Colon CancerNCT01351220
Community Dissemination of an Evidence-based Colorectal Cancer (CRC) Screening Intervention
A study testing Educational program and FOBT kits and Educational program and FOBT kits, and technical assistance in people with Colon Cancer and Rectal Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer, Rectal Cancer
- What is being tested?
- Educational program and FOBT kits and Educational program and FOBT kits, and technical assistance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Filipino American
- 50 to 75 years of age
- Must not have been diagnosed with CRC
- Must not be adherent to USPSTF CRC screening guidelines
Who cannot join
- Not Filipino American
- Younger than 50 or older than 75 years of age
- Have been diagnosed with CRC
- Adherent to USPSTF CRC screening guidelines
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Division of Cancer and Prevention Research
Los Angeles, California, 90095-6900
About this study
Official title: Community Dissemination of an Evidence-based CRC Screening Intervention
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.
- Conditions
- Colon Cancer, Rectal Cancer
- Being tested
- Educational program and FOBT kits, Educational program and FOBT kits, and technical assistance
- Keywords
- CRC screening, Prevention and early detection of CRC, Filipino, Dissemination
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational program and FOBT kitsBehavioural
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 assistanceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Basic dissemination | Active comparator | Not described Receives: Behavioral: Educational program and FOBT kits |
| Organizational dissemination | Active comparator | Not described Receives: Behavioral: Educational program and FOBT kits, and technical assistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: baseline, 6-months and 24-months after exposure to the intervention
Change from Baseline in CRC screening knowledge at 6 months and 24 months
Measured: 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
Measured: baseline, 6 and 24 months after exposure to the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startJul 2010
- Primary completionJun 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Annette E Maxwell, Dr.P.H., Principal investigator, University of California, Los AngelesLeda L Danao, Ph.D., Study director, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351220
- Sponsor's protocol ID
- RSGT CPPB-119384
- Status last verified
- Feb 2016
- First submitted
- 6 May 2011
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 20864724Maxwell 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.
PubMed 28948137Maxwell 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.
PubMed 27282431
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Dissemination of an Evidence-based CRC Screening Intervention
- ClinicalTrials.gov ID
- NCT01351220
- Acronym / sponsor ID
- RSGT CPPB-119384
- Conditions
- Colon Cancer, Rectal Cancer
- Keywords
- CRC screening, Prevention and early detection of CRC, Filipino, Dissemination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Jul 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Basic dissemination | Active comparator | Behavioral: Educational program and FOBT kits |
| Organizational dissemination | Active comparator | Behavioral: Educational program and FOBT kits, and technical assistance |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Filipino American
- 50 to 75 years of age
- Must not have been diagnosed with CRC
- Must not be adherent to USPSTF CRC screening guidelines
Key exclusion criteria (4 listed)
- Not Filipino American
- Younger than 50 or older than 75 years of age
- Have been diagnosed with CRC
- Adherent to USPSTF CRC screening guidelines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational program and FOBT kitsSubjects 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. | Behavioural | Basic dissemination |
| Educational program and FOBT kits, and technical assistanceIn 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. | Behavioural | Organizational dissemination |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2016.
- Background: PubMed 20864724Maxwell 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.
- Derived from this study: PubMed 28948137Maxwell 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.
- Derived from this study: PubMed 27282431Maxwell 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annette E Maxwell, Dr.P.H. principal investigator
University of California, Los Angeles
Leda L Danao, Ph.D. study director
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational program and FOBT kits and Educational program and FOBT kits, and technical assistance in people with Colon Cancer and Rectal Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in receipt of CRC screening at 6 months and 24 months (time frame: baseline, 6-month and 24-month post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01351220, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2016.