Study Evaluating Flexitouch Plus With Connectivity on Compliance in 30 Patients With Breast Cancer-Related Lymphedema.
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Compliance [Changes between 30 days after device training and 60 days after device training]
Compare the rate of compliance (defined as the number of days device used/total study days) in patients treated with PASSIVE FT-CC and ACTIVE FT-CC.
Secondary Outcome Measures
- Change in Arm Girth [Changes between baseline, 30 days after device training, and 60 days after device training]
Comparison of partially compliant and compliant arm girth in patients treated with FT-CC. Arm girth is measured in cm.
- Quality of Life Assessment via LYMQOL ARM [Changes between baseline, 30 days after device training, and 60 days after device training]
Comparison of partially compliant and compliant quality of life in patients treated with 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 [Changes between baseline, 30 days after device training, and 60 days after device training]
Comparison of partially compliant and compliant quality of life in patients treated with FT-CC by via 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.
- Symptoms Assessment via LSIDS-A [Changes between baseline, 30 days after device training, and 60 days after device training]
Comparison of partially compliant and compliant symptoms in patients treated with FT-CC by via The Lymphedema Symptom Intensity and Distress Survey-ARM (LSIDS-A). The Lymphedema Symptom Intensity and Distress Survey is a questionnaire used to assess intensity and distress of symptoms in patients with lymphedema of the arm. This includes sub-scores for soft tissue sensation (range 0-10), neurological sensation (0-10), function, (0-10), biobehavioral (0-10), resource (0-10), sexuality (0-10), activity (0-10). Higher score represents worse outcome.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female 18 years of age or older
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Diagnosis of unilateral breast cancer-related lymphedema
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Willing and able to give informed consent (remotely or in person)
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Willing and able to comply with the study protocol requirements and all study-related visit requirements, including the ability to participate remotely
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Willing and able to receive text messages from sponsor
Exclusion Criteria:
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In-home use of PCD within previous 3 months
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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.
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Inability to be fit for PCD garments
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Heart failure (acute pulmonary edema, decompensated acute heart failure)
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Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
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Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) on the arms or trunk
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Currently receiving treatment for cancer with curative intent.
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Any circumstance where increased lymphatic or venous return is undesirable
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Currently pregnant or trying to become pregnant
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Known inability to receive cell phone connection where FT-CC therapy will be administered
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Louisville | Louisville | Kentucky | United States | 40202 |
| 2 | St. Peter's Hospital | Albany | New York | United States | 12208 |
| 3 | Samaritan Hospital Hildegard Medicus Cancer Center | Troy | New York | United States | 12180 |
Sponsors and Collaborators
- Tactile Medical
Investigators
- Principal Investigator: Sarah Pesek, MD, St. Peter's Health Partners
- Principal Investigator: Nicolas Ajkay, MD, University of Louisville
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 4090