Translating Research Into Practice: Patient Navigation for Breast Cancer

Not Applicable

Completed

• Conditions: Cancer, Breast
• Interventions: Other: TRIP Patient Navigation Intervention

• Registration Number: NCT03514433
• Lead Sponsor: Boston Medical Center

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.

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 Clinical and Translational Science Award (CTSA) hubs (Boston University, Harvard University, Tufts University, and University of Massachusetts) partnered with the Boston Breast Cancer Equity Coalition, and the 5 hospitals that care for women with breast cancer.

Patient population: about 1,300 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. Five 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. Massachusetts General Hospital (site PI: Beverly Moy, MD)

5. Tufts Medical Center (PI: Karen Freund MD, MPH)

University of Massachusetts 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 Timeline

• Study Start: 2016-08-05
• Study First Submitted: 2018-04-21
• Study First Submitted QC: 2018-04-21
• Study First Posted: 2018-05-02
• Primary Completion: 2023-09-22
• Study Completion: 2023-09-22
• Results First Submitted: 2024-01-16
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-07
• Last Update Submitted: 2024-06-07
• Results First Posted: 2024-07-03
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1725

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TRIP Patient Navigation Intervention	TRIP Patient Navigation Intervention	This study will be enhancing current patient navigation at the participating 5 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.

Primary Outcome Measures

Name	Time	Method
Time-to-treatment Post-diagnosis	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.

Trial Locations

Locations (5)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States