AzTrials
AzTrials

Breast Neoplasm Malignant PrimaryPinkmateNCT07911839

Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors

A study testing Cohort1: Pinkmate Agentic AI-ePRO Active Management Platform, Cohort1: Pinkmate Basic Medication Reminders and Standard Outpatient Care and Cohort2: InBody BWA ON Home Bioimpedance Monitoring and Behavioral App in people with Breast Neoplasm Malignant Primary and Lymphedema Arm, run by Chang-Ik Yoon at 1 site in South Korea.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Cohort1: Pinkmate Agentic AI-ePRO Active Management Platform, Cohort1: Pinkmate Basic Medication Reminders and Standard Outpatient Care and Cohort2: InBody BWA ON Home Bioimpedance Monitoring and Behavioral App
Could I receive a placebo?
No, everyone receives an active treatment
How many people
264 participants
Where
1 siteSouth Korea
Study dates
29 Oct 2026to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cohort 1 (Medication Adherence and Active Symptom Management, N=200):
  • Adults aged 18 to under 75 years.
  • Diagnosed with invasive breast cancer or ductal carcinoma in situ (ICD-10 code: C50 or D05) and underwent breast cancer surgery.
  • Pathologic or clinical stage 0 to III.
  • Initiated or scheduled to initiate adjuvant endocrine therapy (tamoxifen or aromatase inhibitor) after surgery.
  • Capable of using a smartphone (and agree to install and use the study mobile application).
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  • Voluntarily decided to participate in the study and provided signed written informed consent.
  • Cohort 2 (Early Lymphedema Monitoring and Management, N=64):
  • Adults aged 18 to under 75 years.
  • Diagnosed with invasive breast cancer (ICD-10 code: C50, Stage I to III) and underwent breast cancer surgery.
  • Underwent axillary lymph node dissection (ALND) during surgery (including patients newly undergoing ALND and patients with prior ALND who currently have no clinical lymphedema).
  • Capable of independently operating the home bioelectrical impedance analyzer (InBody BWA ON) at home.
  • Capable of using a smartphone (and agree to install and use the study mobile application).
  • Voluntarily decided to participate in the study and provided signed written informed consent.
  • 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.

Who cannot join

  • Bilateral breast cancer patients who underwent bilateral axillary lymph node dissection (ALND) (Note: bilateral breast cancer patients who underwent unilateral ALND are eligible).
  • History of another malignancy diagnosed within the past 5 years (except for breast ductal carcinoma in situ [ICD-10 code: D05], which is eligible).
  • Patients with implanted electronic medical devices (e.g., cardiac pacemakers) or metallic implants precluding the use of bioelectrical impedance analyzers (applicable to Cohort 2 only).
  • Presence of pre-existing Grade 3 or higher upper limb lymphedema prior to surgery or enrollment (applicable to Cohort 2 only).
  • Severe cognitive or coordination impairment preventing mobile application use or self-care.
  • Severe comorbid disease precluding study participation.
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  • Pregnant at the time of enrollment.
  • Judged unsuitable for data collection in the judgment of the principal investigator.
  • Inability or difficulty understanding and completing study questionnaires.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chang-Ik Yoon, MD, PhD contact

+82-2-2258-6109

fayn03@catholic.ac.kr

Je Hyun Chin, MD contact

+82-2-2258-6368

jchin@catholic.ac.kr

South Korea1 site

  • Seoul St. Mary's Hospital, The Catholic University of Korea

    Seoul, 06319

    Chang-Ik Yoon, MD, PhD, +82-2-2258-6109, fayn03@catholic.ac.kr

    Je Hyun Chin, MD, +82-2-2258-6368, jchin@catholic.ac.kr

Other trials in South Korea

About this study

Official title: Efficacy of an Agentic AI-based Integrated Digital Healthcare Service for Personalized Prognosis Management in Breast Cancer

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).

