U01 CRC Project for Vietnamese Americans

Sponsor
Temple University (Other)
Overall Status
Completed
CT.gov ID
NCT03413605
Collaborator
National Institute on Minority Health and Health Disparities (NIMHD) (NIH)
801
2
2
58.9
400.5
6.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: A Multilevel CBPR Intervention
N/A

Detailed 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. Thus, a multilevel intervention is needed to address the multiple barriers to and determinants of CRC screening in this community. Vietnamese community organizations (VCOs) serve dynamic social functions and represent an important resource for addressing this critical health disparity priority by promoting CRC screening. This project builds on established partnerships and successful work of Center for Asian Health, Temple University with Vietnamese CBOs that address their overwhelming health disparities. CBPR principles will be applied to engage 20 VCOs in all phases of planning, implementing, evaluating, and disseminating a culturally appropriate, theory- and evidence-based multilevel CRC intervention. The proposed intervention will be guided by Social Ecological Model, which addresses sociocultural, behavioral and environmental determinants and intervention strategies at the individual, interpersonal, and community organizational levels. CDC's Clinical Preventive Services Guidelines for adults 50+ (CPS) recommend that cancer screenings and other preventive services should be promoted. The standard CPS will be provided to both intervention and control groups, and intervention group will receive CPS + multilevel CRC intervention. Specific Aim 1 is to test the hypothesis that CPS + multilevel CRC intervention will yield higher CRC screening rates compared to CPS control at 12-month follow up; Aim 2 is to examine whether CPS + multilevel CRC intervention (which includes CHW-led group education, automated and interactive text messaging and phone-based peer support) is more effective in changing screening determinants (e.g. KAB, self-efficacy, risk factors, lifestyles, social support, social norms, access barriers) than CPS control condition; and Aim 3 is to assess costs and cost-effectiveness of CPS + multilevel CRC intervention compared to CPS control condition in relation to CRC screening rates in order to inform future dissemination efforts. In sum, this project represents the first large-scale community-based randomized controlled trial of a multilevel, culturally-appropriate CBPR intervention to increase CRC screening among underserved Vietnamese. If effective, this innovative multilevel CRC intervention can be used as a model program that has potential generalizability and sustainability in Asian American and other underserved ethnic communities to impact preventive behaviors at the population level.

Study Design

Study Type:
Interventional
Actual Enrollment :
801 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Multilevel CBPR Intervention to Improve Colorectal Cancer Screening in Underserved Vietnamese Americans
Actual Study Start Date :
Jun 1, 2016
Actual Primary Completion Date :
Apr 28, 2021
Actual Study Completion Date :
Apr 28, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: a multilevel CBPR intervention

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
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.

No Intervention: control group

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

Outcome Measures

Primary Outcome Measures

  1. Colorectal Cancer Screening Rate [12 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. self-identified Vietnamese ethnicity,

  2. age 50 and above,

  3. accessible by cell telephone,

  4. presence in the same geographic study area for a period of one year (to minimize participant attrition);

  5. not enrolled in any CRC intervention (to prevent a potential program impact),

  6. do not have the colorectal polyp, CRC cancer or a family history of CRC (first-degree relative),

  7. non-adherent to CRC screening guidelines (never had CRC screening or are overdue for screening).

Exclusion Criteria:
  1. enrolled in any CRC intervention (to prevent a potential program impact)

  2. have the colorectal polyp, CRC cancer or a family history of CRC

  3. had CRC screening or adherent to CRC screening guidelines

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vietnamese community center of Atlantic city Atlantic City New Jersey United States 08401
2 Bo De Temple Philadelphia Pennsylvania United States 19147

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Grace X Ma, PhD, Temple University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Temple University
ClinicalTrials.gov Identifier:
NCT03413605
Other Study ID Numbers:
  • U01 Viet CRC
  • U01MD010627
First Posted:
Jan 29, 2018
Last Update Posted:
May 12, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 12, 2021