Clinical Feasibility of Mobile App-Based Self-Management for Breast Cancer-Related Lymphedema

NCT ID: NCT06922513

Last Updated: 2026-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-11

Study Completion Date

2025-10-21

Brief Summary

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The study evaluates a newly developed service that provides personalized self-management guidance based on evidence-based arm circumference measurements and resulting volume changes. The research aims to determine whether this digital solution is practical and acceptable for patients while identifying any unexpected challenges during implementation, ultimately establishing its potential for clinical integration into lymphedema care.

Detailed Description

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Conditions

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Breast Cancer Related Lymphedema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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digital health

Unilateral Upper Limb Lymphedema Associated with Breast Cancer

Group Type EXPERIMENTAL

digital health (Application and Smart Measuring Tape)

Intervention Type DEVICE

For lymphedema management, we use a smart measuring tape to measure arm circumference and provide analysis results along with self-management strategies.

Interventions

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digital health (Application and Smart Measuring Tape)

For lymphedema management, we use a smart measuring tape to measure arm circumference and provide analysis results along with self-management strategies.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Between 18 and 70 years of age
* Diagnosed with breast cancer-related unilateral upper limb lymphedema
* Possessing an Android or iOS smartphone
* Voluntarily deciding to participate and providing written consent after receiving a detailed explanation of this study

Exclusion Criteria

* Diagnosed with malignant lymphedema due to metastasis or recurrence
* Having severe comorbidities (underlying diseases, neuromusculoskeletal disorders, cognitive, mental, or visual impairments, etc.) that make it difficult to use the application and participate in exercise interventions

Discontinuation Criteria:

* Development of serious complications or cancer metastasis/recurrence during the study period
* Occurrence of a serious illness unrelated to study participation
* Failure to follow the instructions of the study physician
* Voluntary withdrawal from the study or development of circumstances preventing participation
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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JiHye Hwang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, Republic of Korea, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HA23C0423

Identifier Type: OTHER

Identifier Source: secondary_id

SMC 2024-04-011

Identifier Type: -

Identifier Source: org_study_id

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