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Completed

NCT Number: NCT02173262

REaCT Integrated Consent Model to Compare Two Standard of Care Regimens

The Integrated Consent Model is being increasingly used internationally to improve patient care. In this feasibility study we will explore whether the model is feasible in practice; and whether it can be used to increase the number of physicians and patients who take part in clinical trials, and address the critical issue around the optimal febrile neutropenia prevention by randomizing eligible patients to either G-CSF or ciprofloxacin.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed primary breast cancer
  • Planned TC chemotherapy
  • ≥19 years of age
  • Able to provide verbal consent
  • Willing to complete a survey

Exclusion criteria

  • Contraindication to either Ciprofloxacin or G-CSF

Treatment and study plan

G-CSF

Drug

Other names: granulocyte-colony stimulating factor

Ciprofloxacin

Drug

Other names: Cipro, Cipro XR, Proquin XR

Primary outcomes

  1. The percentage of randomized patients in each physician's practice

    Time frame: every 4 weeks up to 2 years

    The percentage of randomized patients will be measured by collecting reasons for NOT complying with, or "opting-out" of the randomized selection compared to the overall accrual.

Secondary outcomes

  1. rates of febrile neutropenia

    Time frame: Once when the last participant completes chemotherapy up to year 2

    Rates of febrile neutropenia will be compared between Ciprofloxacin and G-CSF

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study title

Feasibility of Using an Integrated Consent Model to Compare Two Standard of Care Regimens for Primary Prophylaxis of Taxotere/Cyclophosphamide-Induces Febrile Neutropenia

Acronym: OTT14-03

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 24, 2014
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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