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

Primary Purpose

Breast Cancer Lymphedema

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Flexitouch Plus with Cellular Connectivity (FT-CC)
Sponsored by
Tactile Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Lymphedema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Louisville
  • St. Peter's Hospital
  • Samaritan Hospital Hildegard Medicus Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ACTIVE FT-CC

PASSIVE FT-CC

Arm Description

Text message reminders will be sent if subject does not use the device for 2 consecutive days.

Text message reminders will not be sent to subjects.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Compliance With Device Use.
Analysis of compliance with prescribed device use.
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.
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.
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.

Full Information

First Posted
June 8, 2020
Last Updated
May 23, 2023
Sponsor
Tactile Medical
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1. Study Identification

Unique Protocol Identification Number
NCT04432727
Brief Title
Study Evaluating Flexitouch Plus With Connectivity on Compliance in 30 Patients With Breast Cancer-Related Lymphedema.
Official Title
A Feasibility Study Evaluating the Impact Flexitouch Plus With Connectivity Has on Compliance in Patients With Breast Cancer-Related Lymphedema (BCRL)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 13, 2020 (Actual)
Primary Completion Date
November 19, 2021 (Actual)
Study Completion Date
November 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tactile Medical

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Lymphedema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACTIVE FT-CC
Arm Type
Experimental
Arm Description
Text message reminders will be sent if subject does not use the device for 2 consecutive days.
Arm Title
PASSIVE FT-CC
Arm Type
Experimental
Arm Description
Text message reminders will not be sent to subjects.
Intervention Type
Device
Intervention Name(s)
Flexitouch Plus with Cellular Connectivity (FT-CC)
Intervention Description
Daily use of FT-CC
Primary Outcome Measure Information:
Title
Compliance Measured as the Average Number of Treatments Per Week
Description
Compare the rate of compliance in patients treated with PASSIVE FT-CC and ACTIVE FT-CC.
Time Frame
60 Days
Secondary Outcome Measure Information:
Title
Compliance With Device Use.
Description
Analysis of compliance with prescribed device use.
Time Frame
Through 60 days after device training
Title
Quality of Life Assessment Via LYMQOL ARM
Description
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.
Time Frame
Changes through 60 days after device training
Title
Quality of Life Assessment Via SF-36 Physical Functioning Domain Score
Description
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.
Time Frame
Changes through 60 days after device training
Title
Quality of Life Assessment Via LSIDS-A Score
Description
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.
Time Frame
Changes through 60 days after device training

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female 18 years of age or older Diagnosis of unilateral breast cancer-related lymphedema Willing and able to give informed consent (remotely or in person) Willing and able to comply with the study protocol requirements and all study-related visit requirements, including the ability to participate remotely Willing and able to receive text messages from sponsor Exclusion Criteria: In-home use of PCD within previous 3 months 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. Inability to be fit for PCD garments Heart failure (acute pulmonary edema, decompensated acute heart failure) Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) on the arms or trunk Currently receiving treatment for cancer with curative intent. Any circumstance where increased lymphatic or venous return is undesirable Currently pregnant or trying to become pregnant Known inability to receive cell phone connection where FT-CC therapy will be administered
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Pesek, MD
Organizational Affiliation
St. Peter's Health Partners
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicolas Ajkay, MD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
St. Peter's Hospital
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Samaritan Hospital Hildegard Medicus Cancer Center
City
Troy
State/Province
New York
ZIP/Postal Code
12180
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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