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

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Samsung Medical Center

Status

Not yet enrolling

Conditions

Breast Cancer Related Lymphedema

Treatments

Device: digital health (Application and Smart Measuring Tape)

Study type

Interventional

Funder types

Other

Identifiers

NCT06922513
HA23C0423 (Other Identifier)
SMC 2024-04-011

Details and patient eligibility

About

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.

Enrollment

58 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

58 participants in 1 patient group

digital health
Experimental group
Description:
Unilateral Upper Limb Lymphedema Associated with Breast Cancer
Treatment:
Device: digital health (Application and Smart Measuring Tape)

Trial contacts and locations

1

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Central trial contact

Sun Woo Kim

Data sourced from clinicaltrials.gov

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