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)

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Lymphedema
• Intervention / Treatment: Device: Flexitouch Plus with Cellular Connectivity (FT-CC)

Detailed Description

This is a multi-center, on label, prospective, randomized, two-arm feasibility study that plans to enroll 30 female subjects in the United States. In an effort to reduce potential exposure to COVID-19, all study assessments are intended to be performed in a contactless manner (i.e., telephone, video conference, etc). If a subject passes the initial screening requirements via medical history and expresses interest in the study an informed consent form will be provided to them. Once consent has been obtained they will undergo a baseline visit where they will be randomized to one of two treatment groups: PASSIVE FT-CC (text messages reminders will not be sent to subjects) and ACTIVE FT-CC (text messages reminders will be sent if subject does not use the device for 2 consecutive days). Randomization was incorporated into the study to determine if ACTIVE FT-CC affects device use. A total of 2 follow-up visits will be conducted over a 60-day period.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • New York
    • Albany, New York, United States, 12208
      • St. Peter's Hospital
    • Troy, New York, United States, 12180
      • Samaritan Hospital Hildegard Medicus Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACTIVE FT-CC; Text message reminders will be sent if subject does not use the device for 2 consecutive days.	Device: Flexitouch Plus with Cellular Connectivity (FT-CC); Daily use of FT-CC
Experimental: PASSIVE FT-CC; Text message reminders will not be sent to subjects.	Device: Flexitouch Plus with Cellular Connectivity (FT-CC); Daily use of FT-CC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance Measured as the Average Number of Treatments Per Week	Compare the rate of compliance in patients treated with PASSIVE FT-CC and ACTIVE FT-CC.	60 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance With Device Use.	Analysis of compliance with prescribed device use.	Through 60 days after device training
Quality of Life Assessment Via LYMQOL ARM	Comparison of quality of life in patients treated with Active FT-CC vs. Passive FT-CC via Lymphedema Quality of Life Tool (LYMQOL ARM). Lymphedema Quality of Life Tool (LYMQOL-ARM) includes sub-scores for Function (range 10-40), Appearance (range 5-20), Symptoms (range 6-24), and Emotion (range 6-24) where lower scores represent a better outcome. It also includes an Overall QOL sub-score (range 0-10) where a higher score represents a better outcome.	Changes through 60 days after device training
Quality of Life Assessment Via SF-36 Physical Functioning Domain Score	Comparison of baseline vs. 60-day follow-up results of the The RAND 36-Item Short Form Survey (SF-36). The RAND 36-Item Short Form Survey (SF-36) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item for perceived change in health. Min value: 0, Max value: 100. Higher scores represent a better outcome.	Changes through 60 days after device training
Quality of Life Assessment Via LSIDS-A Score	Comparison of baseline vs. 60-day follow-up results of the LSIDS-A Scoring Tool. The LSIDS-A domains consist of 30 questions in the areas of soft tissue sensation, neurological sensation, function, behavior, resource, sexuality, and activity. Scores are compiled by domain and overall. Overall results will be posted here.	Changes through 60 days after device training

Collaborators and Investigators

• Sponsor: Tactile Medical
• Investigators: Principal Investigator: Sarah Pesek, MD, St. Peter's Health Partners; Principal Investigator: Nicolas Ajkay, MD, University of Louisville

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2020
• Primary Completion (Actual): November 19, 2021
• Study Completion (Actual): November 19, 2021

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Postoperative Complications; Breast Diseases; Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
• Other Study ID Numbers: 4090 (OPD)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No