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U01 CRC Project for Vietnamese Americans

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
A Multilevel CBPR Intervention
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vietnamese community center of Atlantic city
  • Bo De Temple

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

a multilevel CBPR intervention

control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Colorectal Cancer Screening Rate
percentage of subjects, who received colorectal screening at 12-month Follow Up

Secondary Outcome Measures

Full Information

First Posted
December 11, 2017
Last Updated
July 20, 2023
Sponsor
Temple University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03413605
Brief Title
U01 CRC Project for Vietnamese Americans
Official Title
A Multilevel CBPR Intervention to Improve Colorectal Cancer Screening in Underserved Vietnamese Americans
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
April 28, 2021 (Actual)
Study Completion Date
April 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
801 (Actual)

8. Arms, Groups, and Interventions

Arm Title
a multilevel CBPR intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
the standard CDC's Clinical Preventive Services Guidelines for adults 50+ (CPS) will be provided to control groups.
Intervention Type
Behavioral
Intervention Name(s)
A Multilevel CBPR Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Colorectal Cancer Screening Rate
Description
percentage of subjects, who received colorectal screening at 12-month Follow Up
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace X Ma, PhD
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vietnamese community center of Atlantic city
City
Atlantic City
State/Province
New Jersey
ZIP/Postal Code
08401
Country
United States
Facility Name
Bo De Temple
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19147
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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U01 CRC Project for Vietnamese Americans

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