Colorectal CancerNCT03473587
Promoting Colorectal Cancer Screening in Rural Emergency Departments
A study testing Motivational interview in people with Colorectal Cancer, run by University of Kentucky at 1 site in United States.
Trial summary
This trial will compare the effects of a culturally targeted intervention designed to assist participants to identify and overcome individual barriers to colorectal cancer (CRC) and to promote CRC screenings using motivational interviewing (Ml) delivered by a lay health advisor (LHA) compared to the current… 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?
- Motivational interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2014to 30 May 2018
- 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
- 50+ years of age
- Rural Appalachian resident
- No personal history of colorectal cancer
- No cognitive impairment
- Ability to speak and understand English
- Has not had one of the following colorectal cancer screening tests--
Show all 9Show fewer
- Fecal Occult Blood Test within the past year
- Flexible sigmoidoscopy within the past five years, or
- Colonoscopy within the past ten years
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
St. Clair Regional Medical Center
Morehead, Kentucky, 40351
Jennifer Hatcher, RN, PhD, 859-257-5263, jennifer.hatcher@uky.edu
About this study
This trial will compare the effects of a culturally targeted intervention designed to assist participants to identify and overcome individual barriers to colorectal cancer (CRC) and to promote CRC screenings using motivational interviewing (Ml) delivered by a lay health advisor (LHA) compared to the current standard-of-care (distribution of a brochure describing CRC screening services offered by the hospital) on CRC screening compliance.
Read the detailed description
The specific aim of this project is to adapt and pilot a tailored intervention to promote CRC screenings in a rural Appalachian Kentucky emergency department (ED) in order to: (a) evaluate the feasibility of providing a cancer screening promotion intervention in an emergency department (ED) that serves a rural Appalachian community; and (b) assess the effects of the intervention on barriers to CRC screening, stage of readiness to screen and CRC screening engagement. The first phase of the project will involve the adaptation and pretesting of the intervention. This phase will take approximately 6 months. The second phase of the project will involve piloting the intervention and evaluating its efficacy and feasibility and will take place over the following 18 months. We will conduct a randomized controlled trial to examine the efficacy and feasibility of delivering the LHA delivered MI intervention to promote CRC screening in persons waiting in a rural Appalachian emergency department (ED) for non urgent complaints. We will evaluate efficacy by measurement of CRC screening status at baseline and three and six months post intervention.
- Conditions
- Colorectal Cancer
- Being tested
- Motivational interview, Standard of care
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewBehavioural
A lay health advisor will engage the subject in a motivational interview to promote the importance of colorectal cancer screening
Standard of careBehavioural
A lay health advisor will provide the subject with a brochure promoting the importance of colorectal cancer screening
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interview | Experimental | Subjects will engage in a brief motivational interview to establish an action plan and discuss follow-up interviews a 3 and 6 months post ED visit Receives: Behavioral: Motivational interview |
| Standard of Care | Active comparator | Subjects will be provided a standard of care colorectal cancer screening brochure at the time of ED visit Receives: Behavioral: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in colorectal cancer screening rate
Number of participants that seek out colorectal cancer screening after a motivational interview with a lay health advisor compared to standard of care (being provided a screening brochure)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start7 Nov 2014
- Primary completion30 May 2018 (estimated)
- Study completion30 May 2018 (estimated)
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 191 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Hatcher, University of Kentucky
- Investigators
- Jennifer Hatcher, RN, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473587
- Sponsor's protocol ID
- MCC-14-0681-P1H
- Status last verified
- Mar 2018
- First submitted
- 18 Jan 2018
- Last updated
- 22 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Colorectal Cancer Screening in Rural Emergency Departments
- ClinicalTrials.gov ID
- NCT03473587
- Acronym / sponsor ID
- MCC-14-0681-P1H
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 191 participants (estimated)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Study start
- 7 Nov 2014 (actual)
- Primary completion
- 30 May 2018 (estimated)
- Study completion
- 30 May 2018 (estimated)
- First posted
- 22 Mar 2018 (actual)
- 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 trial will compare the effects of a culturally targeted intervention designed to assist participants to identify and overcome individual barriers to colorectal cancer (CRC) and to promote CRC screenings using motivational interviewing (Ml) delivered by a lay health advisor (LHA) compared to the current standard-of-care (distribution of a brochure describing CRC screening services offered by the hospital) on CRC screening compliance.
Detailed description
The specific aim of this project is to adapt and pilot a tailored intervention to promote CRC screenings in a rural Appalachian Kentucky emergency department (ED) in order to: (a) evaluate the feasibility of providing a cancer screening promotion intervention in an emergency department (ED) that serves a rural Appalachian community; and (b) assess the effects of the intervention on barriers to CRC screening, stage of readiness to screen and CRC screening engagement. The first phase of the project will involve the adaptation and pretesting of the intervention. This phase will take approximately 6 months. The second phase of the project will involve piloting the intervention and evaluating its efficacy and feasibility and will take place over the following 18 months. We will conduct a randomized controlled trial to examine the efficacy and feasibility of delivering the LHA delivered MI intervention to promote CRC screening in persons waiting in a rural Appalachian emergency department (ED) for non urgent complaints. We will evaluate efficacy by measurement of CRC screening status at baseline and three and six months post intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interview | Experimental | Behavioral: Motivational interviewSubjects will engage in a brief motivational interview to establish an action plan and discuss follow-up interviews a 3 and 6 months post ED visit |
| Standard of Care | Active comparator | Behavioral: Standard of careSubjects will be provided a standard of care colorectal cancer screening brochure at the time of ED visit |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 50+ years of age
- Rural Appalachian resident
- No personal history of colorectal cancer
- No cognitive impairment
- Ability to speak and understand English
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Motivational interviewA lay health advisor will engage the subject in a motivational interview to promote the importance of colorectal cancer screening | Behavioural | Motivational Interview |
| Standard of careA lay health advisor will provide the subject with a brochure promoting the importance of colorectal cancer screening | Behavioural | Standard of Care |
Primary outcome
Change in colorectal cancer screening rate
Time frame: 6 months
Number of participants that seek out colorectal cancer screening after a motivational interview with a lay health advisor compared to standard of care (being provided a screening brochure)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
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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.
Jennifer Hatcher, RN, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interview in people with Colorectal Cancer, run by University of Kentucky 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 9 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: status not confirmed, as of the sponsor's last update on 22 Mar 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Hatcher, RN, PhD (859-257-5263, jennifer.hatcher@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in colorectal cancer screening rate (time frame: 6 months). 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 22 Mar 2018.