Trial · NCT07911839
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
NCT07911839, Not applicable, Not yet recruiting, Chang-Ik Yoon
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors. Trials, record NCT07911839. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07911839
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
- NCT number
- NCT07911839
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 264 participants, estimated
- Lead sponsor
- Chang-Ik Yoon
- Conditions
- Breast Neoplasm Malignant Primary, Lymphedema Arm, Medication Adherence, Ductal Carcinoma In Situ
- Interventions
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
- First posted
- 2026-11-03
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cohort1: Proportion of Days Covered (PDC) for Adjuvant Endocrine Therapy | At 6 months after intervention initiation | 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. |
| Primary | Cohort2: Percentage Change from Baseline in Affected Upper Limb Volume | Baseline (enrollment) and 6 months after enrollment | 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. |
| Primary | Cohort2: Change from Baseline in Affected Upper Limb ECW/TBW Ratio | Baseline (enrollment) and 6 months after enrollment | 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. |
| Secondary | Cohort1: Long-Term Proportion of Days Covered (PDC) for Adjuvant Endocrine Therapy | At 12, 24, 36, and 60 months after intervention initiation | 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). |
| Secondary | Cohort1: Change from Baseline in Functional Assessment of Cancer Therapy - Breast (FACT-B) Score | Baseline, and at 3, 6, 12, 24, 36, and 60 months | 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. |
| Secondary | Cohort1: Change from Baseline in Endocrine Therapy-Related Symptom PRO T-scores | Baseline, and at 3, 6, 12, 24, 36, and 60 months | Standardized ePRO symptom T-scores for key endocrine therapy-associated adverse symptoms (including fatigue and arthralgia) collected via the mobile application. |
| Secondary | Cohort2: Cumulative Incidence of Subclinical and Clinical Upper Limb Lymphedema | At 6, 12, 24, 36, and 60 months after enrollment | 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). |
| Secondary | Cohort2: Progression of International Society of Lymphology (ISL) Lymphedema Stage | Baseline, and at 6, 12, 24, 36, and 60 months after enrollment | Proportion of participants experiencing progression from ISL Stage 1 to Stage 2 or higher based on clinical evaluation by a rehabilitation medicine specialist. |
| Secondary | Both Cohorts: System Usability Scale (SUS) Score for Pinkmate Mobile Application | At 12, 24, 36, and 60 months after intervention initiation | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07911839
GET https://conductscience.org/api/trials/v1/NCT07911839/registered