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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
400
IPD flush every 12 weeks
IPD flush every 4 weeks
Mayo Clinic Health System - Albert Lea
Albert Lea, Minnesota, United States
RECRUITINGRate of IPD patency
IPD patency without major complication
Time frame: 12 weeks post randomization
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Essentia Health St. Joseph's Medical Center
Brainerd, Minnesota, United States
RECRUITINGEssentia Health Deer River Clinic
Deer River, Minnesota, United States
RECRUITINGEssentia Health St Mary's Detroit Lakes Clinic
Detroit Lakes, Minnesota, United States
RECRUITINGEssentia Health Duluth Clinic
Duluth, Minnesota, United States
RECRUITINGEssentia Health Fosston
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RECRUITINGFairview Grand Itasca Clinic & Hospital
Grand Rapids, Minnesota, United States
RECRUITINGEssentia Health Hibbing Clinic
Hibbing, Minnesota, United States
RECRUITINGFairview Range Medical Center
Hibbing, Minnesota, United States
RECRUITINGMayo Clinic Health System - Mankato
Mankato, Minnesota, United States
RECRUITING...and 7 more locations
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
Time frame: Up to 48 weeks post randomization