Colorectal CancerNCT05453630
Colonoscopy Outreach for Rural Communities Aim 2
A study testing Patient Navigation in people with Colorectal Cancer, run by University of Washington at 1 site in United States.
Trial summary
This study aims to test the effectiveness of a remotely-delivered patient navigation program for increasing colonoscopy completion for colorectal cancer screening, among rural populations. The study will partner with geographically disparate primary care organizations to recruit patients aged 45-75 to the study. Read more about this study
- Who is it for?
- Ages 45 years to 915 monthsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Patient Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 527 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2022to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years to 915 months
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 45-76.25 on the date of their referral for colonoscopy
- Referred for colonoscopy as part of colorectal cancer screening in the last 3 months. This includes patients referred for colonoscopy after an abnormal stool screening test (e.g., FIT/FOBT/Cologuard) and patients referred for colonoscopy as a primary screening test for colorectal cancer.
Who cannot join
- Deceased
- Colonoscopy procedure since colonoscopy referral
- Colonoscopy procedure scheduled less than or equal to 7 days from study enrollment date
- Colonoscopy procedure scheduled more than 9 months from colonoscopy referral date (if known at enrollment)
- Have diagnosis or past history of total colectomy or colorectal cancer (malignant neoplasm) at any time
- Has hospice
- Aged 66 and older living long-term in an institution for more than 90 consecutive days during the year prior to the query
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to test the effectiveness of a remotely-delivered patient navigation program for increasing colonoscopy completion for colorectal cancer screening, among rural populations. The study will partner with geographically disparate primary care organizations to recruit patients aged 45-75 to the study. The patient navigation program will be delivered through a community organization. This project is critical in advancing our knowledge of the effectiveness of patient navigation for increasing colonoscopy in this patient population as well as for understanding factors that can support long term implementation and sustainability of effective interventions.
Read the detailed description
Colorectal cancer (CRC) is a leading cause of cancer death in the United States and its burden is greater in rural and low-income communities. Failure to complete recommended colonoscopy contributes to later-stage CRC diagnosis and worse CRC outcomes, which means timely and successful colonoscopy is a key opportunity to reduce CRC mortality. Using a Type 1 Hybrid Implementation-Effectiveness design, we will randomize 480-600 subjects from 6-8 primary care clinical organizations in a randomized controlled trial (RCT) to accomplish the following:
- Test the effectiveness of a patient navigation program, remotely-delivered by a community-based organization, for increasing colonoscopy completion rates for colorectal cancer screening among rural patients.
- Assess implementation and sustainability of the patient navigation program from the perspectives of both community and clinical stakeholders.
- Conditions
- Colorectal Cancer
- Being tested
- Patient Navigation, Usual Care Control
- Keywords
- colorectal cancer, patient navigation, colonoscopy, FIT, fecal immunochemical test, immunochemical fecal occult blood test, implementation effectiveness, colorectal 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.
Patient NavigationBehavioural
Patients will receive navigation from a trained lay navigator at a community-based nonprofit organization that supports access to high quality healthcare. The patient navigator will work with patients to schedule their colonoscopy and identify, explore, and overcome barriers. They will educate patients about the colonoscopy procedure and preparation, provide resources, and coach and motivate patients.
Usual Care ControlBehavioural
Educational brochure about colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Patient Navigation Intervention | Experimental | Patients randomized to this arm will receive language-concordant patient navigation from a trained navigator, over the phone and via text and email, to assist patients to complete colonoscopy to screen for colorectal cancer. Receives: Behavioral: Patient Navigation |
| Standard of Care Control | Other | Participants randomized to this arm will receive an educational brochure about the importance of colonoscopy to screen for colorectal cancer. Receives: Behavioral: Usual Care Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Complete Colonoscopy Within 1 Year of the Colonoscopy Referral
Number of participants who received a colonoscopy within 12 months (365 days) of their referral for the procedure. Electronic health record documentation of the procedure (e.g., procedure report, pathology report, results letter) or self-report was used to determine whether the patient received the colonoscopy.
Measured: 1 year
Secondary outcomes (5)
Number of Participants Who Complete Colonoscopy Within 9 Months of the Colonoscopy Referral
Number of participants who received a colonoscopy within 9 months (274 days) of their referral for the procedure. Electronic health record documentation of the procedure (e.g., procedure report, pathology report, results letter) or self-report was used to determine whether the patient received the colonoscopy.
