Community Dissemination of an Evidence-based Colorectal Cancer (CRC) Screening Intervention

July 28, 2016 updated by: Jonsson Comprehensive Cancer Center

Community Dissemination of an Evidence-based CRC Screening Intervention

Filipino Americans have lower rates of colorectal cancer (CRC) screening, later stage of diagnosis and poorer survival relative to other racial/ethnic groups. To address this disparity, the investigators developed a multi-component intervention to increase CRC screening and have determined its efficacy in a randomized trial (Maxwell,et. al., 2010). This study aims to determine how an intervention to increase CRC screening can best be integrated within the cultural norms and existing structures of churches and community based organizations (CBOs) with predominantly Filipino American membership to ensure broad dissemination to those in need of screening.

The investigators will provide our partner CBOs with resources and technical assistance, including training of community volunteers as health advisors, to enable them to promote CRC screening to their constituents. Using a scientifically rigorous research design, the investigators will compare two dissemination strategies: Basic dissemination which consists of a single kick-off event during which community health advisors will receive print materials and FOBT kits for distribution and training on how to conduct educational small-group sessions; and Organizational dissemination aimed at integrating CRC screening dissemination into organizational practices and processes that can be sustained after the end of the study. The study will be implemented in 20 CBOs and will train 100 community health advisors (CHAs). The impact of the two dissemination strategies will be comprehensively assessed by collecting data at the CBO level, from the CHAs and from 1000 Filipino American participants. The investigators will compare the proportion of Filipino American participants who obtain CRC screening by dissemination strategy, but the investigators will also assess how many are reached, if the intervention is implemented as planned, how CBOs support the screening efforts at their regular activities, and if CBOs and CHAs maintain their efforts over the 4 years of the study.

The investigators hypothesize that CBOs can implement evidence-based strategies to promote CRC screening and CHAs in the organizational dissemination arm will reach more participants and more screened participants than CHAs in the basic dissemination arm; and organizations in the organizational dissemination arm will adopt more CRC screening activities and maintain these better than organizations in the basic dissemination arm.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095-6900
        • UCLA Division of Cancer and Prevention Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Filipino American
  • 50 to 75 years of age
  • Must not have been diagnosed with CRC
  • Must not be adherent to USPSTF CRC screening guidelines

Exclusion Criteria:

  • Not Filipino American
  • Younger than 50 or older than 75 years of age
  • Have been diagnosed with CRC
  • Adherent to USPSTF CRC screening guidelines

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Basic dissemination
Behavioral: Educational program and FOBT kits
Subjects will participate in a CRC small group educational program and receive FOBT kits from community health advisors who have received a one-time training session.
Active Comparator: Organizational dissemination
Behavioral: Educational program and FOBT kits, and technical assistance
In addition to subjects' receipt of a CRC small group educational program and FOBT kits, leadership training and technical support will be provided to the community health advisors and selected leaders and members of the organization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in receipt of CRC screening at 6 months and 24 months
Time Frame: baseline, 6-month and 24-month post intervention
Subjects will receive any one of the 3 recommended CRC screening tests namely, Fecal Occult Blood Test, Flexible sigmoidoscopy or Colonoscopy
baseline, 6-month and 24-month post intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in intention to obtain screening at 6 months and 24 months
Time Frame: baseline, 6-months and 24-months after exposure to the intervention
baseline, 6-months and 24-months after exposure to the intervention
Change from Baseline in CRC screening knowledge at 6 months and 24 months
Time Frame: baseline, 6 months and 24 months after exposure to the educational program
baseline, 6 months and 24 months after exposure to the educational program
Change from Baseline in frequency of patient provider communication at 6 months and 24 months
Time Frame: baseline, 6 and 24 months after exposure to the intervention
baseline, 6 and 24 months after exposure to the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

American Cancer Society, Inc.

Investigators

  • Principal Investigator: Annette E Maxwell, Dr.P.H., University of California, Los Angeles
  • Study Director: Leda L Danao, Ph.D., University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

May 6, 2011

First Submitted That Met QC Criteria

May 9, 2011

First Posted (Estimate)

May 10, 2011

Study Record Updates

Last Update Posted (Estimate)

August 1, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSGT CPPB-119384

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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