Colon CancerNCT03457454
Reducing Rural Colon Cancer Disparities
An observational study of Colon Cancer, run by Washington University School of Medicine at 2 sites in United States.
Trial summary
The investigators will conduct pre-implementations assessments of primary care clinics within a rural health system to determine current practices and capacities regarding colorectal cancer (CRC) screening and follow-up, preferred evidence-based interventions (EBIs) to improve follow-up, and factors that could… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Primary Care Provider/Staff Participants Interview, Patient Participant Interview and Patient Participant Anonymous Survey
- How many people
- 431 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Sep 2017to 18 Mar 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary Care Providers/Staff Participants, Patient Participants, and Colonoscopy Provider/Staff Participants from Southern Illinois Healthcare.
Who may be able to join
- -Positive FOBT or colonoscopy
- 50 years of age or older
- Had a colonoscopy at one of Southern Illinois Healthcare's facilities within the last 24 months
- Inclusion Criteria for Colonoscopy Provider/Staff Participants -Provider and a staff or mid-level provider in each office (5 colonoscopy providers in the Southern Illinois Healthcare region)
- Exclusion Criteria for Primary Care Provider/Staff Participants
- -None
Who cannot join
- Negative FOBT or colonoscopy
- Younger than 50 years of age
- Exclusion Criteria for Colonoscopy Provider/Staff Participants None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Southern Illinois Healthcare
Carbondale, Illinois, 62901
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Reducing Rural Colon Cancer Disparities Through Multi-level Interventions in Follow-up After Abnormal Screening Tests
The investigators will conduct pre-implementations assessments of primary care clinics within a rural health system to determine current practices and capacities regarding colorectal cancer (CRC) screening and follow-up, preferred evidence-based interventions (EBIs) to improve follow-up, and factors that could influence successful implementation and eventual impact of a multi-level intervention to increase timely and complete follow-up after positive fecal occult blood test (FOBT) in rural patients.
- Conditions
- Colon Cancer
- Being tested
- Primary Care Provider/Staff Participants Interview, Patient Participant Interview, Patient Participant Anonymous Survey, Colonoscopy Provider/Staff Participants Interviews
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Care Provider/Staff Participants InterviewOther
-Approximately a 30 minute interview
Patient Participant InterviewOther
-Approximately 45-60 minute interview
Patient Participant Anonymous SurveyOther
-Survey completion will take approximately 15 minutes
Colonoscopy Provider/Staff Participants InterviewsOther
-Approximately a 30 minute interview
| Study group | Role | What they receive |
|---|---|---|
| Primary Care Provider/Staff Participants Interviews | * Up to two primary care providers and at least one staff person at each of the 16 clinics, with approximately 5 interviewees per clinic. Eligible providers and staff include physicians, nurse practitioners, nurses, case managers, medical assistants, administrative staff, or other employees of the clinic involved in the cancer screening and follow-up process.
* If the participant verbally consents, the research team member will conduct an interview with the provider to learn about the current processes used to support and monitor colorectal cancer screening (CRC) from screening initiation through follow-up; assess capacity and interest in implementing Evidence Based Practices for supporting and monitoring CRC screening, including any ideas interviewees have or find appealing; and engage the organizations as partners to build interest, capacity, and infrastructure for future intervention trial and other future studies. Receives: Other: Primary Care Provider/Staff Participants Interview | |
| Patient Participants Interviews | * 10 patients across 5 clinics will be recruited for interviews, which will address the patient experience with screening and follow-up.
* If the participant verbally consents, the research team member will conduct an interview with the patient participant to gain a deeper understanding of the CRC screening process from the patient's perspective; the gaps, challenges, or road blocks/speed bumps to completing CRC screening steps; and what organizations can do better or differently to help people complete the CRC screening process. Receives: Other: Patient Participant Interview | |
| Patient Participants Anonymous Survey | -Patient participants will be recruited to take an anonymous mailed survey, which will address patient level barriers to screening and follow-up focusing on out of pocket costs. Receives: Other: Patient Participant Anonymous Survey | |
| Colonoscopy Provider/Staff Participants Interviews | * Colonoscopy providers and a staff or mid-level provider in each office will be recruited for interviews.
* If the participant consents, the research team member will conduct an interview to learn about current processes used to support and monitor colorectal cancer screening from the perspective of gastroenterology/colonoscopy sites and to learn about how gastroenterology/colonoscopy sites communicate and coordinate care with other healthcare organizations and patients to support and monitor colorectal cancer screening. Receives: Other: Colonoscopy Provider/Staff Participants Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine current practice and capacity regarding screening and follow-up of colorectal cancer screening at rural health clinics
-This will be measured by interviews
Measured: Through completion of study (estimated to be 18 months)
Assess factors that could influence implementation of multi-level EBIs
-This will be measured by interviews
Measured: Through completion of study (estimated to be 18 months)
Evaluate the capacity for colonoscopy and diagnostic follow-up by identifying those clinics/practitioners who deliver colonoscopy
-This will be measured by interviews
Measured: Through completion of study (estimated to be 18 months)
Assess the care coordination and communication with primary care providers by colonoscopy clinics/practitioners
-This will be measured by interviews
Measured: Through completion of study (estimated to be 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start8 Sep 2017
- Primary completion18 Mar 2021
- Study completion18 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 431 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Aimee James, Ph.D., MPH, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457454
- Sponsor's protocol ID
- 201704046
- Other IDs
- U01CA209861-01A1
- Status last verified
- Mar 2021
- First submitted
- 1 Mar 2018
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Rural Colon Cancer Disparities Through Multi-level Interventions in Follow-up After Abnormal Screening Tests
- ClinicalTrials.gov ID
- NCT03457454
- Acronym / sponsor ID
- 201704046
- Conditions
- Colon Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 431 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 8 Sep 2017 (actual)
- Primary completion
- 18 Mar 2021 (actual)
- Study completion
- 18 Mar 2021 (actual)
- First posted
- 7 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.
