REaCT-vascular Access Her2 Negative Vascular Access Strategies for (Neo) Adjuvant Breast Cancer Treatment Without Trastuzumab (OTT 15-07)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02688998|
Recruitment Status : Recruiting
First Posted : February 23, 2016
Last Update Posted : November 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Cancer||Device: venous access PORT or PICC||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Simple, Prospective and Randomized Trial to Obtain Answers to Questions of Standard of Care: Vascular Access Strategies for (Neo) Adjuvant Breast Cancer Treatment Without Trastuzumab: A Study From the REthinking Clinical Trials Program (REaCT-vascular Access Her2 Negative).|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
Active Comparator: Venous access PORT or PICC
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
Participants will receive a venous access prior to starting chemotherapy
No Intervention: No intervention
Participants will only receive a central line if required once chemotherapy has been initiated.
- Accrual rates [ Time Frame: 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 [ Time Frame: 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
- Physician engagement [ Time Frame: 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 [ Time Frame: One year ]2. Rates of documented thrombotic events need for anticoagulation, line infections, phlebitis, and extravasations during chemotherapy.
- Number of attempts at cannulation [ Time Frame: 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688998
|Contact: Mark Clemons, Dr.||613-737-7700 ext email@example.com|
|The Ottawa Hospital Cancer Centre||Recruiting|
|Ottawa, Ontario, Canada, K1H 8L6|
|Contact: Mark Clemons, Dr. 613-737-7700 ext 70170 firstname.lastname@example.org|