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Translating Research Into Practice (TRIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03514433
Recruitment Status : Completed
First Posted : May 2, 2018
Last Update Posted : September 28, 2023
Sponsor:
Collaborators:
Boston University
University of Massachusetts, Worcester
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Tufts Medical Center
Dana-Farber Cancer Institute
Massachusetts General Hospital
National Center for Advancing Translational Sciences (NCATS)
Information provided by (Responsible Party):
Boston Medical Center

Study Description
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Brief Summary:
The TRIP Project aims to overcome barriers to widespread implementation and dissemination of evidence-based practices that will improve the delivery of guideline-concordant care to vulnerable women with breast cancer. To accomplish this goal the study team will create (a) regional patient registries; (b) systematic screening for social barriers to care with a personalized referral plan; and (c) patient navigation services that integrate into one model of care to improve the quality and effectiveness of care delivery, for minority and/or low-income women with breast cancer in Boston.

Condition or disease Intervention/treatment Phase
Cancer, Breast Other: TRIP Patient Navigation Intervention Not Applicable

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:

  1. Beth Israel Deaconess Medical Center (site PI: Ted James, MD)
  2. Boston Medical Center (PI: Tracy Battaglia MD, MPH)
  3. Brigham Women's Hospital/Dana-Farber Cancer Institute (PI: Jennifer Haas MD, MPH)
  4. Faulkner Hospital (site PI: Rachel Freedman, MD)
  5. Massachusetts General Hospital (site PI: Beverly Moy, MD)
  6. 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1732 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized cluster stepped wedge design will be conducted. This pragmatic design involves a sequential, randomized roll-out of the intervention across 6 participating clinical sites or "clusters" over 3 month intervals or "steps". Consistent with a stepped wedge design with one cluster per step, prior to the collection of data in the pre-intervention period, the investigators will generate a set of uniform random numbers for each of the six clusters to assign a starting period for the study intervention. There will be no crossover of patients from usual care to the intervention. That is, patients at each site during the pre-intervention period will experience only usual care and will act as historical controls and those enrolled after the initiation of intervention will experience the intervention.
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Translating Research Into Practice: A Regional Collaborative to Reduce Disparities in Breast Cancer Care
Actual Study Start Date : August 6, 2018
Actual Primary Completion Date : September 22, 2023
Actual Study Completion Date : September 22, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
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.
 Other: TRIP Patient Navigation Intervention
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.


Outcome Measures
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Primary Outcome Measures :
  1. Time-to-treatment post-diagnosis [ Time Frame: Within 365 days of enrollment ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   All women with breast cancer diagnosed at a participating study site during the study period will be eligible for inclusion if they meet three study criteria
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. are an adult female 18 years of age or older;
  2. reside within 25 miles of the City of Boston;
  3. 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:

  1. cancer diagnosis made > 60 days prior to enrollment, such that the ability of the intervention to effect the outcome is limited;
  2. 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;
  3. home residence is outside of the city of Boston, Massachusetts.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514433


Locations
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United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Boston Medical Center
Boston, Massachusetts, United States, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Boston Medical Center
Boston University
University of Massachusetts, Worcester
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Tufts Medical Center
Dana-Farber Cancer Institute
Massachusetts General Hospital
National Center for Advancing Translational Sciences (NCATS)
Investigators
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Principal Investigator: Tracy Battaglia, MD., MPH Boston Medical Center
  Study Documents (Full-Text)

Documents provided by Boston Medical Center:
Informed Consent Form  [PDF] November 21, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT03514433    
Other Study ID Numbers: H-37314
1U01TR002070-01 ( U.S. NIH Grant/Contract )
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: September 28, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston Medical Center:
Patient Navigation
Disparity
Social Determinants
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases