Community Dissemination of an Evidence-based Colorectal Cancer (CRC) Screening Intervention
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01351220|
Recruitment Status : Completed
First Posted : May 10, 2011
Last Update Posted : August 1, 2016
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|
|Colon Cancer Rectal Cancer||Behavioral: Educational program and FOBT kits Behavioral: Educational program and FOBT kits, and technical assistance||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Community Dissemination of an Evidence-based CRC Screening Intervention|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2015|
|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.
- 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
- 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 ]
- 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 ]
- 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 ]
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): NCT01351220
|United States, California|
|UCLA Division of Cancer and Prevention Research|
|Los Angeles, California, United States, 90095-6900|
|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|