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

Breast Cancer Lymphedema Clinical Trial

Official title:

A Feasibility Study Evaluating the Impact Flexitouch Plus With Connectivity Has on Compliance in Patients With Breast Cancer-Related Lymphedema (BCRL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04432727
• Other study ID #: 4090
• Status: Completed
• Phase: N/A
• Start date: August 13, 2020
• Est. completion date: November 19, 2021

Study information

• Verified date: May 2023
• Source: Tactile Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: November 19, 2021
• Est. primary completion date: November 19, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Neoplasms
• Lymphedema

Intervention

Device:
• Flexitouch Plus with Cellular Connectivity (FT-CC)
Daily use of FT-CC

Locations

Country	Name	City	State
United States	St. Peter's Hospital	Albany	New York
United States	University of Louisville	Louisville	Kentucky
United States	Samaritan Hospital Hildegard Medicus Cancer Center	Troy	New York

Sponsors (1)

Lead Sponsor	Collaborator
Tactile Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Compliance With Device Use.	Analysis of compliance with prescribed device use.	Through 60 days after device training
Secondary	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
Secondary	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
Secondary	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