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Trial record 8 of 179 for:    colon cancer | ( Map: New Jersey, United States )

U01 CRC Project for Vietnamese Americans

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ClinicalTrials.gov Identifier: NCT03413605
Recruitment Status : Recruiting
First Posted : January 29, 2018
Last Update Posted : December 13, 2018
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Temple University

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
Colorectal Cancer Behavioral: A Multilevel CBPR Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 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 : June 1, 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Colorectal Cancer Screening Rate [ Time Frame: 12 months ]
    percentage of subjects, who received colorectal screening at 12-month Follow Up



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03413605


Contacts
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Contact: Grace X Ma, PhD 215-707-6493 grace.ma@temple.edu

Locations
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United States, New Jersey
Vietnamese community center of Atlantic city Recruiting
Atlantic City, New Jersey, United States, 08401
Contact: Nga Vu    215-552-2155    ngavu@vietlead.org   
United States, Pennsylvania
Bo De Temple Recruiting
Philadelphia, Pennsylvania, United States, 19147
Contact: Tam Tran    917-952-6396    tranquanniem@yahoo.com   
Sponsors and Collaborators
Temple University
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Grace X Ma, PhD Temple University

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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT03413605     History of Changes
Other Study ID Numbers: U01 Viet CRC
U01MD010627 ( U.S. NIH Grant/Contract )
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases