Study Evaluating Flexitouch Plus With Connectivity on Compliance in 30 Patients With Breast Cancer-Related Lymphedema.
A Feasibility Study Evaluating the Impact Flexitouch Plus With Connectivity Has on Compliance in Patients With Breast Cancer-Related Lymphedema (BCRL)
1 other identifier
interventional
29
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2020
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2020
CompletedFirst Posted
Study publicly available on registry
June 16, 2020
CompletedStudy Start
First participant enrolled
August 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 19, 2021
CompletedResults Posted
Study results publicly available
May 24, 2023
CompletedMay 24, 2023
May 1, 2023
1.3 years
June 8, 2020
February 6, 2023
May 23, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
Compliance With Device Use.
Through 60 days after device training
Quality of Life Assessment Via LYMQOL ARM
Changes through 60 days after device training
Quality of Life Assessment Via SF-36 Physical Functioning Domain Score
Changes through 60 days after device training
Quality of Life Assessment Via LSIDS-A Score
Changes through 60 days after device training
Study Arms (2)
ACTIVE FT-CC
EXPERIMENTALText message reminders will be sent if subject does not use the device for 2 consecutive days.
PASSIVE FT-CC
EXPERIMENTALText message reminders will not be sent to subjects.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tactile Medicallead
Study Sites (3)
University of Louisville
Louisville, Kentucky, 40202, United States
St. Peter's Hospital
Albany, New York, 12208, United States
Samaritan Hospital Hildegard Medicus Cancer Center
Troy, New York, 12180, United States
Related Publications (1)
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.
PMID: 38102530DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Michelle Wetherby
- Organization
- Tactile Medical
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah Pesek, MD
St. Peter's Health Partners
- PRINCIPAL INVESTIGATOR
Nicolas Ajkay, MD
University of Louisville
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2020
First Posted
June 16, 2020
Study Start
August 13, 2020
Primary Completion
November 19, 2021
Study Completion
November 19, 2021
Last Updated
May 24, 2023
Results First Posted
May 24, 2023
Record last verified: 2023-05