline measurement (n=200): screening and enrollment
- 3-month visit: collecting MEMS data
- 6-month visit: collecting MEMS data and assigned to the high adherence (n=70) or low adherence group (n=75). The low adherence intervention group (n=75) will be educated about the WALKON mobile application.
- 12-month visit: Control group: collecting MEMS data intervention group: monthly calls + collecting MEMS data
- 18-month visit: collecting MEMS data and interview
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| high adherence control group | No intervention | –-Patients on continuous MEMS monitoring with usual care. |
| low adherence control group | No intervention | –-Patients on continuous MEMS monitoring with usual care. |
| low adherence intervention group | Experimental | Behavioral: low adherence intervention group* Patient with the WALKON mobile application. * Patient with monthly feedback call * Patients on continuous MEMS monitoring. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stage 0-III breast cancer
- Treated with Adjuvant hormonal therapy
Key exclusion criteria (3 listed)
- Stage IV breast cancer
- Breast cancer recurrence or metastasis
- Severe medical illness
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 |
|---|---|---|
| low adherence intervention groupMonthly, the study coordinator will give calls to encourage physical activities and medication adherence using MEMS and WALKON activity data. | Behavioural | low adherence intervention group |
Primary outcome
physical activity (daily steps)
Time frame: 12 months
Comparison of daily steps using WALKON application
1 secondary outcome
Medication adherence using MEMS device
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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.
Yul ha Min, PhD principal investigator
Gachon University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low adherence intervention group in people with Breast Cancer, run by Gachon University 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Jun 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yul ha Min, PhD (032-820-4227, yulha@gachon.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physical activity (daily steps) (time frame: 12 months). 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 14 Jun 2017.