Colorectal CancerNCT00137592
Promoting Colorectal Cancer Screening in Rural Colorado
A study testing small media, group education (multicomponent) in people with Colorectal Cancer, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
This community based participatory research study involves multicomponent educational interventions. Telephone interviews and focus groups of persons who are residents of the High Plains region of Colorado will be conducted. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- small media, group education (multicomponent)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Dec 2008
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Colorectal cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Health Sciences Center
Denver, Colorado, 80045-0508
About this study
This community based participatory research study involves multicomponent educational interventions. Telephone interviews and focus groups of persons who are residents of the High Plains region of Colorado will be conducted. A card study will also be carried out to collect limited data about colorectal cancer screening in primary care practices. The multicomponent intervention approaches (e.g., small media and group education) consist of educational materials about routine colorectal cancer screening.
Read the detailed description
Specific Aims:
- Using community-based participatory research (CBPR), incorporate an existing Community Advisory Council into a project-specific Joint Planning Committee to provide community voices and be experts for a project to design strategies to improve CRC screening of all adults over the age of 50 in the High Plains community.
- Work with the Joint Planning Committee to develop an acceptable and respectful message and dissemination plan to change the community perception concerning colorectal cancer screening.
- Conduct a random digit dialing survey of rural eastern Colorado to determine rates of individuals up to date on CRC screening and to determine current knowledge level of individuals over 50 concerning the need for CRC screening.
- Deliver the screening message(s) through the methods suggested by the Joint Planning Committee in two High Plains communities and solicit community members' reactions to the message(s) and dissemination approaches.
Setting
The Intervention Communities:
The nine rural counties within northeast Colorado that make up the High Plains communities encompass 15,000-square-miles. The economy is largely agricultural, with a population of approximately 90,000. Based on the 2000 census 22% (range 20-29%) of the population is over 50, which is higher than the state as a whole (20%) or the Denver Metropolitan Statistical Area - MSA (18%). There is not a single MSA in the High Plains region and most of the region is a frontier area and therefore considered an underserved community.
The Control Communities:
We will also utilize the 8 county region in southeastern Colorado as our control communities for the intervention evaluation.
Primary Care Offices:
This study will be conducted within the community detailed above. The intervention will be at the population level. Evaluation of the intervention will include surveys of providers and patients within the primary care offices in the High Plains Region (these offices are part of the High Plains Research Network [HPRN]) and piloting the intervention will occur in the primary care practices that are part of the Colorado Research Network (CaReNet). Both CaReNet and HPRN are practice based research networks (PBRNs) affiliated with the Department of Family Medicine at the University of Colorado.
Project Aims (Overview):
We will combine three different proven research approaches to develop and study a community-based intervention to improve CRC screening rates.
- Component 1: Intervention Planning:
- Using a community-based participatory research model, the Joint Planning Committee (JPC) composed of members of an established Community Advisory Council for a practice-based research network and other community members, we will explore and define the messages and the delivery approaches the community members feel are most likely to result in actual behavioral change.
- Component 2: Assessment of Intervention Effectiveness:
- Using a random digit dialing telephone survey, pre and post provider/patient card study and a provider survey, we will assess the impact of the intervention.
- Component 3: Evaluation of Intervention Process and Implementation:
- Using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework12, we will guide our evaluation of both the community-based participatory research process and the effects of the intervention developed.
- Conditions
- Colorectal Cancer
- Being tested
- small media, group education (multicomponent)
- Keywords
- screening, community health education
- Medical subject headings
- Colorectal Neoplasms, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
small media, group education (multicomponent)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: small media, group education (multicomponent) Receives: Behavioral: small media, group education (multicomponent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
colorectal cancer screening
Measured: 30 days
Secondary outcomes (1)
colorectal cancer screening knowledge
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startOct 2005
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- University of Colorado, Denver
- Responsible party
- Sponsor
- Investigators
- John M. Westfall, MD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137592
- Sponsor's protocol ID
- CDC-NCCDPHP-4547
- Other IDs
- PRC SIP 20-04
- Status last verified
- Sep 2012
- First submitted
- 26 Aug 2005
- Last updated
- 7 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Colorectal Cancer Screening in Rural Colorado
- ClinicalTrials.gov ID
- NCT00137592
- Acronym / sponsor ID
- CDC-NCCDPHP-4547
- Conditions
- Colorectal Cancer
- Keywords
- screening, community health education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- University of Colorado, Denver
- Study start
- Oct 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 30 Aug 2005 (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.
