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CompletedNCT01544374Updated Jun 9, 2016

Tracking & Feedback Registry to Reduce Breast Cancer Treatment Disparities

An interventional study of Tracking & Feedback in Breast Cancer, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 11 sites in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2016-06-09.

Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
198
Allocation
Randomized
Ages
21 Years and older
Sex
Female
01

Study 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.

Read the detailed description

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 10 hospitals that serve large proportions of minority women with breast cancer. We will randomize hospitals and will recruit 354 women with a new breast cancer, 177 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=354) to provide additional quantitative measures of implementation effectiveness.

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Conditions studied

  • Breast Cancer

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Keywords

  • Breast Cancer
  • Treatment Disparities
  • Tracking and Feedback
  • Registry
  • Cancer Therapy Disparities
  • Adjuvant Treatment
  • Racial Disparities
  • Underuse of Adjuvant Treatment
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 198 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.

Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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 10 participating hospitals in the NY Metropolitan Area.
  • All surgeons performing breast surgery at study participating hospitals

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
198 participants (actual)

Study arms

  • Experimental
    Tracking & Feedback

    Systems based intervention tracking oncology consultations and feeding back information to surgeons

    Other: Tracking & Feedback

  • No intervention
    Control- no intervention

    Usual Care

Interventions

  • OtherTracking & Feedback

    Systems based intervention tracking oncology consultations and feeding back information to surgeons

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What researchers measure

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

    Time frame: at baseline and at one year

Secondary outcomes

  1. Organizational Characteristics

    To describe the organizational characteristics and the implementation climate of the hospitals and their relationship to the hospitals' change in rates of guideline concordant adjuvant treatment pre- and post-intervention.

    Time frame: at 5 years

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Study locations

11 sites
  • Newark Beth Israel Medical Center
    Newark, New Jersey 07052, United States
  • Bronx-Lebanon Hospital
    Bronx, New York 10457, United States
  • Jacobi Medical Center
    Bronx, New York 10461, United States
  • Montefiore Medical Center
    Bronx, New York 10461, 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
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References and documents

Publications

  • 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. PubMed 29298115 ↗
  • Bickell 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. PubMed 27861833 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01544374
Lead sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Mar 5, 2012
Start date
Oct 2012
Primary completion
May 2016
Completion
May 2016
Last update
Jun 9, 2016

Study contacts

Nina A Bickell, MD, MPH
principal investigator · Icahn School of Medicine Mount Sinai

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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