NCT01351220

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 10, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

August 1, 2016

Status Verified

February 1, 2016

Enrollment Period

3.9 years

First QC Date

May 6, 2011

Last Update Submit

July 28, 2016

Conditions

Colon CancerRectal Cancer

Keywords

CRC screeningPrevention and early detection of CRCFilipinoDissemination

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Basic dissemination

ACTIVE COMPARATOR
Behavioral: Educational program and FOBT kits

Organizational dissemination

ACTIVE COMPARATOR
Behavioral: Educational program and FOBT kits, and technical assistance

Interventions

Educational program and FOBT kitsBEHAVIORAL

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.

Basic dissemination
Educational program and FOBT kits, and technical assistanceBEHAVIORAL

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.

Organizational dissemination

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Filipino American
  • to 75 years of age
  • Must not have been diagnosed with CRC
  • Must not be adherent to USPSTF CRC screening guidelines

You may not qualify if:

  • Not Filipino American
  • Younger than 50 or older than 75 years of age
  • Have been diagnosed with CRC
  • Adherent to USPSTF CRC screening guidelines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Division of Cancer and Prevention Research

Los Angeles, California, 90095-6900, United States

Location

Related Publications (3)

  • 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.

    PMID: 20864724BACKGROUND

  • 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.

    PMID: 28948137DERIVED

  • 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.

    PMID: 27282431DERIVED

MeSH Terms

Conditions

Colonic NeoplasmsRectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Annette E Maxwell, Dr.P.H.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

  • Leda L Danao, Ph.D.

    University of California, Los Angeles

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2011

First Posted

May 10, 2011

Study Start

July 1, 2010

Primary Completion

June 1, 2014

Study Completion

June 1, 2015

Last Updated

August 1, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)