  1. Cohort 1: Medication Adherence and Active Symptom Management (N=200) Two hundred breast cancer patients initiating or receiving adjuvant endocrine therapy are randomized 1:1. The experimental arm receives weekly electronic patient-reported outcomes (ePRO), conversational AI chatbot-triggered symptom questionnaires, clinician dashboard alert flags, and proactive telephone calls from clinical staff within 48 hours of an alert. The control arm uses basic medication reminders/checklists and quarterly ePRO collection without proactive alerts. The primary endpoint is the Proportion of Days Covered (PDC) at 6 months.
  2. Cohort 2: Early Lymphedema Monitoring and Management (N=64) Sixty-four breast cancer patients who underwent ALND (including newly operated patients and prior ALND patients without clinical lymphedema) are randomized 1:1. The experimental arm uses a loaned home InBody BWA ON device at least twice weekly linked to the Pinkmate app; persistent dashboard alerts (3 consecutive days) trigger proactive phone counseling and early clinic visit recommendations. The control arm undergoes routine outpatient surveillance using the in-clinic InBody 770 analyzer and tape measurements, along with educational self-care app content. In both arms, standardized rehabilitation therapy is initiated based on in-clinic InBody 770 and tape circumference measurements using identical criteria. The primary endpoints are the percentage change in affected upper limb volume and the change in affected-arm ECW/TBW ratio from baseline to 6 months post-enrollment.
Read the detailed description

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]):

  1. Cohort 1: Medication Adherence (N=200; 100 experimental vs 100 control)
  2. Cohort 2: Lymphedema Prevention (N=64; 32 experimental vs 32 control) Patients who satisfy the eligibility criteria for both Cohort 1 and Cohort 2 may be enrolled simultaneously in both cohorts (Dual Enrollment), resulting in a total target sample size of 264 participants.

STUDY PRODUCTS

  1. Pinkmate Application (DigitalPharm Co., Ltd.): A closed-access, non-medical health management mobile application (access granted via unique research code and user verification). Features include an Agentic AI chatbot, electronic patient-reported outcomes (ePRO) modules, daily medication checklists, DoingLab Food Camera (AI diet photo calorie analysis), and Bluetooth linkage with the home InBody BWA ON analyzer. All data are managed under AWS cloud security standards (TLS/SSL encryption in transit, AWS KMS encryption at rest, and IAM/MFA access controls).
  2. InBody BWA ON (InBody Co., Ltd.; MFDS License No. 19-4025): A portable home-use bioelectrical impedance analyzer measuring segmental extracellular water (ECW) and total body water (TBW) to track upper limb fluid changes at home.
  3. InBody 770 (InBody Co., Ltd.; MFDS License No. 13-1188): An in-clinic multi-frequency bioelectrical impedance analyzer used during scheduled outpatient visits for reference clinical evaluation and paired calibration.

INTERVENTION PROTOCOLS [Cohort 1: Medication Adherence (N=200)]

  • Experimental Arm (n=100): Participants complete weekly ePRO surveys via the Pinkmate app. In addition, reporting adverse symptoms (e.g., fatigue, arthralgia) to the conversational Agentic AI chatbot immediately triggers targeted ePRO symptom questionnaires. If symptom severity worsens beyond predefined thresholds compared to prior records, the participant is automatically flagged on the clinician dashboard. Research coordinators and clinical staff monitor the dashboard daily (business days) and conduct proactive telephone consultations within 48 hours of flag detection to provide supportive care, symptom relief education, medication counseling, or expedited clinic referrals.
  • Control Arm (n=100): Participants use the Pinkmate app limited to basic medication reminders, daily check-in logs, and quarterly ePRO surveys (every 3 months). Automated AI chatbot symptom triggers, clinician dashboard flagging, and 48-hour proactive telephone interventions are disabled. Symptoms are managed during routine outpatient clinic visits.

[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.

  • Experimental Arm (n=32): Participants receive a loaned home InBody BWA ON device (loaned until December 31, 2028) and perform self-measurements at home at least twice weekly (daily recommended; on waking, post-voiding, identical clothing). Data are transmitted via Bluetooth to the clinician dashboard. Based on bioimpedance principles, dashboard alert flags are triggered when: (1) affected-arm ECW/TBW ratio increases by >= 0.010 from baseline, or (2) interlimb (affected/unaffected) ECW/TBW ratio reaches >= 1.020. When an alert persists for 3 consecutive days upon daily dashboard review, medical staff contact the patient by telephone within 48 hours to recommend intensive self-care (lymphatic drainage exercises) and an early outpatient visit.
  • Control Arm (n=32): Participants do not receive the home BWA ON device and undergo bioimpedance (InBody 770) and tape circumference measurements only at scheduled outpatient visits. App-based educational contents and scheduled PRO assessments are provided without continuous home bioimpedance linkage or dashboard alerts.
  • Standardized Clinical Rehabilitation Protocol (Common to Both Arms in Cohort 2):

