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

Sponsor
Jonsson Comprehensive Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT01351220
Collaborator
American Cancer Society, Inc. (Other)
1,100
1
2
59
18.6

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Behavioral: Educational program and FOBT kits
  • Behavioral: Educational program and FOBT kits, and technical assistance
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
1100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Screening
Official Title:
Community Dissemination of an Evidence-based CRC Screening Intervention
Study Start Date :
Jul 1, 2010
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline in receipt of CRC screening at 6 months and 24 months [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

Secondary Outcome Measures

  1. Change from Baseline in intention to obtain screening at 6 months and 24 months [baseline, 6-months and 24-months after exposure to the intervention]

  2. Change from Baseline in CRC screening knowledge at 6 months and 24 months [baseline, 6 months and 24 months after exposure to the educational program]

  3. Change from Baseline in frequency of patient provider communication at 6 months and 24 months [baseline, 6 and 24 months after exposure to the intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 UCLA Division of Cancer and Prevention Research Los Angeles California United States 90095-6900

Sponsors and Collaborators

  • Jonsson Comprehensive Cancer Center
  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01351220
Other Study ID Numbers:
  • RSGT CPPB-119384
First Posted:
May 10, 2011
Last Update Posted:
Aug 1, 2016
Last Verified:
Feb 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Jonsson Comprehensive Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 1, 2016