- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03514433
Translating Research Into Practice (TRIP)
Translating Research Into Practice: A Regional Collaborative to Reduce Disparities in Breast Cancer Care
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This community-engaged program will demonstrate the feasibility of community-academic partnerships to provide innovations in information sharing and systems implementation targeted to reduce treatment disparities. Patient navigators will be able to utilize the patient database to track their patients throughout their treatment, and receive guidance regarding recommended social resources to patients experiencing hardships via the social determinants platform.
Who: The four Massachusetts CTSA hubs (Boston University, Harvard University, Tufts University, and University of Massachusetts) partnered with the Boston Breast Cancer Equity Coalition, and the 6 hospitals that care for women with breast cancer.
Patient population: about1,300 vulnerable inner city women with risk for delay in breast cancer care. Massachusetts (MA) Cancer Registry data identified the following characteristics of Boston residents with greatest delays in breast cancer treatment: Black, Hispanic, non-English speaking, and public health insurance. Six health care institutions care for >90% of these women:
- Beth Israel Deaconess Medical Center (site PI: Ted James, MD)
- Boston Medical Center (PI: Tracy Battaglia MD, MPH)
- Brigham Women's Hospital/Dana-Farber Cancer Institute (PI: Jennifer Haas MD, MPH)
- Faulkner Hospital (site PI: Rachel Freedman, MD)
- Massachusetts General Hospital (site PI: Beverly Moy, MD)
- Tufts Medical Center (PI: Karen Freund MD, MPH)
UMass Medical Center (PI: Stephenie Lemon, PhD) will play an integral role in the planning and implementation of the TRIP intervention but is not a clinical site.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, United States, 02111
- Tufts Medical Center
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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Boston, Massachusetts, United States, 02215
- Brigham and Women's Faulkner Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- are an adult female 18 years of age or older;
- reside within 25 miles of the City of Boston;
- have any of the following risk factors for delays in care: are Black and/or Hispanic ethnicity, do not speak English as their primary language, and/or have only public insurance or are uninsured at the time of diagnosis.
Exclusion Criteria:
- cancer diagnosis made > 60 days prior to enrollment, such that the ability of the intervention to effect the outcome is limited;
- presence of a cognitive impairment such as dementia or delirium from any cause (e.g. metabolic, medication or drug induced), given the unique challenges to their treatment decision making/ adherence and the fact that the intervention would not include the patient directly, but rather the family;
- home residence is outside of the city of Boston, Massachusetts.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Historical Control
This study will be utilizing electronic health record data to identify patients that match the TRIP eligibility criteria and received patient navigation prior to study rollout in June 2018.
These patients will receive standard patient navigation at their care site and will act as historical controls in comparison to the TRIP experimental group.
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Experimental: TRIP Patient Navigation Intervention
This study will be enhancing current patient navigation at the participating 6 hospitals with the 3 components of the TRIP intervention (a shared patient registry, a social determinants of health platform, and additional training and support for Patient Navigators).
All patients that are identified as TRIP eligible will receive these intervention benefits and will be categorized into the experimental arm of the study.
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The TRIP intervention will replace the current standard of care at the 6 participating hospitals once it is rolled out on-site.
Any TRIP eligible patients receiving patient navigation services over the course of the study will receive the enhanced services.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time-to-treatment post-diagnosis
Time Frame: Within 365 days of enrollment
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The receipt of care will be defined as initiation of care within 365 days.
This will be a continuous outcome defined as the number of days from definitive tissue biopsy (Time 0) to treatment initiation (Time 1).
Treatment initiation is defined as the date of first cancer treatment: surgical, radiation, or systemic therapy (including chemotherapy, immunotherapy, targeted therapy, hormonal therapy).
Time to treatment initiation can take any value from 0 days to 365 days (study period).
The clinical outcome will be derived from data in the patient's medical record.
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Within 365 days of enrollment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tracy Battaglia, MD., MPH, Boston Medical Center
Publications and helpful links
General Publications
- Rajabiun S, Xiao V, Bak S, Robbins C, Casanova N, Cabral HJ, Lemon SC, Haas JS, Freund KM, Battaglia T; TRIP Consortium. Using community-engaged methods to develop a study protocol for a cost analysis of a multi-site patient navigation intervention for breast cancer care. BMC Health Serv Res. 2022 Jul 8;22(1):881. doi: 10.1186/s12913-022-08192-y.
- Loo S, Mullikin K, Robbins C, Xiao V, Battaglia TA, Lemon SC, Gunn C; TRIP Consortium. Patient navigator team perceptions on the implementation of a citywide breast cancer patient navigation protocol: a qualitative study. BMC Health Serv Res. 2022 May 21;22(1):683. doi: 10.1186/s12913-022-08090-3.
- LeClair AM, Battaglia TA, Casanova NL, Haas JS, Freund KM, Moy B, Parsons SK, Ko NY, Ross J, Ohrenberger E, Mullikin KR, Lemon SC. Assessment of patient navigation programs for breast cancer patients across the city of Boston. Support Care Cancer. 2022 Mar;30(3):2435-2443. doi: 10.1007/s00520-021-06675-y. Epub 2021 Nov 12.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-37314
- 1U01TR002070-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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