Official clinical diagnosis and initiation of rehabilitation therapy are determined identically in both groups based on in-clinic InBody 770 and tape circumference measurements:

  1. Subclinical Lymphedema: Defined as a 5% to <10% limb volume increase from baseline (tape measure) OR an increase in affected-arm ECW/TBW ratio >= 0.010 from baseline (InBody 770). Managed with Class 2 compression sleeve and gauntlet for >= 12 hours/day for 4 weeks.
  2. Clinical Lymphedema: Defined as >= 10% limb volume increase from baseline (tape measure) OR affected-arm ECW/TBW ratio >= 0.395 (InBody 770). Managed with standardized rehabilitation therapy according to ISL stage (manual lymphatic drainage twice weekly, therapeutic exercises, compression garments/bandaging).

SAMPLE SIZE JUSTIFICATION AND STATISTICAL PLAN

  • Cohort 1: Assuming a 6-month mean PDC of 0.70 (SD 0.20) in the control group and 0.80 (SD 0.20) in the experimental group (effect size d = 0.50), 64 patients per arm are required for 80% power at a two-sided alpha of 0.05. Accounting for a ~20% dropout rate and annual surgical volume, 100 patients per arm (total N=200) will be enrolled.
  • Cohort 2: Assuming a 6-month mean increase in affected-arm ECW/TBW ratio of 0.010 (SD 0.012) in the control group versus 0.002 (SD 0.010) in the experimental group (effect size d = 0.72), 26 patients per arm are required for 80% power at a two-sided alpha of 0.05. Allowing for a 20% dropout rate, 32 patients per arm (total N=64) will be enrolled.
  • Primary analyses will be conducted on the Intention-to-Treat (ITT) population, with missing data handled by multiple imputation. An interim analysis for project KPI reporting is planned at 6 months after completion of enrollment or December 31, 2028; follow-up continues up to 60 months (until December 31, 2031).
Being tested
Cohort1: Pinkmate Agentic AI-ePRO Active Management Platform, Cohort1: Pinkmate Basic Medication Reminders and Standard Outpatient Care, Cohort2: InBody BWA ON Home Bioimpedance Monitoring and Behavioral App, Cohort2: Routine In-Clinic InBody 770 Monitoring and Educational App
Keywords
adjuvant endocrine therapy, proportion of days covered, axillary lymph node dissection, bioelectrical impedance analysis, electronic patient-reported outcomes, agentic ai, digital healthcare, InBody BWA ON, mobile application, tamoxifen, aromatase inhibitor
Medical subject headings
Medication Adherence, Carcinoma, Intraductal, Noninfiltrating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cohort1: Pinkmate Agentic AI-ePRO Active Management PlatformBehavioural

    Also called Pinkmate 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.

  • Cohort1: Pinkmate Basic Medication Reminders and Standard Outpatient CareOther

    Also called Standard care with basic 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.

  • Cohort2: InBody BWA ON Home Bioimpedance Monitoring and Behavioral AppDevice

    Also called InBody BWA ON (MFDS License No. 19-4025)

    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.

  • Cohort2: Routine In-Clinic InBody 770 Monitoring and Educational AppOther

    Also called Standard surveillance with InBody 770 (MFDS No. 13-1188)

    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.

Study groups in NCT07911839
Study groupRoleWhat they receive
Cohort 1 Experimental: Active AI and ePRO PlatformExperimentalParticipants 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.
Receives: Behavioral: Cohort1: Pinkmate Agentic AI-ePRO Active Management Platform
Cohort 1 Control: Standard Care with Basic AppActive comparatorParticipants 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.
Receives: Other: Cohort1: Pinkmate Basic Medication Reminders and Standard Outpatient Care
Cohort 2 Experimental: Home BWA ON Monitoring + AI AppExperimentalBreast 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.
Receives: Device: Cohort2: InBody BWA ON Home Bioimpedance Monitoring and Behavioral App
Cohort 2 Control: Routine In-Clinic InBody 770 MonitoringActive comparatorBreast 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.
Receives: Other: Cohort2: Routine In-Clinic InBody 770 Monitoring and Educational App

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At 6 months after intervention initiation

  2. 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.

