Breast Cancer LymphedemaNCT04432727
Study Evaluating Flexitouch Plus With Connectivity on Compliance in 30 Patients With Breast Cancer-Related Lymphedema.
A study testing Flexitouch Plus with Cellular Connectivity (FT-CC) in people with Breast Cancer Lymphedema, run by Tactile Medical at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Lymphedema
- What is being tested?
- Flexitouch Plus with Cellular Connectivity (FT-CC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Aug 2020to 19 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
St. Peter's Hospital
Albany, New York, 12208
University of Louisville
Louisville, Kentucky, 40202
Samaritan Hospital Hildegard Medicus Cancer Center
Troy, New York, 12180
About this study
Official title: A Feasibility Study Evaluating the Impact Flexitouch Plus With Connectivity Has on Compliance in Patients With Breast Cancer-Related Lymphedema (BCRL)
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.
Read the 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.
- Conditions
- Breast Cancer Lymphedema
- Being tested
- Flexitouch Plus with Cellular Connectivity (FT-CC)
- Medical subject headings
- Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexitouch Plus with Cellular Connectivity (FT-CC)Device
Daily use of FT-CC
| Study group | Role | What they receive |
|---|---|---|
| ACTIVE FT-CC | Experimental | Text message reminders will be sent if subject does not use the device for 2 consecutive days. Receives: Device: Flexitouch Plus with Cellular Connectivity (FT-CC) |
| PASSIVE FT-CC | Experimental | Text message reminders will not be sent to subjects. Receives: Device: Flexitouch Plus with Cellular Connectivity (FT-CC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 Days
Secondary outcomes (4)
Compliance With Device Use.
Analysis of compliance with prescribed device use.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Changes through 60 days after device training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start13 Aug 2020
- Primary completion19 Nov 2021
- Study completion19 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tactile Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Pesek, MD, Principal investigator, St. Peter's Health PartnersNicolas Ajkay, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432727
- Sponsor's protocol ID
- 4090
- Status last verified
- May 2023
- First submitted
- 8 Jun 2020
- Last updated
- 24 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 38102530
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Evaluating the Impact Flexitouch Plus With Connectivity Has on Compliance in Patients With Breast Cancer-Related Lymphedema (BCRL)
- ClinicalTrials.gov ID
- NCT04432727
- Acronym / sponsor ID
- 4090
- Conditions
- Breast Cancer Lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Tactile MedicalIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Posted 24 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACTIVE FT-CC | Experimental | Device: Flexitouch Plus with Cellular Connectivity (FT-CC)Text message reminders will be sent if subject does not use the device for 2 consecutive days. |
| PASSIVE FT-CC | Experimental | Device: Flexitouch Plus with Cellular Connectivity (FT-CC)Text message reminders will not be sent to subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flexitouch Plus with Cellular Connectivity (FT-CC)Daily use of FT-CC | Device | ACTIVE FT-CC, PASSIVE FT-CC |
Primary outcome
Compliance Measured as the Average Number of Treatments Per Week
Time frame: 60 Days
Compare the rate of compliance in patients treated with PASSIVE FT-CC and ACTIVE FT-CC.
4 secondary outcomes
Compliance With Device Use.
Time frame: Through 60 days after device training
Quality of Life Assessment Via LYMQOL ARM
Time frame: Changes through 60 days after device training
Quality of Life Assessment Via SF-36 Physical Functioning Domain Score
Time frame: Changes through 60 days after device training
Quality of Life Assessment Via LSIDS-A Score
Time frame: Changes through 60 days after device training
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38102530Maingi 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Pesek, MD principal investigator
St. Peter's Health Partners
Nicolas Ajkay, MD principal investigator
University of Louisville
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexitouch Plus with Cellular Connectivity (FT-CC) in people with Breast Cancer Lymphedema, run by Tactile Medical at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance Measured as the Average Number of Treatments Per Week (time frame: 60 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04432727, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.