Clinical trial · Interventional
Clinical Feasibility of Mobile App-Based Self-Management for Breast Cancer-Related Lymphedema
NCT06922513CI-TRIAL-00103002completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Related Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| digital health (Application and Smart Measuring Tape) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- digital health
- description
- Unilateral Upper Limb Lymphedema Associated with Breast Cancer
- interventionNames
- Device: digital health (Application and Smart Measuring Tape)
Primary outcomes (2)
- measure
- Usability and Acceptability
- timeFrame
- Baseline, Month 3
- description
- 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)
- measure
- SUS
- timeFrame
- Baseline, Month 3
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.