NCT02688998

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 23, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

2.8 years

First QC Date

February 18, 2016

Last Update Submit

September 3, 2019

Conditions

Breast CancerCancer

Keywords

HER2 negative

Outcome Measures

Primary Outcomes (2)

  • Accrual rates

    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.

    One year

  • Patient compliance

    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

    One year

Secondary Outcomes (3)

  • Physician engagement

    One year

  • Rates of thrombotic events

    One year

  • Number of attempts at cannulation

    One year

Study Arms (2)

Venous access PORT or PICC

ACTIVE COMPARATOR

Participants will receive a central line placement either a PORT or a PICC prior to the initiation of chemotherapy.

Device: venous access PORT or PICC

No intervention

NO INTERVENTION

Participants will only receive a central line if required once chemotherapy has been initiated.

Interventions

venous access PORT or PICCDEVICE

Participants will receive a venous access prior to starting chemotherapy

Venous access PORT or PICC

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Contraindication to central line placement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (1)

  • Robinson A, Stober C, Fergusson D, Kehoe A, Bedard D, MacDonald F, Brunet MC, Saunders D, Mazzarello S, Vandermeer L, Joy AA, Awan A, Basulaiman B, Mallick R, Hutton B, Clemons M; REaCT investigators. A multicentre, randomized pilot trial comparing vascular access strategies for early stage breast cancer patients receiving non-trastuzumab containing chemotherapy. Breast Cancer Res Treat. 2019 Nov;178(2):337-345. doi: 10.1007/s10549-019-05388-5. Epub 2019 Aug 7.

    PMID: 31392518DERIVED

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Interventions

Catheterization, Peripheral

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2016

First Posted

February 23, 2016

Study Start

April 1, 2016

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

September 6, 2019

Record last verified: 2019-09

Locations

CA(1)