search
Back to results

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

Primary Purpose

Colon Cancer, Rectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational program and FOBT kits
Educational program and FOBT kits, and technical assistance
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colon Cancer focused on measuring CRC screening, Prevention and early detection of CRC, Filipino, Dissemination

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UCLA Division of Cancer and Prevention Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Basic dissemination

Organizational dissemination

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from Baseline in intention to obtain screening at 6 months and 24 months
Change from Baseline in CRC screening knowledge at 6 months and 24 months
Change from Baseline in frequency of patient provider communication at 6 months and 24 months

Full Information

First Posted
May 6, 2011
Last Updated
July 28, 2016
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
American Cancer Society, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01351220
Brief Title
Community Dissemination of an Evidence-based Colorectal Cancer (CRC) Screening Intervention
Official Title
Community Dissemination of an Evidence-based CRC Screening Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
American Cancer Society, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Rectal Cancer
Keywords
CRC screening, Prevention and early detection of CRC, Filipino, Dissemination

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Basic dissemination
Arm Type
Active Comparator
Arm Title
Organizational dissemination
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Educational program and FOBT kits
Intervention Description
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
Intervention Name(s)
Educational program and FOBT kits, and technical assistance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in receipt of CRC screening at 6 months and 24 months
Description
Subjects will receive any one of the 3 recommended CRC screening tests namely, Fecal Occult Blood Test, Flexible sigmoidoscopy or Colonoscopy
Time Frame
baseline, 6-month and 24-month post intervention
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annette E Maxwell, Dr.P.H.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leda L Danao, Ph.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Study Director
Facility Information:
Facility Name
UCLA Division of Cancer and Prevention Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-6900
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20864724
Citation
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.
Results Reference
background
PubMed Identifier
28948137
Citation
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.
Results Reference
derived
PubMed Identifier
27282431
Citation
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. Erratum In: Transl Behav Med. 2016 Dec;6(4):676-677.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs