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Trial record 14 of 45 for:    colon cancer | ( Map: Hawaii, United States )

Lay Health Worker Outreach in Increasing Colorectal Cancer Screening in Asian Americans

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ClinicalTrials.gov Identifier: NCT03115372
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : May 9, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
This randomized clinical trial studies how well a lay health worker outreach works in increasing colorectal cancer screening in Asian Americans. Training community members to educate participants about colorectal cancer and its prevention may improve colorectal cancer screening rates in Asian Americans.

Condition or disease Intervention/treatment Phase
Colorectal Carcinoma Health Status Unknown Healthy Subject Other: Educational Intervention Other: Informational Intervention Other: Survey Administration Behavioral: Telephone-Based Intervention Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. Evaluate the efficacy of lay health worker (LHW) outreach on colorectal cancer (CRC) screening among 3 Asian American groups (Filipinos, Hmong, and Koreans) in a cluster randomized controlled trial (RCT) comparing CRC education delivered by LHWs (intervention) to a CRC brochure and nutrition education (control).

II. Examine the processes through which LHWs communicate with, connect to, and convince community members from 3 Asian American cultures of the importance of CRC screening using mixed methods.

OUTLINE: Lay health workers (LHWs) are randomized to 1 of 2 groups.

GROUP I (CRC EDUCATION): LHWs undergo training over 3 days and recruit 15 participants from their social network. Participants attend a CRC educational session conducted by an LWH over 90 minutes at month 1 and 3. Participants receive phone calls from the LWH at months 2 and 4 reminding them about CRC screening.

GROUP II (CRC BROCHURE): LHWs undergo training over 3 days and recruit 15 participants from their social network. Participants attend a lecture on healthy nutrition for cardiovascular health presented by a professional health educator at months 1 and 3. After the first meeting, participants receive a brochure on CRC screening. Participants receive phone calls from the LWH at months 2 and 4 regarding changes in their nutritional behavior. Participants may attend an optional post-intervention LHW outreach session on CRC screening.

After completion of the study, patients are followed up at 2 months.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 982 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: AANCART: The National Center for Reducing Asian American Cancer Health Disparities Research Project on Lay Health Workers and Asian Americans
Actual Study Start Date : February 2012
Actual Primary Completion Date : July 1, 2015
Actual Study Completion Date : September 1, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group I (CRC education)
LWHs undergo training over 3 days and recruit 15 participants from their social network. Participants attend a CRC educational session conducted by an LWH over 90 minutes at month 1 and 3. Participants receive phone calls from the LWH at months 2 and 4 reminding them about CRC screening.
Other: Educational Intervention
Attend CRC education session
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Other: Survey Administration
Ancillary studies

Behavioral: Telephone-Based Intervention
Receive telephone reminder about CRC screening

Active Comparator: Group II (CRC brochure)
LHWs undergo training over 3 days and recruit 15 participants from their social network. Participants attend a lecture on healthy nutrition for cardiovascular health presented by a professional health educator at months 1 and 3. After the first meeting, participants receive a brochure on CRC screening. Participants receive phone calls from the LWH at months 2 and 4 regarding changes in their nutritional behavior. Participants may attend an optional post-intervention LHW outreach session on CRC screening.
Other: Educational Intervention
Attend healthy nutrition session
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Other: Informational Intervention
Receive CRC screening brochure

Other: Survey Administration
Ancillary studies

Behavioral: Telephone-Based Intervention
Receive telephone reminder about healthy nutrition




Primary Outcome Measures :
  1. Proportion of participants who report ever having had a CRC screening test [ Time Frame: Baseline to 6 months ]
    Bivariable and multivariable analyses of the binary outcomes (CRC screening ever, up-to-date, and intention) will be conducted using generalized linear models to evaluate the efficacy of the intervention. A linear model with identity link function will be used with group (intervention or control), time (pre- or post-), and group-by-time interaction to test for a difference in the change from pre- to post-intervention between the 2 groups, thus measuring the efficacy of the intervention.


Secondary Outcome Measures :
  1. Proportion of participants who are up-to-date for CRC screening [ Time Frame: At 6 months ]
    Bivariable and multivariable analyses of the binary outcomes (CRC screening ever, up-to-date, and intention) will be conducted using generalized linear models to evaluate the efficacy of the intervention.

  2. Proportion of participants who intend to obtain CRC screening in the next 6 months [ Time Frame: At 6 months ]
    Bivariable and multivariable analyses of the binary outcomes (CRC screening ever, up-to-date, and intention) will be conducted using generalized linear models to evaluate the efficacy of the intervention.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • LHW: self-identified as Filipino, Hmong, or Korean Americans
  • LHW: age 18 or older
  • LHW: are fluent in a Filipino language (Tagalog or Ilocano), Hmong, Korean, or English
  • LHW: Live in the relevant area and intend to stay there for the next 12 months
  • PARTICIPANTS: Self-identified as Filipino, Hmong, or Korean Americans
  • PARTICIPANTS: speak a language that the LHW can speak such as Tagalog, Ilocano, Hmong, Korean, or English
  • PARTICIPANTS: live in relevant area and intend to stay there for at least 12 months
  • PARTICIPANTS: Are willing to participate in a study about health behaviors involving nutrition or CRC screening

Exclusion Criteria:

  • Personal history of CRC
  • Medical problems which may prevent them from attending 2 educational sessions

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): NCT03115372


Locations
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United States, California
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
UCSF Medical Center-Mount Zion
San Francisco, California, United States, 94115
United States, Hawaii
University of Hawaii Cancer Center
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Tung Nguyen UCSF Medical Center-Mount Zion

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03115372     History of Changes
Other Study ID Numbers: 11056
NCI-2017-00515 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
11056 ( Other Identifier: UCSF Medical Center )
P30CA082103 ( U.S. NIH Grant/Contract )
U54CA153499 ( U.S. NIH Grant/Contract )
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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