U01 CRC Project for Vietnamese Americans

NCT03413605 | Completed Results

• 2 other identifiers: U01 Viet CRCU01MD010627
• Study Type: interventional
• Target: 801
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Colorectal Cancer Screening Rate

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

  12 months

Study Arms (2)

a multilevel CBPR intervention

EXPERIMENTAL

The intervention will be delivered in group-based education workshop format. The education session is a curriculum-based group education; each group will be having about 15-20 participants. We will allow 5-7 minutes for participants to get to know each other and to get comfortable talking to the group. Education will have two major topics.(a) CDC's standard Clinical Preventive Services Guidelines for adults 50+ (CPS). (b) culturally tailored CRC information discussion. This session is to increase knowledge, change cultural beliefs and attitudes on risks of CRC and benefits of screening by using interactive discussion approaches, visual aids, motivation video and print materials.

Behavioral: A Multilevel CBPR Intervention

control group

NO INTERVENTION

the standard CDC's Clinical Preventive Services Guidelines for adults 50+ (CPS) will be provided to control groups.

Interventions

A Multilevel CBPR Intervention BEHAVIORAL

The intervention will be implemented through a group-based education workshop. The education session is a curriculum-based group education; each group will be having about 15-20 participants. All group education sessions will take place at collaborating Viet community partners sites, and delivered in Vietnamese language, with offering of refreshment. We will allow 5-7 minutes for participants to get to know each other and to get comfortable talking to the group. Education will have two major topics--- (a) CDC's standard Clinical Preventive Services Guidelines for adults 50+ (CPS). (b) culturally tailored CRC information discussion.

a multilevel CBPR intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• self-identified Vietnamese ethnicity,
• age 50 and above,
• accessible by cell telephone,
• presence in the same geographic study area for a period of one year (to minimize participant attrition);
• not enrolled in any CRC intervention (to prevent a potential program impact),
• do not have the colorectal polyp, CRC cancer or a family history of CRC (first-degree relative),
• non-adherent to CRC screening guidelines (never had CRC screening or are overdue for screening).

You may not qualify if:

• enrolled in any CRC intervention (to prevent a potential program impact)
• have the colorectal polyp, CRC cancer or a family history of CRC
• had CRC screening or adherent to CRC screening guidelines

Sponsors & Collaborators

• Temple University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (2)

Vietnamese community center of Atlantic city

Atlantic City, New Jersey, 08401, United States

Location

Bo De Temple

Philadelphia, Pennsylvania, 19147, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Dr. Grace X. Ma
• Organization: Center for Asian Health, Lewis Katz School of Medicine, TempleUniversity

grace.ma@temple.edu

215-707-6493

Study Officials

• Grace X Ma, PhD

  Temple University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: January 29, 2018
• Study Start: June 1, 2016
• Primary Completion: April 28, 2021
• Study Completion: April 28, 2021
• Last Updated: August 14, 2023
• Results First Posted: August 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)