Measured: 9 months
Number of Participants Who Complete Colonoscopy Within 6 Months of the Colonoscopy Referral
Number of participants who received a colonoscopy within 6 months (183 days) of their referral for the procedure. Electronic health record documentation of the procedure (e.g., procedure report, pathology report, results letter) or self-report was used to determine whether the patient received the colonoscopy.
Measured: 6 months
Time to Completion of Colonoscopy or End of Follow-up After the Colonoscopy Referral
Kaplan-Meier estimated median days to completion. Based on the number of days to colonoscopy completion or end of the 12 month (365 day) follow-up period, from the participant's referral for the procedure. Electronic health record documentation of the procedure (e.g., procedure report, pathology report, results letter) or self-report was used to determine whether the patient received the colonoscopy.
Measured: 1 year
Number of Participants Who Have Completed Colonoscopies With Adequate Preparation
Number of participants who received a colonoscopy within 12 months of their referral who had documentation of adequate bowel preparation in their electronic health record. Adequate bowel preparation was defined as a subjective rating of fair, adequate, good, or excellent; or a Boston Bowel Preparation Score (BBPS) total of 6 or higher. The BBPS scale ranges from 0-9 with higher values indicating better preparation.
Measured: 1 year
Number of Participants Who Have Colonoscopies With Cecal Intubation
Number of participants who received a colonoscopy within 12 months of their referral who had documentation of cecal intubation in their electronic health record. Cecal intubation was considered achieved if there was text documenting reaching the cecum or photographic documentation labeled with cecal landmarks in the procedure information.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start16 Jun 2022
- Primary completion15 Jul 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 527 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Alison Cole, University of Washington
- Investigators
- Allison M Cole, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453630
- Sponsor's protocol ID
- STUDY00014807
- Other IDs
- 1R01CA254515-01
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2022
- Last updated
- 15 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A data dictionary and cleaned, de-identified, data used to conduct the final analyses may be made available to researchers who provide a reasonable proposal. Data will be limited to the scope of the proposal.
Publications
Ike B, Keppel GA, Cole A. Rural barriers to colonoscopy screening identified through patient navigation. PEC Innov. 2026 Apr 3;8:100475. doi: 10.1016/j.pecinn.2026.100475. eCollection 2026 Jun.
PubMed 42005421Keppel GA, Ike B, Leroux BG, Ko LK, Osterhage KP, Jacobs JD, Cole AM. Colonoscopy Outreach for Rural Communities (CORC): A study protocol of a pragmatic randomized controlled trial of a patient navigation program to improve colonoscopy completion for colorectal cancer screening. Contemp Clin Trials. 2024 Jun;141:107539. doi: 10.1016/j.cct.2024.107539. Epub 2024 Apr 12.
PubMed 38615750Ike B, Keppel GA, Osterhage KP, Ko LK, Cole A. Adapting a Remotely Delivered Patient Navigation Program for Colorectal Cancer Screening in Primary Care: Important Considerations for Rural Contexts. J Prim Care Community Health. 2024 Jan-Dec;15:21501319241288025. doi: 10.1177/21501319241288025.
PubMed 39439281
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonoscopy Outreach for Rural Communities Aim 2
- ClinicalTrials.gov ID
- NCT05453630
- Acronym / sponsor ID
- STUDY00014807
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, patient navigation, colonoscopy, FIT, fecal immunochemical test, immunochemical fecal occult blood test, implementation effectiveness, colorectal cancer screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 527 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 12 Jul 2022 (actual)
- Results
- Posted 15 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to test the effectiveness of a remotely-delivered patient navigation program for increasing colonoscopy completion for colorectal cancer screening, among rural populations. The study will partner with geographically disparate primary care organizations to recruit patients aged 45-75 to the study. The patient navigation program will be delivered through a community organization. This project is critical in advancing our knowledge of the effectiveness of patient navigation for increasing colonoscopy in this patient population as well as for understanding factors that can support long term implementation and sustainability of effective interventions.
Detailed description
Colorectal cancer (CRC) is a leading cause of cancer death in the United States and its burden is greater in rural and low-income communities. Failure to complete recommended colonoscopy contributes to later-stage CRC diagnosis and worse CRC outcomes, which means timely and successful colonoscopy is a key opportunity to reduce CRC mortality. Using a Type 1 Hybrid Implementation-Effectiveness design, we will randomize 480-600 subjects from 6-8 primary care clinical organizations in a randomized controlled trial (RCT) to accomplish the following:
- Test the effectiveness of a patient navigation program, remotely-delivered by a community-based organization, for increasing colonoscopy completion rates for colorectal cancer screening among rural patients.
