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U01 CRC Project for Vietnamese Americans

A Multilevel CBPR Intervention to Improve Colorectal Cancer Screening in Underserved Vietnamese Americans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03413605
Enrollment
801
Registered
2018-01-29
Start date
2016-06-01
Completion date
2021-04-28
Last updated
2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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.

Interventions

BEHAVIORALA 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.

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
Temple University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Colorectal Cancer Screening Rate12 monthspercentage of subjects, who received colorectal screening at 12-month Follow Up

Countries

United States

Participant flow

Participants by arm

ArmCount
a Multilevel CBPR Intervention
The intervention was delivered in group-based education workshop format. The education session was a curriculum-based group education; each group had about 15-20 participants. We allowed 5-7 minutes for participants to get to know each other and to get comfortable talking to the group. Education had two major topics.(a) CDC's standard Clinical Preventive Services Guidelines for adults 50+ (CPS). (b) culturally tailored CRC information discussion. This session was aimed 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.
392
Control Group
the standard CDC's Clinical Preventive Services Guidelines for adults 50+ (CPS) was provided to control groups.
409
Total801

Baseline characteristics

Characteristica Multilevel CBPR InterventionControl GroupTotal
Age, Customized
50-74 years old
325 Participants321 Participants646 Participants
Age, Customized
75 or older
67 Participants88 Participants155 Participants
Nativity Status
Foreign Born
384 Participants399 Participants783 Participants
Nativity Status
US Born
2 Participants3 Participants5 Participants
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
222 Participants252 Participants474 Participants
Sex: Female, Male
Male
170 Participants157 Participants327 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 3920 / 409
other
Total, other adverse events
0 / 3920 / 409
serious
Total, serious adverse events
0 / 3920 / 409

Outcome results

Primary

Colorectal Cancer Screening Rate

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

Time frame: 12 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
a Multilevel CBPR InterventionColorectal Cancer Screening Rate333 Participants
Control GroupColorectal Cancer Screening Rate162 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026