An interventional study of Cohort1: Pinkmate Agentic AI-ePRO Active Management Platform and Cohort1: Pinkmate Basic Medication Reminders and Standard Outpatient Care in Breast Neoplasm Malignant Primary, Lymphedema Arm and Medication Adherence, sponsored by Chang-Ik Yoon. Not yet recruiting at 1 site in South Korea. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Chang-Ik Yoon · Not applicable, Interventional, and Supportive care
As survival rates following breast cancer surgery continue to improve, long-term survivorship management has emerged as a crucial clinical priority. In particular, two major clinical challenges remain: (1) maintaining medication adherence to 5 to 10 years of adjuvant endocrine therapy (tamoxifen or aromatase inhibitors) by actively managing treatment-related adverse symptoms, and (2) early detection and prevention of chronic breast cancer-related lymphedema following axillary lymph node dissection (ALND). Conventional passive monitoring relying on routine outpatient visits every 3 to 6 months often fails to detect daily symptom worsening or subclinical fluid accumulation in a timely manner.
This single-center, prospective, open-label, parallel-group randomized clinical trial evaluates the efficacy of an Agentic AI-based digital healthcare application (Pinkmate; a non-medical mobile health app) and a home bioelectrical impedance analyzer (InBody BWA ON) across two independent cohorts under a single master protocol. This study is conducted at Seoul St. Mary's Hospital and supported by the National IT Industry Promotion Agency (NIPA; Grant No. PJT-25-050007). Dual enrollment is permitted for patients meeting eligibility criteria for both cohorts (total target enrollment: 264 participants).
STUDY DESIGN AND RATIONALE This study is a single-center, prospective, randomized, open-label, parallel-group clinical trial conducted at the Breast Center (Departments of Surgery and Rehabilitation Medicine) of Seoul St. Mary's Hospital, Republic of Korea. The study is supported by the National IT Industry Promotion Agency (NIPA; Grant No. PJT-25-050007) as part of the national Dr. Answer 3.0 digital healthcare project.
Within a single master protocol, two independent clinical research questions are evaluated across two cohorts with independent central computerized 1:1 stratification (stratified by dominant arm concordance with the operated side, radiotherapy status, and body mass index [BMI]):
STUDY PRODUCTS
INTERVENTION PROTOCOLS [Cohort 1: Medication Adherence (N=200)]
[Cohort 2: Lymphedema Monitoring (N=64)] Sixty-four patients who underwent ALND (including newly operated patients and prior ALND patients who currently have no clinical lymphedema) are randomized 1:1.
Official clinical diagnosis and initiation of rehabilitation therapy are determined identically in both groups based on in-clinic InBody 770 and tape circumference measurements:
SAMPLE SIZE JUSTIFICATION AND STATISTICAL PLAN
937 studies on the registry are indexed under Medication Adherence; 159 are open to participants now.
This study's planned enrollment of 264 is above the median of 120 across 768 interventional studies indexed under Medication Adherence.
Browse Medication Adherence studies →Chang-Ik Yoon is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Cohort 1 (Medication Adherence and Active Symptom Management, N=200):
Cohort 2 (Early Lymphedema Monitoring and Management, N=64):
Dual Enrollment:
* Patients who fulfill the eligibility criteria for both Cohort 1 and Cohort 2 may be enrolled simultaneously in both cohorts with independent 1:1 randomization in each. Randomization assignment in one cohort does not influence assignment in the other cohort.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive the Pinkmate mobile app with active electronic patient-reported outcomes (ePRO) and Agentic AI monitoring. Patients complete weekly ePRO questionnaires. In addition, reporting adverse symptoms (e.g., fatigue, arthralgia) to the conversational AI chatbot immediately triggers targeted in-depth ePRO assessments. When symptom scores worsen beyond predefined thresholds, the patient is automatically flagged on the clinician dashboard. Clinical staff review the dashboard daily (business days) and conduct proactive telephone consultations within 48 hours to provide supportive care, symptom relief education, medication adherence counseling, and expedited clinic referrals.
