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

NCT06922513 | Completed

• 2 other identifiers: SMC 2024-04-011HA23C0423
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer Related Lymphedema

Outcome Measures

Primary Outcomes (2)

• Usability and Acceptability

  Self-Developed Questionnaire A. One item on the necessity of a lymphedema self-management app B. 23 items on satisfaction and acceptability C. Scoring scale: 1 (Strongly Disagree) - 6 (Strongly Agree)

  Baseline, Month 3

• SUS

  Full Title: System Usability Scale A. A 10-item questionnaire to evaluate system usability B. Score range is 0-100, with a benchmark known to be 68 points Self-developed questionnaire

  Baseline, Month 3

Secondary Outcomes (9)

• TTM (Transtheoretical Model)

  Baseline, Month 3

• LYMQOL

  Baseline, Month 3

• EQ-5D-5L

  Baseline, Month 3

• self-efficacy

  Baseline, Month 3

• upper arm use

  Baseline, Month 3

Other Outcomes (1)

• GPAQ

  Baseline

Study Arms (1)

digital health

EXPERIMENTAL

Unilateral Upper Limb Lymphedema Associated with Breast Cancer

Device: digital health (Application and Smart Measuring Tape)

Interventions

digital health (Application and Smart Measuring Tape) DEVICE

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

digital health

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Republic of Korea, 06351, South Korea

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 10, 2025
• Study Start: April 11, 2025
• Primary Completion: October 21, 2025
• Study Completion: October 21, 2025
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)