This community based participatory research study involves multicomponent educational interventions. Telephone interviews and focus groups of persons who are residents of the High Plains region of Colorado will be conducted. A card study will also be carried out to collect limited data about colorectal cancer screening in primary care practices. The multicomponent intervention approaches (e.g., small media and group education) consist of educational materials about routine colorectal cancer screening.
Detailed description
Specific Aims:
- Using community-based participatory research (CBPR), incorporate an existing Community Advisory Council into a project-specific Joint Planning Committee to provide community voices and be experts for a project to design strategies to improve CRC screening of all adults over the age of 50 in the High Plains community.
- Work with the Joint Planning Committee to develop an acceptable and respectful message and dissemination plan to change the community perception concerning colorectal cancer screening.
- Conduct a random digit dialing survey of rural eastern Colorado to determine rates of individuals up to date on CRC screening and to determine current knowledge level of individuals over 50 concerning the need for CRC screening.
- Deliver the screening message(s) through the methods suggested by the Joint Planning Committee in two High Plains communities and solicit community members' reactions to the message(s) and dissemination approaches.
Setting
The Intervention Communities:
The nine rural counties within northeast Colorado that make up the High Plains communities encompass 15,000-square-miles. The economy is largely agricultural, with a population of approximately 90,000. Based on the 2000 census 22% (range 20-29%) of the population is over 50, which is higher than the state as a whole (20%) or the Denver Metropolitan Statistical Area - MSA (18%). There is not a single MSA in the High Plains region and most of the region is a frontier area and therefore considered an underserved community.
The Control Communities:
We will also utilize the 8 county region in southeastern Colorado as our control communities for the intervention evaluation.
Primary Care Offices:
This study will be conducted within the community detailed above. The intervention will be at the population level. Evaluation of the intervention will include surveys of providers and patients within the primary care offices in the High Plains Region (these offices are part of the High Plains Research Network [HPRN]) and piloting the intervention will occur in the primary care practices that are part of the Colorado Research Network (CaReNet). Both CaReNet and HPRN are practice based research networks (PBRNs) affiliated with the Department of Family Medicine at the University of Colorado.
Project Aims (Overview):
We will combine three different proven research approaches to develop and study a community-based intervention to improve CRC screening rates.
- Component 1: Intervention Planning:
- Using a community-based participatory research model, the Joint Planning Committee (JPC) composed of members of an established Community Advisory Council for a practice-based research network and other community members, we will explore and define the messages and the delivery approaches the community members feel are most likely to result in actual behavioral change.
- Component 2: Assessment of Intervention Effectiveness:
- Using a random digit dialing telephone survey, pre and post provider/patient card study and a provider survey, we will assess the impact of the intervention.
- Component 3: Evaluation of Intervention Process and Implementation:
- Using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework12, we will guide our evaluation of both the community-based participatory research process and the effects of the intervention developed.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: small media, group education (multicomponent)Behavioral: small media, group education (multicomponent) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Colorectal cancer
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 |
|---|---|---|
| small media, group education (multicomponent) | Behavioural | Lifestyle counseling |
Primary outcome
colorectal cancer screening
Time frame: 30 days
1 secondary outcome
colorectal cancer screening knowledge
Time frame: 30 days
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 7 Sep 2012.
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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.
John M. Westfall, MD, MPH principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing small media, group education (multicomponent) in people with Colorectal Cancer, run by Centers for Disease Control and Prevention 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 0 inclusion and 1 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 7 Sep 2012. 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?
colorectal cancer screening (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2012.