Behavioral: Cohort1: Pinkmate Agentic AI-ePRO Active Management Platform
Participants use the Pinkmate mobile app limited to basic medication reminders, daily check-in logs, and quarterly ePRO surveys (every 3 months) aligned with routine outpatient visit schedules. Conversational AI chatbot-triggered questionnaires, automated clinician dashboard alert flagging, and proactive 48-hour telephone intervention by medical staff are disabled. Symptoms and medication adherence are managed during routine in-person outpatient clinic visits according to standard care.
Other: Cohort1: Pinkmate Basic Medication Reminders and Standard Outpatient Care
Breast cancer patients who underwent ALND (including newly operated patients and prior ALND patients without clinical lymphedema) are loaned a home bioimpedance analyzer (InBody BWA ON, loaned until Dec 31, 2028). Patients perform self-measurements at home at least twice weekly (daily recommended; on waking, post-voiding) linked to the Pinkmate app. Persistent dashboard alerts (affected-arm ΔECW/TBW ≥ 0.010 or interlimb ratio ≥ 1.020 for 3 days) trigger clinical staff phone calls within 48 hours for self-care reinforcement and early clinic visits. Participants also utilize app-based AI lifestyle coaching and fluid tracking graphs. In-clinic InBody 770 and circumference tape measurements are performed at routine visits.
Device: Cohort2: InBody BWA ON Home Bioimpedance Monitoring and Behavioral App
Breast cancer patients who underwent ALND do not receive the home InBody BWA ON device and use the Pinkmate app solely for educational self-care content and scheduled surveys. Continuous home bioimpedance data linkage and real-time dashboard alerts are disabled. Limb volume and bioimpedance are evaluated exclusively during scheduled outpatient visits using in-clinic InBody 770 and circumference tape measurements. Standardized rehabilitation therapy upon meeting criteria for subclinical or clinical lymphedema is administered identically to the experimental arm.
Other: Cohort2: Routine In-Clinic InBody 770 Monitoring and Educational App
Closed-access mobile health application (Pinkmate) featuring an Agentic AI conversational chatbot and electronic patient-reported outcomes (ePRO) module. Participants complete weekly ePRO symptom surveys. In addition, adverse symptom complaints during chatbot interactions automatically trigger targeted in-depth ePRO questionnaires. Worsening symptoms beyond predefined thresholds generate alert flags on the clinician web dashboard. Clinical staff monitor the dashboard daily (business days) and conduct proactive telephone consultations within 48 hours of an alert to provide supportive care, symptom relief education, medication counseling, or expedited clinic referrals.
Also known as: Pinkmate App
Participants utilize the Pinkmate mobile application with functionality limited to basic medication reminders, daily adherence check-ins, and quarterly (every 3 months) ePRO questionnaires aligned with scheduled outpatient clinic visits. Automated conversational AI chatbot symptom triggers, clinician dashboard alert flags, and proactive 48-hour telephone consultations are disabled. Adverse symptom evaluation, medication counseling, and management are conducted during routine in-person outpatient clinic visits according to standard clinical practice.
Also known as: Standard care with basic Pinkmate app
Participants receive a loaned portable multi-frequency bioelectrical impedance analyzer (InBody BWA ON; MFDS License No. 19-4025; loaned until December 31, 2028). Patients perform self-measurements at home under standardized morning post-voiding conditions at least twice weekly (daily recommended). Data are transmitted via Bluetooth to the Pinkmate app and clinician dashboard. Persistent bioimpedance alerts (affected-arm ΔECW/TBW ratio ≥ 0.010 from baseline or interlimb ratio ≥ 1.020 for 3 consecutive days) trigger medical staff telephone counseling within 48 hours for self-care reinforcement and early clinic visits. Participants also utilize app-based AI lifestyle coaching and arm fluid tracking graphs. In-clinic InBody 770 measurements are performed at routine visits.
Also known as: InBody BWA ON (MFDS License No. 19-4025)
Participants do not receive the home InBody BWA ON device and use the Pinkmate mobile application solely for educational self-care content and scheduled surveys. Continuous home bioimpedance data linkage and real-time dashboard alert flagging are disabled. Arm swelling and segmental bioimpedance are evaluated exclusively during routine outpatient visits (at 3, 6, 12, 24, 36, and 60 months) using the in-clinic InBody 770 analyzer (MFDS License No. 13-1188) and circumference tape measurements. Standardized rehabilitation therapy upon meeting predefined criteria for subclinical or clinical lymphedema is administered identically to the experimental arm.
