Breast Cancer Lymphedema
Conditions
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.
Interventions
DEVICEFlexitouch Plus with Cellular Connectivity (FT-CC)
Daily use of FT-CC
Sponsors
Tactile Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ACTIVE FT-CC Text message reminders will be sent if subject does not use the device for 2 consecutive days.
Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC | 15 |
| PASSIVE FT-CC Text message reminders will not be sent to subjects.
Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC | 14 |
| Total | 29 |
Baseline characteristics
| Characteristic | ACTIVE FT-CC | Total | PASSIVE FT-CC |
|---|---|---|---|
| Age, Continuous | 52.3 years STANDARD_DEVIATION 10.8 | 54.9 years STANDARD_DEVIATION 10.4 | 57.7 years STANDARD_DEVIATION 9.7 |
| BMI | 33.1 kg/m^2 STANDARD_DEVIATION 8 | 32.8 kg/m^2 STANDARD_DEVIATION 7.6 | 32.4 kg/m^2 STANDARD_DEVIATION 7.4 |
| Dominant Hand Left | 1 Participants | 2 Participants | 1 Participants |
| Dominant Hand Right | 14 Participants | 27 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 26 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Height | 63.8 inches STANDARD_DEVIATION 2.3 | 63.1 inches STANDARD_DEVIATION 2.1 | 62.4 inches STANDARD_DEVIATION 1.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 23 Participants | 10 Participants |
| Region of Enrollment United States | 15 Participants | 29 Participants | 14 Participants |
| Sex: Female, Male Female | 15 Participants | 29 Participants | 14 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Weight | 190.9 pounds STANDARD_DEVIATION 42.8 | 185.2 pounds STANDARD_DEVIATION 42.1 | 179.1 pounds STANDARD_DEVIATION 42 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 14 |
| other Total, other adverse events | 4 / 15 | 5 / 14 |
| serious Total, serious adverse events | 0 / 15 | 1 / 14 |
Outcome results
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.
Time frame: 60 Days
Population: Patients who received text reminders vs. those that did not.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ACTIVE FT-CC | Compliance Measured as the Average Number of Treatments Per Week | 5.3 treatments/week | Standard Deviation 1.8 |
| PASSIVE FT-CC | Compliance Measured as the Average Number of Treatments Per Week | 5.2 treatments/week | Standard Deviation 2.1 |
Secondary
Compliance With Device Use.
Analysis of compliance with prescribed device use.
Time frame: Through 60 days after device training
Population: Subjects who were also seen 60 days post randomization.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ACTIVE FT-CC | Compliance With Device Use. | Partially Compliant (1-4 Days / Week) | 6 Participants |
| ACTIVE FT-CC | Compliance With Device Use. | Compliant (5-7 Days / Week) | 7 Participants |
| ACTIVE FT-CC | Compliance With Device Use. | Non-Compliant (<1 Day / Week) | 0 Participants |
| PASSIVE FT-CC | Compliance With Device Use. | Partially Compliant (1-4 Days / Week) | 4 Participants |
| PASSIVE FT-CC | Compliance With Device Use. | Non-Compliant (<1 Day / Week) | 1 Participants |
| PASSIVE FT-CC | Compliance With Device Use. | Compliant (5-7 Days / Week) | 5 Participants |
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.
Time frame: Changes through 60 days after device training
Population: All patients with follow-up through 60 days completing the LSIDS-A Questionnaire. A reduction in overall domain score change is considered to be positive.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ACTIVE FT-CC | Quality of Life Assessment Via LSIDS-A Score | Decrease in domain score change at 60 days | 12 Participants |
| ACTIVE FT-CC | Quality of Life Assessment Via LSIDS-A Score | No change in domain score at 60 days | 0 Participants |
| ACTIVE FT-CC | Quality of Life Assessment Via LSIDS-A Score | Increase in domain score change at 60 days. | 1 Participants |
| PASSIVE FT-CC | Quality of Life Assessment Via LSIDS-A Score | Decrease in domain score change at 60 days | 8 Participants |
| PASSIVE FT-CC | Quality of Life Assessment Via LSIDS-A Score | No change in domain score at 60 days | 0 Participants |
| PASSIVE FT-CC | Quality of Life Assessment Via LSIDS-A Score | Increase in domain score change at 60 days. | 3 Participants |
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.
Time frame: Changes through 60 days after device training
Population: Subjects completing the LYMQOL-ARM Tool at 60 days overall quality of life score 0-10 scale.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ACTIVE FT-CC | Quality of Life Assessment Via LYMQOL ARM | 7.6 score on a scale | Standard Deviation 2 |
| PASSIVE FT-CC | Quality of Life Assessment Via LYMQOL ARM | 6.6 score on a scale | Standard Deviation 1.7 |
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.
Time frame: Changes through 60 days after device training
Population: Patients with data through 60 days after device training. An increase in score reflects a positive outcome.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ACTIVE FT-CC | Quality of Life Assessment Via SF-36 Physical Functioning Domain Score | Decrease in general health domain scores at 60 days | 4 Participants |
| ACTIVE FT-CC | Quality of Life Assessment Via SF-36 Physical Functioning Domain Score | No change in general health domain scores at 60 days | 4 Participants |
| ACTIVE FT-CC | Quality of Life Assessment Via SF-36 Physical Functioning Domain Score | Increase in general health domain score change at 60 days | 6 Participants |
| PASSIVE FT-CC | Quality of Life Assessment Via SF-36 Physical Functioning Domain Score | Decrease in general health domain scores at 60 days | 8 Participants |
| PASSIVE FT-CC | Quality of Life Assessment Via SF-36 Physical Functioning Domain Score | No change in general health domain scores at 60 days | 0 Participants |
| PASSIVE FT-CC | Quality of Life Assessment Via SF-36 Physical Functioning Domain Score | Increase in general health domain score change at 60 days | 3 Participants |