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NCT07911839

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

Sponsor: Chang-Ik Yoon

View on ClinicalTrials.gov

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 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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

264

Start Date

2026-10-29

Completion Date

2028-12-31

Last Updated

2026-11-03

Healthy Volunteers

Conditions

Breast Neoplasm Malignant Primary Lymphedema Arm Medication Adherence Ductal Carcinoma In Situ

Interventions

BEHAVIORAL

Cohort1: Pinkmate Agentic AI-ePRO Active Management Platform

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.

OTHER

Cohort1: Pinkmate Basic Medication Reminders and Standard Outpatient Care

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.

DEVICE

Cohort2: InBody BWA ON Home Bioimpedance Monitoring and Behavioral 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.

OTHER

Cohort2: Routine In-Clinic InBody 770 Monitoring and Educational App

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.

Inclusion Criteria: 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). * 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. Exclusion Criteria: * 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. * 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.

Locations (1)

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

Seoul, South Korea