Safety of Extending The Routine Flushing Of Implanted Port Devices From 4 Weeks To 12

Study Overview
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Brief Summary
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Implanted port devices (IPD) play an essential role in the safe administration of cancer treatments by providing a device to safely administer caustic chemotherapy agents. The current recommended frequency of flushing the IPD per manufacturers guidelines is every 4-6 weeks. The purpose of this study is to find out if extending IPD flushes to every 12 weeks is safe and if it is just as effective as every 4 week flushing.

Detailed Description
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After being informed about the study and potential risks, all participants giving written informed consent will complete port specific histories, assessments and questionnaires within 14 days prior to registration. Eligible, consented participants will be registered to the study and randomized to receive either IPD standard maintenance flushes and port assessments every 4 weeks or every 12 weeks for an initial 12 week interval. If study participants agree to the continuation portion of the study, they will continue to receive either IPD standard maintenance flushes and port assessments every 4 weeks or every 12 weeks for up to an additional three 12 week cycles.

Official Title
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A Prospective, Randomized Study To Evaluate The Safety of Extending The Routine Flushing Of Implanted Port Devices From 4 Weeks To 12 Weeks

Conditions
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Maintenance of Implanted Port Devices

Intervention / Treatment
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* Device: Reduced IPD Flush Schedule
* Device: Standard IPD Flush Schedule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hematology/Oncology patients ≥ 18 years old with an Implanted Port Device. No planned clinical visits for at least 12 weeks. No planned need to access Implanted Port Device within next 12 weeks outside of routine flushing. Potential reasons to access can include but are not limited to lab draw, infusion, IV contrast. No planned removal of IPD within 12 weeks of registration. No Deep Vein Thrombosis or significant Implanted Port Device complication within ≤ 4 weeks of registration. Patient Implanted Port Device with documented blood return ≤ 14 days of registration. Ability to read and speak English. Able to give informed consent. Exclusion Criteria: Allergy to heparin Vulnerable populations: pregnant women, prisoners, mentally handicapped.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a prospective, randomized study to determine the non-inferiority of every 12 week IPD flushes compared to every 4 week flushes in participants on an IPD maintenance flush schedule.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 4-week IPD Flushing Schedule<br>IPD standard maintenance flushes and port assessments every 4 weeks. | Device: Standard IPD Flush Schedule<br>* IPD flush every 4 weeks<br>|
| Experimental: 12-week IPD Flushing Schedule<br>IPD standard maintenance flushes and port assessments every 12 weeks. | Device: Reduced IPD Flush Schedule<br>* IPD flush every 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of IPD patency | IPD patency without major complication | 12 weeks post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term rate of IPD patency in scheduled 4-week versus 12-week IPD flushes at 24,36 and 48 weeks post randomization. | Rate of IPD patency during long term follow-up | Up to 48 weeks post randomization | 
| Difference in complication rates in scheduled 4-week versus 12-week IPD flushes at 12, 24,36 and 48 weeks post randomization. | Differences in specific complications such as occlusion, infection, mechanical as assessed by port assessments and adverse events | Up to 48 weeks post randomization | 
| Difference in healthcare and patient cost in scheduled 4-week versus 12-week IPD flushes | Determine healthcare and patient cost differences based documented participant charges and participant reported responses to a 8 question financial burden questionnaire. The questionnaire gathers demographic information about employment, method of payment, estimated costs, education level, and smoking status. | Up to 48 weeks post randomization | 
| Change in Participant Quality of Life and Satisfaction in Scheduled 4-week versus 12 week IPD flushes | Compare participant quality of life and satisfaction over time and between 4-week versus 12-week IPD flushes as assessed by participant responses to 7 question quality of life questionnaire. The questionnaire is specific to IPD flushing and uses a 5 point likert scale. | Up to 48 weeks post randomization | 
| Impact of smoking, participant age, IPD age, and concomitant medications on complication rates in scheduled 4-week versus 12 week IPD flushes. | Impact of smoking, participant age, IPD age, and concomitant medications on complication rates as assessed by participant response smoking status and port assessments and adverse events | Up to 48 weeks post randomization |