REaCT-vascular Access Her2 Negative Vascular Access Strategies for (Neo) Adjuvant Breast Cancer Treatment Without Trastuzumab

Not Applicable

Completed

• Conditions: Breast Cancer; Cancer
• Interventions: Device: venous access PORT or PICC

• Registration Number: NCT02688998
• Lead Sponsor: Ottawa Hospital Research Institute

Brief Summary

In the REaCT-Vascular Access Her2 negative study, the investigator will use a novel method to allow comparisons of established standard of care vascular access strategies using the "integrated consent model" as part of a pragmatic clinical trial.

Determining the optimal vascular access strategy remains an important medical issue for patients, nurses, physicians and society. A novel method to allow comparison of established standards of care is needed as part of an increasing internationally mandated incentive to perform more pragmatic clinic trials.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-18
• Study First Submitted QC: 2016-02-18
• Study First Posted: 2016-02-23
• Study Start: 2016-04
• Primary Completion: 2019-02
• Study Completion: 2019-02
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• Histologically confirmed primary breast cancer
• Planned to start either FEC-D, AC-D, dose-dense AC-T, TAC, or TC chemotherapy, in the adjuvant or neoadjuvant setting.
• ≥19 years of age
• Able to provide verbal consent

Exclusion Criteria

• Contraindication to central line placement.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Venous access PORT or PICC	venous access PORT or PICC	Participants will receive a central line placement either a PORT or a PICC prior to the initiation of chemotherapy.

Primary Outcome Measures

Name	Time	Method
Accrual rates	One year	Percentage of patients who receive (neo)adjuvant IV systemic therapy for Her 2 negative breast cancer compared to the number of participants who agree to randomization. The total number of new patients receiving (neo) adjuvant IV systemic cytotoxic therapy will be provided by the local chemotherapy pharmacy and Oncology Patient Information System records.
Patient compliance	One year	Percentage of participants who are randomized who accept randomization, and percentage of patients who cross-over to receive a central line while on study will be calculated using the chemotherapy treatment documentation in the designated hospital electronic patient record program

Secondary Outcome Measures

Name	Time	Method
Physician engagement	One year	Percentage of medical oncologists who have agreed to participate in the trial compared to the percentage who approached patients regarding the trial.
Rates of thrombotic events	One year	2. Rates of documented thrombotic events need for anticoagulation, line infections, phlebitis, and extravasations during chemotherapy.
Number of attempts at cannulation	One year	3. For those patients randomised to peripheral access information on the number of attempts at cannulation will be collected and site of cannulation. (ipsilateral to surgery vs contralateral to surgery)

Trial Locations

Locations (1)

The Ottawa Hospital Cancer Centre; 🇨🇦 Ottawa, Ontario, Canada