RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-10-11
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05454189

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Hematology/Oncology patients ≥ 18 years old with an Implanted Port Device.
  2. * No planned clinical visits for at least 12 weeks.
  3. * 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.
  4. * No planned removal of IPD within 12 weeks of registration.
  5. * No Deep Vein Thrombosis or significant Implanted Port Device complication within ≤ 4 weeks of registration.
  6. * Patient Implanted Port Device with documented blood return ≤ 14 days of registration.
  7. * Ability to read and speak English.
  8. * Able to give informed consent.
  1. * Allergy to heparin
  2. * Vulnerable populations: pregnant women, prisoners, mentally handicapped.

Contacts and Locations

Study Contact

Bret Friday, MD, PhD
CONTACT
218-786-3625
bret.friday@essentiahealth.org
Tammie Mlodozyniec
CONTACT
218-786-1018
tammie.mlodozyniec@essentiahealth.org

Principal Investigator

Bret Friday, MD, PhD
PRINCIPAL_INVESTIGATOR
Essentia Health

Study Locations (Sites)

Mayo Clinic Health System - Albert Lea
Albert Lea, Minnesota, 56007
United States
Essentia Health St. Joseph's Medical Center
Brainerd, Minnesota, 56401
United States
Essentia Health Deer River Clinic
Deer River, Minnesota, 56636
United States
Essentia Health St Mary's Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501
United States
Essentia Health Duluth Clinic
Duluth, Minnesota, 55805
United States
Essentia Health Fosston
Fosston, Minnesota, 56542
United States
Fairview Grand Itasca Clinic & Hospital
Grand Rapids, Minnesota, 55744
United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
United States
Fairview Range Medical Center
Hibbing, Minnesota, 55746
United States
Mayo Clinic Health System - Mankato
Mankato, Minnesota, 56001
United States
Monticello Cancer center
Monticello, Minnesota, 55362
United States
Essentia Health Park Rapids
Park Rapids, Minnesota, 56470
United States
Fairview Northland Medical Center
Princeton, Minnesota, 55371
United States
Essentia Health Sandstone
Sandstone, Minnesota, 55072
United States
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
United States
Sanford Worthington Medical Center
Worthington, Minnesota, 56187
United States
Essentia Health Fargo
Fargo, North Dakota, 58103
United States

Collaborators and Investigators

Sponsor: Essentia Health

  • Bret Friday, MD, PhD, PRINCIPAL_INVESTIGATOR, Essentia Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-11
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2022-10-11
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Maintenance of Implanted Port Devices