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

Rectal Cancer Clinical Trial

Official title:

Community Dissemination of an Evidence-based CRC Screening Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01351220
• Other study ID #: RSGT CPPB-119384
• Status: Completed
• Phase: N/A
• First received: May 6, 2011
• Last updated: July 28, 2016
• Start date: July 2010
• Est. completion date: June 2015

Study information

• Verified date: February 2016
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: June 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Colon Cancer
• Rectal Cancer
• Rectal Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	UCLA Division of Cancer and Prevention Research	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Maxwell AE, Bastani R, Danao LL, Antonio C, Garcia GM, Crespi CM. Results of a community-based randomized trial to increase colorectal cancer screening among Filipino Americans. Am J Public Health. 2010 Nov;100(11):2228-34. doi: 10.2105/AJPH.2009.176230. Epub 2010 Sep 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in receipt of CRC screening at 6 months and 24 months	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	No