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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01351220
First received: May 6, 2011
Last updated: May 9, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Colon Cancer
Rectal Cancer
Behavioral: Educational program and FOBT kits
Behavioral: Educational program and FOBT kits, and technical assistance
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Community Dissemination of an Evidence-based CRC Screening Intervention

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Change from Baseline in receipt of CRC screening at 6 months and 24 months [ Time Frame: baseline, 6-month and 24-month post intervention ] [ Designated as safety issue: No ]
    Subjects will receive any one of the 3 recommended CRC screening tests namely, Fecal Occult Blood Test, Flexible sigmoidoscopy or Colonoscopy


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1100
Study Start Date: July 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351220

Locations
United States, California
UCLA Division of Cancer and Prevention Research
Los Angeles, California, United States, 90095-6900
Sponsors and Collaborators
University of California, Los Angeles
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
  More Information

Publications:
Responsible Party: Annette Maxwell/Principal Investigator, UCLA Division of Cancer Prevention and Control Research
ClinicalTrials.gov Identifier: NCT01351220     History of Changes
Other Study ID Numbers: RSGT CPPB-119384
Study First Received: May 6, 2011
Last Updated: May 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
CRC screening
Prevention and early detection of CRC
Filipino
Dissemination

ClinicalTrials.gov processed this record on October 30, 2014