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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACTIVE FT-CC | Experimental | Text message reminders will be sent if subject does not use the device for 2 consecutive days. |
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| PASSIVE FT-CC | Experimental | Text message reminders will not be sent to subjects. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flexitouch Plus with Cellular Connectivity (FT-CC) | Device | Daily use of FT-CC |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance With Device Use. | Analysis of compliance with prescribed device use. | Through 60 days after device training |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Pesek, MD | St. Peter's Health Partners | Principal Investigator |
| Nicolas Ajkay, MD | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville | Louisville | Kentucky | 40202 | United States | ||
| St. Peter's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38102530 | Derived | Maingi S, O'Malley EM. Impact of text reminders on pneumatic compression device (PCD) compliance in patients with breast cancer-related lymphedema. Support Care Cancer. 2023 Dec 16;32(1):33. doi: 10.1007/s00520-023-08246-9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | PASSIVE FT-CC |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 11, 2021 |
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| Changes through 60 days after device training |
| 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 |
| 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 |
| Albany |
| New York |
| 12208 |
| United States |
| Samaritan Hospital Hildegard Medicus Cancer Center | Troy | New York | 12180 | United States |
Text message reminders will not be sent to subjects.
Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | PASSIVE FT-CC | Text message reminders will not be sent to subjects. Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | pounds |
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| Height | Mean | Standard Deviation | inches |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Dominant Hand | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Patients who received text reminders vs. those that did not. | Posted | Mean | Standard Deviation | treatments/week | 60 Days |
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| Secondary | Compliance With Device Use. | Analysis of compliance with prescribed device use. | Subjects who were also seen 60 days post randomization. | Posted | Count of Participants | Participants | Through 60 days after device training |
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| 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. | Subjects completing the LYMQOL-ARM Tool at 60 days overall quality of life score 0-10 scale. | Posted | Mean | Standard Deviation | score on a scale | Changes through 60 days after device training |
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| 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. | Patients with data through 60 days after device training. An increase in score reflects a positive outcome. | Posted | Count of Participants | Participants | Changes through 60 days after device training |
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| 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. | 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. | Posted | Count of Participants | Participants | Changes through 60 days after device training |
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Adverse event data were collected from the point of randomization through study exit (Day 60).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 15 | 0 | 15 | 4 | 15 |
| EG001 | PASSIVE FT-CC | Text message reminders will not be sent to subjects. Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC | 0 | 14 | 1 | 14 | 5 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute pyelonephritis | Infections and infestations | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clicking in right thumb joint | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Bilateral buttock pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Exacerbation of lymphedema related pain right arm | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Suspected cellulitis | Infections and infestations | Systematic Assessment |
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| Trauma secondary to fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Lymphedema exacerbation | Blood and lymphatic system disorders | Systematic Assessment |
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| Progressive disease right axilla | Blood and lymphatic system disorders | Systematic Assessment |
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| Swelling under right arm due to weight gain, no lymphedema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sinus infection | Infections and infestations | Systematic Assessment |
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| Increased lung nodule from 2011 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Tender in armpit when using device | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Worsening lymphedema (mild) | Blood and lymphatic system disorders | Systematic Assessment |
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| Maculo-papular rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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The COVID-19 pandemic resulted in the closure of several clinics and when clinics were able to resume operations, it was on a limited basis to keep patients and providers physically distanced from others. In addition, reduction of staff impacted research conduct. Finally, patients were often not willing to attend study visits. These factors all contributed to slow enrollment and a high early withdrawal rate which led to the decision to discontinue the study.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Wetherby | Tactile Medical | 612-230-4576 | mwetherby@tactilemedical.com |
| May 10, 2022 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000072656 | Breast Cancer Lymphedema |
| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Right |
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