Maintenance of Implanted Port Devices
Conditions
Brief summary
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
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.
Interventions
DEVICEReduced IPD Flush Schedule
IPD flush every 12 weeks
DEVICEStandard IPD Flush Schedule
IPD flush every 4 weeks
Sponsors
Essentia Health
Minnesota Cancer Clinical Trials Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of IPD patency | 12 weeks post randomization | IPD patency without major complication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long-term rate of IPD patency in scheduled 4-week versus 12-week IPD flushes at 24,36 and 48 weeks post randomization. | Up to 48 weeks post randomization | Rate of IPD patency during long term follow-up |
| Difference in complication rates in scheduled 4-week versus 12-week IPD flushes at 12, 24,36 and 48 weeks post randomization. | Up to 48 weeks post randomization | Differences in specific complications such as occlusion, infection, mechanical as assessed by port assessments and adverse events |
| Difference in healthcare and patient cost in scheduled 4-week versus 12-week IPD flushes | Up to 48 weeks post randomization | 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. |
| Change in Participant Quality of Life and Satisfaction in Scheduled 4-week versus 12 week IPD flushes | Up to 48 weeks post randomization | 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. |
| Impact of smoking, participant age, IPD age, and concomitant medications on complication rates in scheduled 4-week versus 12 week IPD flushes. | Up to 48 weeks post randomization | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBret Friday, MD, PhD
Essentia Health
Outcome results
None listed