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Implementing a Tracking & Feedback Registry to Allay Cancer Therapy Disparities

21 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Implementing a Tracking & Feedback Registry to Allay Cancer Therapy Disparities

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 proven-effective
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 these circumstances was attributed to system failures rather than to provider or
patient factors. Such system failures occurred more often among minority women and among
women treated at hospitals serving predominantly minority patients. To target these system
failures at 6 NYC hospitals, 4 of which served predominantly minority patients, we used a
quasi-experimental pre-post test design to implement a tracking and feedback registry. The
Tracking and Feedback registry closed the referral loop between surgeons and oncologists,
increased the rate of completed oncology consultations, increased treatment rates and
eliminated the racial disparity in underuse. Its effects were greatest at the 4 hospitals
serving predominantly minority women, sites that had an EMR and patient navigation prior to
and during the T&F implementation. However, the trial was not randomized, tracking and
feedback functions were performed by study personnel and not embedded in the hospital's
workflow and details of what the surgeons did in response to the feedback was not assessed,
resulting in a call for more work in this area.

In this proposed randomized controlled trial, we will implement the Tracking and Feedback
(T&F) innovation in hospitals serving predominantly minority women. We will test the
effectiveness of the Tracking and Feedback registry innovation to increase rates of
completed oncology consultation, reduce underuse of needed adjuvant therapy and racial
disparities in receipt of these treatments. We will also assess the feasibility of
implementing a T&F Registry in these high-risk hospitals by evaluating implementation
effectiveness for this innovation. We have recruited 11 hospitals that serve large
proportions of minority women with breast cancer. We will randomize hospitals and will
recruit 540 women with a new breast cancer, 270 per intervention arm. We choose these "high
risk" hospitals because they serve predominantly minority populations, and such hospitals
have higher rates of the system failure cause of underuse, specifically, the type of
underuse targeted by our Tracking and Feedback Registry. We will: adapt existing
laptop-based Tracking & Feedback software to create a protected web-based format easily
accessible to all participating hospitals; tailor the Tracking & Feedback registry to each
of the participating hospitals' appropriate workflows including the areas of pathology,
surgery, medical and radiation oncology and tumor registry personnel in the process; and
embed the tracking and feedback tasks within existing hospital structures and personnel to
increase likelihood of sustainability beyond the grant. We will include in the web-based T&F
Registry an electronic data capture system to assess responses and actions to the tracking
information that is fed back to the surgeons. To assess the T&F Registry's effectiveness, we
will compare rates of underuse of patients treated at intervention versus control hospitals.
To assess implementation effectiveness at each hospital, we will assess process and outcomes
using qualitative and quantitative methods. Qualitatively, we will conduct pre- &
post-intervention interviews with key stakeholders to assess the implementation climate and
stakeholders' views of the Registry's utility. Quantitatively, we will measure and track
actions taken in response to the feedback information. As there is variability across
hospitals, we will also assess each hospital's treatment rates both pre- (N=540) and
post-intervention (N=540) to provide additional quantitative measures of implementation

Inclusion Criteria:

- 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 11 participating
hospitals in the NY Metropolitan Area.

- All surgeons performing breast surgery at study participating hospitals

Exclusion Criteria:

- Patients with a poor prognosis due to end-stage organ failure or other concomitant
conditions such as those undergoing treatment for other cancers

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

Change in intervention effect of adjuvant treatment

Outcome Description:

We will compare at initiation and completion of adjuvant treatment on all enrolled patients to determine the intervention's effect

Outcome Time Frame:

at baseline and at one year

Safety Issue:


Principal Investigator

Nina A Bickell, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai School of Medicine


United States: Institutional Review Board

Study ID:

GCO 09-1155



Start Date:

October 2012

Completion Date:

May 2015

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Treatment Disparities
  • Tracking and Feedback
  • Registry
  • Cancer Therapy Disparities
  • Adjuvant Treatment
  • Racial Disparities
  • Underuse of Adjuvant Treatment
  • Breast Neoplasms



Newark Beth Israel Medical Center Newark, New Jersey  07112
Elmhurst Hospital Center Elmhurst, New York  11373
Brooklyn Hospital Center Brooklyn, New York  11201
Montefiore Medical Center Bronx, New York  10467-2490
Lutheran Medical Center Brooklyn, New York  11220
Jacobi Medical Center Bronx, New York  10461
Queens Hospital Center Jamaica, New York  11432
Kings County Hospital Brooklyn, New York  11203
Metropolitan Hospital Center New York, New York  10029
Bronx-Lebanon Hospital Bronx, New York  10457
University Hospital of Brooklyn at Long Island College Hospital Brooklyn, New York  11201