Study Evaluating Flexitouch Plus With Connectivity on Compliance in 30 Patients With Breast Cancer-Related Lymphedema.

Not Applicable

Completed

• Conditions: Breast Cancer Lymphedema
• Interventions: Device: Flexitouch Plus with Cellular Connectivity (FT-CC)

• Registration Number: NCT04432727
• Lead Sponsor: Tactile Medical

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-06-08
• Study First Submitted QC: 2020-06-11
• Study First Posted: 2020-06-16
• Study Start: 2020-08-13
• Primary Completion: 2021-11-19
• Study Completion: 2021-11-19
• Results First Submitted: 2023-02-06
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-23
• Last Update Submitted: 2023-05-23
• Results First Posted: 2023-05-24
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PASSIVE FT-CC	Flexitouch Plus with Cellular Connectivity (FT-CC)	Text message reminders will not be sent to subjects.
ACTIVE FT-CC	Flexitouch Plus with Cellular Connectivity (FT-CC)	Text message reminders will be sent if subject does not use the device for 2 consecutive days.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Compliance With Device Use.	Through 60 days after device training	Analysis of compliance with prescribed device use.
Quality of Life Assessment Via LYMQOL ARM	Changes through 60 days after device training	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.
Quality of Life Assessment Via SF-36 Physical Functioning Domain Score	Changes through 60 days after device training	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.
Quality of Life Assessment Via LSIDS-A Score	Changes through 60 days after device training	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.

Trial Locations

Locations (3)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

St. Peter's Hospital; 🇺🇸 Albany, New York, United States

Samaritan Hospital Hildegard Medicus Cancer Center; 🇺🇸 Troy, New York, United States