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

NCT ID: NCT01351220

Last Updated: 2016-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colon Cancer Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Basic dissemination

Group Type ACTIVE_COMPARATOR

Educational program and FOBT kits

Intervention Type BEHAVIORAL

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.

Organizational dissemination

Group Type ACTIVE_COMPARATOR

Educational program and FOBT kits, and technical assistance

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Annette E Maxwell, Dr.P.H.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Leda L Danao, Ph.D.

Role: STUDY_DIRECTOR

University of California, Los Angeles

Locations

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UCLA Division of Cancer and Prevention Research

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20864724 (View on PubMed)

Maxwell AE, Crespi CM, Arce AA, Bastani R. Exploring the effects of longstanding academic-community partnerships on study outcomes: A case study. Prev Med Rep. 2017 Sep 12;8:101-107. doi: 10.1016/j.pmedr.2017.09.003. eCollection 2017 Dec.

Reference Type DERIVED
PMID: 28948137 (View on PubMed)

Maxwell AE, Danao LL, Cayetano RT, Crespi CM, Bastani R. Implementation of an evidence-based intervention to promote colorectal cancer screening in community organizations: a cluster randomized trial. Transl Behav Med. 2016 Jun;6(2):295-305. doi: 10.1007/s13142-015-0349-5.

Reference Type DERIVED
PMID: 27282431 (View on PubMed)

Other Identifiers

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RSGT CPPB-119384

Identifier Type: -

Identifier Source: org_study_id

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