NCT03413605

U01 CRC Project for Vietnamese Americans

Completed NA Results posted Last updated 14 August 2023

What this trial tests

NA trial testing A Multilevel CBPR Intervention in Colorectal Cancer in 801 participants. Completed in 28 April 2021.

Timeline

1 June 2016

Primary endpoint
28 April 2021

28 April 2021

Quick facts

Lead sponsor	Temple University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	801
Start date	1 June 2016
Primary completion	28 April 2021
Estimated completion	28 April 2021
Sites	2 locations across United States

Drugs / interventions tested

• A Multilevel CBPR Intervention

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

Temple University

Who can join

50 and older, any sex, with Colorectal Cancer. 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.

Colorectal Cancer Screening Rate Primary · 12 months

percentage of subjects, who received colorectal screening at 12-month Follow Up

Group	Value	95% CI
a Multilevel CBPR Intervention	333
Control Group	162

Sponsor's own description

Colorectal cancer (CRC) is the second most commonly diagnosed cancer and the third highest cause of mortality in Vietnamese and Asian Americans. CRC incidence is rising rapidly in Vietnamese Americans, but they have among the lowest rates of CRC screening (14%) and are more likely to be diagnosed with advanced stage disease, which is highly preventable. Over 85% of Vietnamese Americans in our region (PA, NJ and NYC) are foreign-born with limited English proficiency, have low SES, and live in economically disadvantaged neighborhoods. Many lack knowledge about CRC risks and screening benefits and have limited access to culturally appropriate preventive care. Center for Asian Health, Temple University will be working with Vietnamese CBOs to address their critical health disparities. The investigators will test the hypothesis that the proposed multilevel CRC intervention will yield higher CRC screening rates compared to the control at 12-month follow-up. This project represents the first large-scale community-based randomized controlled trial of a multilevel, culturally-appropriate intervention to increase CRC screening among underserved Vietnamese. If effective, this innovative CRC intervention can be used as a model program that has potential impact, generalizability and sustainability in Asian American and other underserved ethnic communities.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Examining multilevel neighborhood socioeconomic characteristics associated with colorectal cancer screening in Vietnamese Americans residing in Philadelphia County.
   Bhimla A, Zhu L, Twardus S, Lin T, et al · · 2022 · cited 5× · PMID 35298654 · DOI 10.1093/tbm/ibab136