ColoRectal CancerNCT03031171
Community Engaged Colon Cancer Screening Patient Navigator Program
A study testing Screening patient navigation and Non-Navigated in people with ColoRectal Cancer, run by University of Nevada, Reno at 1 site in United States.
Trial summary
The goal of the project is to increase colorectal cancer screening within the priority population of female and male adults age 50 to 85 in Northern Nevada. A successful community-based cancer patient navigator program will be modified in partnership with the community into a multi-level screening intervention. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- ColoRectal Cancer
- What is being tested?
- Screening patient navigation and Non-Navigated
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 415 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Sep 2011
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Insurance, no history of colon cancer,
Who cannot join
- No experience of relevant GI symptoms
Trial locations and contacts
1 site in 1 country.
About this study
The goal of the project is to increase colorectal cancer screening within the priority population of female and male adults age 50 to 85 in Northern Nevada. A successful community-based cancer patient navigator program will be modified in partnership with the community into a multi-level screening intervention.
Read the detailed description
The goal of the project is to increase colorectal cancer screening within the priority population of female and male adults age 50 to 85 in Northern Nevada. A successful community-based cancer patient navigator program will be modified in partnership with the community into a multi-level screening intervention. A well-tested behavioral change theory (the health belief model; HBM) will guide the intervention and the relative efficacy of a) the theory's constructs and b) evidence-based intervention practices on increasing screening rates will be examined. Although increased screening rates are associated with program navigators, it is unclear which program components are related to the outcome. In addition, there is ambiguity surrounding a) the temporal impact of the HBM on cancer screening and b) the relationships among the model's constructs. A quasi-experimental time-series design will be used to evaluate the outcome objective of increased screening rates by comparing screening rates one year pre- and post-intervention and whether navigated patients are better prepared for screening than non-navigated patients. A minimum of 315 participants (to correspond with a power level of .80) in the navigator program will be surveyed on knowledge about colorectal cancer, and satisfaction with and usefulness of the program. The anticipated contribution of the project will be to increase community efficacy, colorectal cancer screening in the project area, and to reduce cancer morbidity and mortality.
- Conditions
- ColoRectal Cancer
- Being tested
- Screening patient navigation, Non-Navigated
- Keywords
- community engagement, navigation, cancer screening
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening patient navigationBehavioural
The program offered assistance with scheduling, paperwork, arranging transportation, answering questions and providing education about screening and colorectal cancer.
Non-NavigatedBehavioural
Randomly matched sample of non-navigated clinic patients
| Study group | Role | What they receive |
|---|---|---|
| Navigated: Screening patient navigation | Experimental | Clinic patients who received navigation Receives: Behavioral: Screening patient navigation |
| Non-Navigated | Active comparator | Randomly matched sample of non-navigated clinic patients Receives: Behavioral: Non-Navigated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonoscopy completion
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study startApr 2010
- Primary completionAug 2011
- Study completionSep 2011
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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Reno
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of California, Davis, National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Paul Devereux, PhD, MPH, Principal investigator, University of Nevada, Reno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031171
- Sponsor's protocol ID
- SB09/10-034
- Other IDs
- 8P20GM103440-11
- Status last verified
- Nov 2016
- First submitted
- 21 Jan 2017
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Engaged Colon Cancer Screening Patient Navigator Program
- ClinicalTrials.gov ID
- NCT03031171
- Acronym / sponsor ID
- SB09/10-034
- Conditions
- ColoRectal Cancer
- Keywords
- community engagement, navigation, cancer screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- University of Nevada, RenoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of California, Davis, National Institute of General Medical Sciences (NIGMS)
- Study start
- Apr 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 25 Jan 2017 (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.
The goal of the project is to increase colorectal cancer screening within the priority population of female and male adults age 50 to 85 in Northern Nevada. A successful community-based cancer patient navigator program will be modified in partnership with the community into a multi-level screening intervention.
Detailed description
The goal of the project is to increase colorectal cancer screening within the priority population of female and male adults age 50 to 85 in Northern Nevada. A successful community-based cancer patient navigator program will be modified in partnership with the community into a multi-level screening intervention. A well-tested behavioral change theory (the health belief model; HBM) will guide the intervention and the relative efficacy of a) the theory's constructs and b) evidence-based intervention practices on increasing screening rates will be examined. Although increased screening rates are associated with program navigators, it is unclear which program components are related to the outcome. In addition, there is ambiguity surrounding a) the temporal impact of the HBM on cancer screening and b) the relationships among the model's constructs. A quasi-experimental time-series design will be used to evaluate the outcome objective of increased screening rates by comparing screening rates one year pre- and post-intervention and whether navigated patients are better prepared for screening than non-navigated patients. A minimum of 315 participants (to correspond with a power level of .80) in the navigator program will be surveyed on knowledge about colorectal cancer, and satisfaction with and usefulness of the program. The anticipated contribution of the project will be to increase community efficacy, colorectal cancer screening in the project area, and to reduce cancer morbidity and mortality.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Navigated: Screening patient navigation | Experimental | Behavioral: Screening patient navigationClinic patients who received navigation |
| Non-Navigated | Active comparator | Behavioral: Non-NavigatedRandomly matched sample of non-navigated clinic patients |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Insurance, no history of colon cancer,
Key exclusion criteria (1 listed)
- No experience of relevant GI symptoms
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 |
|---|---|---|
| Screening patient navigationThe program offered assistance with scheduling, paperwork, arranging transportation, answering questions and providing education about screening and colorectal cancer. | Behavioural | Navigated: Screening patient navigation |
| Non-NavigatedRandomly matched sample of non-navigated clinic patients | Behavioural | Non-Navigated |
Primary outcome
Colonoscopy completion
Time frame: 2 years
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 25 Jan 2017.
- 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.
Paul Devereux, PhD, MPH principal investigator
University of Nevada, Reno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening patient navigation and Non-Navigated in people with ColoRectal Cancer, run by University of Nevada, Reno 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 1 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 25 Jan 2017. 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?
Colonoscopy completion (time frame: 2 years). 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 25 Jan 2017.