Also known as: Standard surveillance with InBody 770 (MFDS No. 13-1188)
Cohort1: Proportion of Days Covered (PDC) for Adjuvant Endocrine Therapy
PDC is defined as the percentage of days during the evaluation period that the participant actually took prescribed adjuvant endocrine therapy (tamoxifen or aromatase inhibitors). It is calculated from prescription records and daily in-app medication check logs: PDC = (Number of days medication taken / Total observation days) × 100. Mean PDC and the proportion of participants achieving PDC ≥ 80% are compared between arms.
Time frame: At 6 months after intervention initiation
Cohort2: Percentage Change from Baseline in Affected Upper Limb Volume
Limb volume is derived from bilateral upper limb circumferences measured every 4 cm starting 2 cm below the axilla down to the wrist using a standardized tape measure (mean of two measurements). Volume is calculated using the truncated cone formula. The relative percentage change in affected upper limb volume from baseline to 6 months post-enrollment is compared between arms.
Time frame: Baseline (enrollment) and 6 months after enrollment
Cohort2: Change from Baseline in Affected Upper Limb ECW/TBW Ratio
Segmental extracellular water-to-total body water ratio (ECW/TBW) of the affected upper limb is measured using the in-clinic multi-frequency bioelectrical impedance analyzer (InBody 770). The change in affected-arm ECW/TBW ratio from baseline to 6 months post-enrollment (ΔECW/TBW) is compared between arms.
Time frame: Baseline (enrollment) and 6 months after enrollment
Cohort1: Long-Term Proportion of Days Covered (PDC) for Adjuvant Endocrine Therapy
PDC is calculated as the percentage of days covered by prescribed adjuvant endocrine therapy at each follow-up time point, analyzed over time across arms using a linear mixed model (LMM).
Time frame: At 12, 24, 36, and 60 months after intervention initiation
Cohort1: Change from Baseline in Functional Assessment of Cancer Therapy - Breast (FACT-B) Score
Quality of life is assessed using the Korean version of FACT-B (Version 4). Total score ranges from 0 to 148, with higher scores reflecting better breast cancer-specific health-related quality of life.
Time frame: Baseline, and at 3, 6, 12, 24, 36, and 60 months
Cohort1: Change from Baseline in Endocrine Therapy-Related Symptom PRO T-scores
Standardized ePRO symptom T-scores for key endocrine therapy-associated adverse symptoms (including fatigue and arthralgia) collected via the mobile application.
Time frame: Baseline, and at 3, 6, 12, 24, 36, and 60 months
Cohort2: Cumulative Incidence of Subclinical and Clinical Upper Limb Lymphedema
Proportion of participants developing subclinical lymphedema (affected-arm volume increase ≥ 5% to \< 10% or InBody 770 ΔECW/TBW ≥ 0.010) or clinical lymphedema (affected-arm volume increase ≥ 10% or InBody 770 ECW/TBW ≥ 0.395).
Time frame: At 6, 12, 24, 36, and 60 months after enrollment
Cohort2: Progression of International Society of Lymphology (ISL) Lymphedema Stage
Proportion of participants experiencing progression from ISL Stage 1 to Stage 2 or higher based on clinical evaluation by a rehabilitation medicine specialist.
Time frame: Baseline, and at 6, 12, 24, 36, and 60 months after enrollment
Both Cohorts: System Usability Scale (SUS) Score for Pinkmate Mobile Application
Patient-evaluated usability of the Pinkmate mobile health application using the System Usability Scale (SUS). Total score ranges from 0 to 100, where higher scores indicate greater usability and satisfaction.
Time frame: At 12, 24, 36, and 60 months after intervention initiation
Plan to share: No — Individual participant data (IPD) will not be publicly shared due to patient privacy protection regulations and institutional policy regarding sensitive digital health and clinical data. De-identified aggregate data or summary results may be provided by the corresponding author upon reasonable academic request following publication of the primary study results.
Start is estimated for Oct 2026; primary completion for Dec 2028, 26 months later.
Of 425 non-industry interventional studies with no phase under Medication Adherence, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 42. This study's planned 26 months is above that.
Counting every sponsor, half of 442 studies reached it within 21 months; a quarter within 11 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chang-Ik Yoon