Translating Research Into Practice: Patient Navigation for Breast Cancer

NCT03514433 | Completed Results DMC

• 2 other identifiers: H-373141U01TR002070-01
• Study Type: interventional
• Target: 1,725
• Locations: 1 country
• Sites: 5

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.

Conditions

Cancer, Breast

Keywords

Patient Navigation; Disparity; Social Determinants

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control- Usual Care

NO INTERVENTION

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. These patients will receive standard patient navigation at their care site and will act as controls in comparison to the TRIP experimental group.

TRIP Patient Navigation Intervention

EXPERIMENTAL

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.

Other: TRIP Patient Navigation Intervention

Interventions

TRIP Patient Navigation Intervention OTHER

The TRIP intervention will replace the current standard of care at the 5 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.

TRIP Patient Navigation Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Medical Center: lead
• Boston University: collaborator
• University of Massachusetts, Worcester: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Tufts Medical Center: collaborator
• Dana-Farber Cancer Institute: collaborator
• Massachusetts General Hospital: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (5)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (3)

• 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.

  PMID: 35804359 DERIVED

• 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.

  PMID: 35597947 DERIVED

• 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.

  PMID: 34767089 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Generalizability was limited since participants were only enrolled within the Boston health systems with existing navigation. In addition, the COVID-19 pandemic caused care disruption.

Results Point of Contact

• Title: Tracy A Battaglia, MD, MPH
• Organization: Boston Medical Center

Tracy.Battaglia@bmc.org

617 638 7428

Study Officials

• Tracy Battaglia, MD., MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized cluster stepped wedge design will be conducted. This pragmatic design involves a sequential, randomized roll-out of the intervention across 5 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 five 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.

Study Record Dates

• First Submitted: April 21, 2018
• First Posted: May 2, 2018
• Study Start: August 5, 2016
• Primary Completion: September 22, 2023
• Study Completion: September 22, 2023
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)