Breast CancerNCT01544374
Tracking & Feedback Registry to Reduce Breast Cancer Treatment Disparities
A study testing Tracking & Feedback in people with Breast Cancer, run by Icahn School of Medicine at Mount Sinai at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tracking & Feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 11 sitesUnited States
- Study dates
- Oct 2012to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with a poor prognosis due to end-stage organ failure or other concomitant conditions such as those undergoing treatment for other cancers
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Brooklyn Hospital Center
Brooklyn, New York, 11201
University Hospital of Brooklyn at Long Island College Hospital
Brooklyn, New York, 11201
Kings County Hospital
Brooklyn, New York, 11203
Lutheran Medical Center
Brooklyn, New York, 11209
Elmhurst Hospital Center
Elmhurst, New York, 11373
Queens Hospital Center
Jamaica, New York, 11433
Metropolitan Hospital Center
New York, New York, 10029
Newark Beth Israel Medical Center
Newark, New Jersey, 07052
Bronx-Lebanon Hospital
The Bronx, New York, 10457
Jacobi Medical Center
The Bronx, New York, 10461
Montefiore Medical Center
The Bronx, New York, 10461
About this study
Official title: 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 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.
- Conditions
- Breast Cancer
- Being tested
- Tracking & Feedback
- Keywords
- Breast Cancer, Treatment Disparities, Tracking and Feedback, Registry, Cancer Therapy Disparities, Adjuvant Treatment, Racial Disparities, Underuse of Adjuvant Treatment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracking & FeedbackOther
Systems based intervention tracking oncology consultations and feeding back information to surgeons
| Study group | Role | What they receive |
|---|---|---|
| Tracking & Feedback | Experimental | Systems based intervention tracking oncology consultations and feeding back information to surgeons Receives: Other: Tracking & Feedback |
| Control- no intervention | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Nina A Bickell, MD, MPH, Principal investigator, Icahn School of Medicine Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544374
- Sponsor's protocol ID
- GCO 09-1155
- Other IDs
- 5R01CA149025
- Status last verified
- Jun 2016
- First submitted
- 13 Feb 2012
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
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 29298115Bickell 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Tracking & Feedback Registry to Allay Cancer Therapy Disparities
- ClinicalTrials.gov ID
- NCT01544374
- Acronym / sponsor ID
- GCO 09-1155
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Treatment Disparities, Tracking and Feedback, Registry, Cancer Therapy Disparities, Adjuvant Treatment, Racial Disparities, Underuse of Adjuvant Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 5 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tracking & Feedback | Experimental | Other: Tracking & FeedbackSystems based intervention tracking oncology consultations and feeding back information to surgeons |
| Control- no intervention | No intervention | –Usual Care |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with a poor prognosis due to end-stage organ failure or other concomitant conditions such as those undergoing treatment for other cancers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tracking & FeedbackSystems based intervention tracking oncology consultations and feeding back information to surgeons | Other | Tracking & Feedback |
Primary outcome
Change in intervention effect of adjuvant treatment
Time frame: at baseline and at one year
We will compare at initiation and completion of adjuvant treatment on all enrolled patients to determine the intervention's effect
1 secondary outcome
Organizational Characteristics
Time frame: at 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
- Derived from this study: PubMed 29298115Bickell 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.
- Derived from this study: PubMed 27861833Bickell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina A Bickell, MD, MPH principal investigator
Icahn School of Medicine Mount Sinai
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tracking & Feedback in people with Breast Cancer, run by Icahn School of Medicine at Mount Sinai at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intervention effect of adjuvant treatment (time frame: at baseline and at one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01544374, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2016.