    Measured: Baseline (enrollment) and 6 months after enrollment

  3. 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.

    Measured: Baseline (enrollment) and 6 months after enrollment

Secondary outcomes (6)

  1. 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).

    Measured: At 12, 24, 36, and 60 months after intervention initiation

  2. 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.

    Measured: Baseline, and at 3, 6, 12, 24, 36, and 60 months

  3. 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.

    Measured: Baseline, and at 3, 6, 12, 24, 36, and 60 months

  4. 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).

    Measured: At 6, 12, 24, 36, and 60 months after enrollment

  5. 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.

    Measured: Baseline, and at 6, 12, 24, 36, and 60 months after enrollment

  6. 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.

    Measured: At 12, 24, 36, and 60 months after intervention initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2026
  2. Study start29 Oct 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
Model description
Two independent randomized cohorts under a single master protocol. Cohort 1 evaluates medication adherence (1:1 randomization; 100 experimental vs 100 control). Cohort 2 evaluates lymphedema prevention (1:1 randomization; 32 experimental vs 32 control). Dual enrollment is permitted for patients meeting both criteria. Total target enrollment is 264 participants.
Masking
None (open label)
Enrolment
264 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07911839
Sponsor's protocol ID
KC26EISI0743
Acronym
Pinkmate
Status last verified
Oct 2026
First submitted
28 Oct 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Ridner SH, Dietrich MS, Boyages J, Koelmeyer L, Elder E, Hughes TM, French J, Ngui N, Hsu J, Abramson VG, Moore A, Shah C. A Comparison of Bioimpedance Spectroscopy or Tape Measure Triggered Compression Intervention in Chronic Breast Cancer Lymphedema Prevention. Lymphat Res Biol. 2022 Dec;20(6):618-628. doi: 10.1089/lrb.2021.0084. Epub 2022 Jan 28.

    PubMed 35099283

  • Karsten MM, Gebert P, Pross T, Hage AM, Dordevic AD, Stephan S, Kuhn F, Doppelbauer L, Blohmer JU, Fischer F, Rose M, Pohlmann A, Materne B, Petersen MA, Pauler L, Ferencz J, Wesselmann S, Breidenbach C, Grittner U, Kowalski C. Electronic Patient-Reported Outcome Monitoring With Alert-Based Interventions in Metastatic Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2026 Oct 1;12(10):1069-1078. doi: 10.1001/jamaoncol.2026.2661.

    PubMed 42560727

  • Shah C, Boyages J, Koelmeyer L, Chen SL, Vicini F. Timing of Breast Cancer Related Lymphedema Development Over 3 Years: Observations from a Large, Prospective Randomized Screening Trial Comparing Bioimpedance Spectroscopy (BIS) Versus Tape Measure. Ann Surg Oncol. 2024 Oct;31(11):7487-7495. doi: 10.1245/s10434-024-15706-x. Epub 2024 Jul 4.

    PubMed 38965099

Questions about this trial

What is this clinical trial studying?

A study testing Cohort1: Pinkmate Agentic AI-ePRO Active Management Platform, Cohort1: Pinkmate Basic Medication Reminders and Standard Outpatient Care and Cohort2: InBody BWA ON Home Bioimpedance Monitoring and Behavioral App in people with Breast Neoplasm Malignant Primary and Lymphedema Arm, run by Chang-Ik Yoon 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 16 inclusion and 9 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: opening soon, as of the sponsor's last update on 3 Nov 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chang-Ik Yoon, MD, PhD (+82-2-2258-6109, fayn03@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort1: Proportion of Days Covered (PDC) for Adjuvant Endocrine Therapy (time frame: At 6 months after intervention initiation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07911839, which also lists 3 linked publications.

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 3 Nov 2026.

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