Clinical trial · Interventional
Study Evaluating Flexitouch Plus With Connectivity on Compliance in 30 Patients With Breast Cancer-Related Lymphedema.
A Feasibility Study Evaluating the Impact Flexitouch Plus With Connectivity Has on Compliance in Patients With Breast Cancer-Related Lymphedema (BCRL)
NCT04432727CI-TRIAL-00066632completedN/AResults postedClinicalTrials.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 objective of this study is to demonstrate the feasibility of using the Flexitouch Plus with Cellular Connectivity (FT-CC) to monitor device use data to determine if reminders to patients impact compliance, and to identify the impact device compliance has on arm girth, quality of life (QOL), and symptom assessment.
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 Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Flexitouch Plus with Cellular Connectivity (FT-CC) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ACTIVE FT-CC
- description
- Text message reminders will be sent if subject does not use the device for 2 consecutive days.
- interventionNames
- Device: Flexitouch Plus with Cellular Connectivity (FT-CC)
- type
- EXPERIMENTAL
- label
- PASSIVE FT-CC
- description
- Text message reminders will not be sent to subjects.
- interventionNames
- Device: Flexitouch Plus with Cellular Connectivity (FT-CC)
Primary outcomes (1)
- measure
- Compliance Measured as the Average Number of Treatments Per Week
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female 18 years of age or older 2. Diagnosis of unilateral breast cancer-related lymphedema 3. Willing and able to give informed consent (remotely or in person) 4. Willing and able to comply with the study protocol requirements and all study-related visit requirements, including the ability to participate remotely 5. Willing and able to receive text messages from sponsor Exclusion Criteria: 1. In-home use of PCD within previous 3 months 2. Phase-one CDT within previous 1 month or planned phase-one CDT during study participation Phase-one CDT defined as professionally administered MLD and/or multi-layer short stretch compressive bandaging. 3. Inability to be fit for PCD garments 4. Heart failure (acute pulmonary edema, decompensated acute heart failure) 5. Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) 6. Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) on the arms or trunk 7. Currently receiving treatment for cancer with curative intent. 8. Any circumstance where increased lymphatic or venous return is undesirable 9. Currently pregnant or trying to become pregnant 10. Known inability to receive cell phone connection where FT-CC therapy will be administered
References
Publications (1)
- DERIVEDMaingi S, O'Malley EM. Impact of text reminders on pneumatic compression device (PCD) compliance in patients with breast cancer-related lymphedema. Support Care Cancer. 2023 Dec 16;32(1):33. doi: 10.1007/s00520-023-08246-9. PMID 38102530