NCT03514433: TRIP

Translating Research Into Practice: Patient Navigation for Breast Cancer

Completed NA Results posted Last updated 3 July 2024

What this trial tests

NA trial testing TRIP Patient Navigation Intervention in Cancer, Breast in 1,725 participants. Completed in 22 September 2023.

Timeline

5 August 2016

Primary endpoint
22 September 2023

22 September 2023

Quick facts

Lead sponsor	Boston Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	1,725
Start date	5 August 2016
Primary completion	22 September 2023
Estimated completion	22 September 2023
Sites	5 locations across United States

Drugs / interventions tested

• TRIP Patient Navigation Intervention

Conditions studied

• Cancer, Breast — all drugs for Cancer, Breast →

Sponsor

Boston Medical Center

Who can join

18 and older, female only, with Cancer, Breast. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time-to-treatment Post-diagnosis Primary · 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.

Group	Value	95% CI
Control- Usual Care	44.78	± 39.54
TRIP Patient Navigation Intervention	45.40	± 33.98

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Patient Navigation in Cancer Treatment: A Systematic Review.
   Chen M, Wu VS, Falk D, Cheatham C, et al · · 2024 · cited 72× · PMID 38581470 · DOI 10.1007/s11912-024-01514-9
2. Patient navigator team perceptions on the implementation of a citywide breast cancer patient navigation protocol: a qualitative study.
   Loo S, Mullikin K, Robbins C, Xiao V, et al · · 2022 · cited 10× · PMID 35597947 · DOI 10.1186/s12913-022-08090-3
3. Assessment of patient navigation programs for breast cancer patients across the city of Boston.
   LeClair AM, Battaglia TA, Casanova NL, Haas JS, et al · · 2022 · cited 8× · PMID 34767089 · DOI 10.1007/s00520-021-06675-y
4. Using community-engaged methods to develop a study protocol for a cost analysis of a multi-site patient navigation intervention for breast cancer care.
   Rajabiun S, Xiao V, Bak S, Robbins C, et al · · 2022 · cited 3× · PMID 35804359 · DOI 10.1186/s12913-022-08192-y