The investigators will conduct pre-implementations assessments of primary care clinics within a rural health system to determine current practices and capacities regarding colorectal cancer (CRC) screening and follow-up, preferred evidence-based interventions (EBIs) to improve follow-up, and factors that could influence successful implementation and eventual impact of a multi-level intervention to increase timely and complete follow-up after positive fecal occult blood test (FOBT) in rural patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Primary Care Provider/Staff Participants Interviews | – | Other: Primary Care Provider/Staff Participants Interview* Up to two primary care providers and at least one staff person at each of the 16 clinics, with approximately 5 interviewees per clinic. Eligible providers and staff include physicians, nurse practitioners, nurses, case managers, medical assistants, administrative staff, or other employees of the clinic involved in the cancer screening and follow-up process. * If the participant verbally consents, the research team member will conduct an interview with the provider to learn about the current processes used to support and monitor colorectal cancer screening (CRC) from screening initiation through follow-up; assess capacity and interest in implementing Evidence Based Practices for supporting and monitoring CRC screening, including any ideas interviewees have or find appealing; and engage the organizations as partners to build interest, capacity, and infrastructure for future intervention trial and other future studies. |
| Patient Participants Interviews | – | Other: Patient Participant Interview* 10 patients across 5 clinics will be recruited for interviews, which will address the patient experience with screening and follow-up. * If the participant verbally consents, the research team member will conduct an interview with the patient participant to gain a deeper understanding of the CRC screening process from the patient's perspective; the gaps, challenges, or road blocks/speed bumps to completing CRC screening steps; and what organizations can do better or differently to help people complete the CRC screening process. |
| Patient Participants Anonymous Survey | – | Other: Patient Participant Anonymous Survey-Patient participants will be recruited to take an anonymous mailed survey, which will address patient level barriers to screening and follow-up focusing on out of pocket costs. |
| Colonoscopy Provider/Staff Participants Interviews | – | Other: Colonoscopy Provider/Staff Participants Interviews* Colonoscopy providers and a staff or mid-level provider in each office will be recruited for interviews. * If the participant consents, the research team member will conduct an interview to learn about current processes used to support and monitor colorectal cancer screening from the perspective of gastroenterology/colonoscopy sites and to learn about how gastroenterology/colonoscopy sites communicate and coordinate care with other healthcare organizations and patients to support and monitor colorectal cancer screening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Providers/Staff Participants, Patient Participants, and Colonoscopy Provider/Staff Participants from Southern Illinois Healthcare.
Key inclusion criteria (6 listed)
- -Positive FOBT or colonoscopy
- 50 years of age or older
- Had a colonoscopy at one of Southern Illinois Healthcare's facilities within the last 24 months
- Inclusion Criteria for Colonoscopy Provider/Staff Participants -Provider and a staff or mid-level provider in each office (5 colonoscopy providers in the Southern Illinois Healthcare region)
- Exclusion Criteria for Primary Care Provider/Staff Participants
Key exclusion criteria (3 listed)
- Negative FOBT or colonoscopy
- Younger than 50 years of age
- Exclusion Criteria for Colonoscopy Provider/Staff Participants None
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 |
|---|---|---|
| Primary Care Provider/Staff Participants Interview-Approximately a 30 minute interview | Other | Primary Care Provider/Staff Participants Interviews |
| Patient Participant Interview-Approximately 45-60 minute interview | Other | Patient Participants Interviews |
| Patient Participant Anonymous Survey-Survey completion will take approximately 15 minutes | Other | Patient Participants Anonymous Survey |
| Colonoscopy Provider/Staff Participants Interviews-Approximately a 30 minute interview | Other | Colonoscopy Provider/Staff Participants Interviews |
Primary outcome
Determine current practice and capacity regarding screening and follow-up of colorectal cancer screening at rural health clinics
Time frame: Through completion of study (estimated to be 18 months)
-This will be measured by interviews
Assess factors that could influence implementation of multi-level EBIs
Time frame: Through completion of study (estimated to be 18 months)
-This will be measured by interviews
Evaluate the capacity for colonoscopy and diagnostic follow-up by identifying those clinics/practitioners who deliver colonoscopy
Time frame: Through completion of study (estimated to be 18 months)
-This will be measured by interviews
Assess the care coordination and communication with primary care providers by colonoscopy clinics/practitioners
Time frame: Through completion of study (estimated to be 18 months)
-This will be measured by interviews
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 Apr 2021.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- 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.
Aimee James, Ph.D., MPH principal investigator
Washington University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer, run by Washington University School of Medicine at 2 sites 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 6 inclusion and 3 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 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Determine current practice and capacity regarding screening and follow-up of colorectal cancer screening at rural health clinics (time frame: Through completion of study (estimated to be 18 months)). The study lists 4 primary outcomes in all. 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 1 Apr 2021.