Tracking & Feedback Registry to Reduce Breast Cancer Treatment Disparities
Implementing a Tracking & Feedback Registry to Allay Cancer Therapy Disparities
2 other identifiers
interventional
198
1 country
11
Brief Summary
Breast cancer is the second most common cause of cancer death in women. Black women are less likely than white women to develop breast cancer but, they are more likely to die of the disease. Some of this survival discrepancy is likely due to underuse of adjuvant therapies proven to increase survival. Breast cancer treatment often requires coordination among surgeons, pathologists, primary care physicians, medical and radiation oncologists. In NYC, black and Hispanic women who accessed care and underwent surgical treatment of their breast cancer were twice as likely as whites to experience underuse of adjuvant treatment. Disturbingly, 1/3 of these underuse cases were episodes in which the surgeon recommended treatment, the patient did not refuse and yet, care did not ensue. Underuse in such circumstances is attributable to system failures than to specific provider or patient factors. In this proposed randomized controlled trial, the investigators aim to test the effectiveness of a Tracking and Feedback (T\&F) registry innovation to increase rates of completed oncology consultation and reduce both underuse of needed adjuvant therapy and racial disparities in receipt of these treatments. The investigators also aim to assess the feasibility of implementing a T\&F Registry in these high-risk hospitals by evaluating implementation effectiveness for that innovation. The investigators have recruited 10 hospitals that serve large proportions of minority women with breast cancer. The investigators will randomize hospitals and aim to recruit 354 women with a new breast cancer, 177 per intervention arm. The investigators choose these "high risk" hospitals because they serve predominantly minority populations, and such hospitals have higher rates of the system failure cause of underuse, and particularly, the type of underuse targeted by our Tracking and Feedback Registry.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Oct 2012
Typical duration for not_applicable breast-cancer
11 active sites
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 13, 2012
CompletedFirst Posted
Study publicly available on registry
March 5, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedJune 9, 2016
June 1, 2016
3.6 years
February 13, 2012
June 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in intervention effect of adjuvant treatment
We will compare at initiation and completion of adjuvant treatment on all enrolled patients to determine the intervention's effect
at baseline and at one year
Secondary Outcomes (1)
Organizational Characteristics
at 5 years
Study Arms (2)
Tracking & Feedback
EXPERIMENTALSystems based intervention tracking oncology consultations and feeding back information to surgeons
Control- no intervention
NO INTERVENTIONUsual Care
Interventions
Systems based intervention tracking oncology consultations and feeding back information to surgeons
Eligibility Criteria
You may qualify if:
- All patients, who are English or Spanish speaking, with a new primary stage 1 or 2 and with tumors \> 1 cm or \< 1 cm and poorly differentiated breast cancer who have undergone either breast conserving surgery or mastectomy at 1 of 10 participating hospitals in the NY Metropolitan Area.
- All surgeons performing breast surgery at study participating hospitals
You may not qualify if:
- Patients with a poor prognosis due to end-stage organ failure or other concomitant conditions such as those undergoing treatment for other cancers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Newark Beth Israel Medical Center
Newark, New Jersey, 07052, United States
Brooklyn Hospital Center
Brooklyn, New York, 11201, United States
University Hospital of Brooklyn at Long Island College Hospital
Brooklyn, New York, 11201, United States
Kings County Hospital
Brooklyn, New York, 11203, United States
Lutheran Medical Center
Brooklyn, New York, 11209, United States
Elmhurst Hospital Center
Elmhurst, New York, 11373, United States
Queens Hospital Center
Jamaica, New York, 11433, United States
Metropolitan Hospital Center
New York, New York, 10029, United States
Bronx-Lebanon Hospital
The Bronx, New York, 10457, United States
Jacobi Medical Center
The Bronx, New York, 10461, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Related Publications (2)
Bickell NA, Shah A, Castaldi M, Lewis T, Sickles A, Arora S, Clarke K, Kemeny M, Srinivasan A, Fei K, Franco R, Parides M, Pappas P, McAlearney AS. Caution Ahead: Research Challenges of a Randomized Controlled Trial Implemented to Improve Breast Cancer Treatment at Safety-Net Hospitals. J Oncol Pract. 2018 Mar;14(3):e158-e167. doi: 10.1200/JOP.2017.026534. Epub 2018 Jan 3.
PMID: 29298115DERIVEDBickell NA, Moss AD, Castaldi M, Shah A, Sickles A, Pappas P, Lewis T, Kemeny M, Arora S, Schleicher L, Fei K, Franco R, McAlearney AS. Organizational Factors Affect Safety-Net Hospitals' Breast Cancer Treatment Rates. Health Serv Res. 2017 Dec;52(6):2137-2155. doi: 10.1111/1475-6773.12605. Epub 2016 Nov 14.
PMID: 27861833DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nina A Bickell, MD, MPH
Icahn School of Medicine Mount Sinai
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 13, 2012
First Posted
March 5, 2012
Study Start
October 1, 2012
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
June 9, 2016
Record last verified: 2016-06