Translating Research Into Practice

Cancer, Breast Clinical Trial

— TRIP  

Official title:

Translating Research Into Practice: A Regional Collaborative to Reduce Disparities in Breast Cancer Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03514433
• Other study ID #: H-37314
• Secondary ID: 1U01TR002070-01
• Status: Completed
• Phase: N/A
• Start date: August 6, 2018
• Est. completion date: September 22, 2023

Study information

• Verified date: September 2023
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1732
• Est. completion date: September 22, 2023
• Est. primary completion date: September 22, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer, Breast

Intervention

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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Boston Medical Center	Boston	Massachusetts
United States	Brigham and Women's Faulkner Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (9)

Lead Sponsor	Collaborator
Boston Medical Center	Beth Israel Deaconess Medical Center, Boston University, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital, National Center for Advancing Translational Sciences (NCATS), Tufts Medical Center, University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-to-treatment post-diagnosis	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.	Within 365 days of enrollment