- Assess implementation and sustainability of the patient navigation program from the perspectives of both community and clinical stakeholders.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Navigation Intervention | Experimental | Behavioral: Patient NavigationPatients randomized to this arm will receive language-concordant patient navigation from a trained navigator, over the phone and via text and email, to assist patients to complete colonoscopy to screen for colorectal cancer. |
| Standard of Care Control | Other | Behavioral: Usual Care ControlParticipants randomized to this arm will receive an educational brochure about the importance of colonoscopy to screen for colorectal cancer. |
Who may qualify
- Ages
- 45 years to 915 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 45-76.25 on the date of their referral for colonoscopy
- Referred for colonoscopy as part of colorectal cancer screening in the last 3 months. This includes patients referred for colonoscopy after an abnormal stool screening test (e.g., FIT/FOBT/Cologuard) and patients referred for colonoscopy as a primary screening test for colorectal cancer.
Key exclusion criteria (7 listed)
- Deceased
- Colonoscopy procedure since colonoscopy referral
- Colonoscopy procedure scheduled less than or equal to 7 days from study enrollment date
- Colonoscopy procedure scheduled more than 9 months from colonoscopy referral date (if known at enrollment)
- Have diagnosis or past history of total colectomy or colorectal cancer (malignant neoplasm) at any time
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 |
|---|---|---|
| Patient NavigationPatients will receive navigation from a trained lay navigator at a community-based nonprofit organization that supports access to high quality healthcare. The patient navigator will work with patients to schedule their colonoscopy and identify, explore, and overcome barriers. They will educate patients about the colonoscopy procedure and preparation, provide resources, and coach and motivate patients. | Behavioural | Patient Navigation Intervention |
| Usual Care ControlEducational brochure about colonoscopy | Behavioural | Standard of Care Control |
Primary outcome
Number of Participants Who Complete Colonoscopy Within 1 Year of the Colonoscopy Referral
Time frame: 1 year
Number of participants who received a colonoscopy within 12 months (365 days) of their referral for the procedure. Electronic health record documentation of the procedure (e.g., procedure report, pathology report, results letter) or self-report was used to determine whether the patient received the colonoscopy.
5 secondary outcomes
Number of Participants Who Complete Colonoscopy Within 9 Months of the Colonoscopy Referral
Time frame: 9 months
Number of Participants Who Complete Colonoscopy Within 6 Months of the Colonoscopy Referral
Time frame: 6 months
Time to Completion of Colonoscopy or End of Follow-up After the Colonoscopy Referral
Time frame: 1 year
Number of Participants Who Have Completed Colonoscopies With Adequate Preparation
Time frame: 1 year
Number of Participants Who Have Colonoscopies With Cecal Intubation
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 42005421Ike B, Keppel GA, Cole A. Rural barriers to colonoscopy screening identified through patient navigation. PEC Innov. 2026 Apr 3;8:100475. doi: 10.1016/j.pecinn.2026.100475. eCollection 2026 Jun.
- Background: PubMed 38615750Keppel GA, Ike B, Leroux BG, Ko LK, Osterhage KP, Jacobs JD, Cole AM. Colonoscopy Outreach for Rural Communities (CORC): A study protocol of a pragmatic randomized controlled trial of a patient navigation program to improve colonoscopy completion for colorectal cancer screening. Contemp Clin Trials. 2024 Jun;141:107539. doi: 10.1016/j.cct.2024.107539. Epub 2024 Apr 12.
- Background: PubMed 39439281Ike B, Keppel GA, Osterhage KP, Ko LK, Cole A. Adapting a Remotely Delivered Patient Navigation Program for Colorectal Cancer Screening in Primary Care: Important Considerations for Rural Contexts. J Prim Care Community Health. 2024 Jan-Dec;15:21501319241288025. doi: 10.1177/21501319241288025.
- Individual participant dataSharing planned: Yes. A data dictionary and cleaned, de-identified, data used to conduct the final analyses may be made available to researchers who provide a reasonable proposal. Data will be limited to the scope of the proposal.
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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.
Allison M Cole, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigation in people with Colorectal Cancer, run by University of Washington 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 2 inclusion and 7 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 15 Jul 2026. 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?
Yes. Results are posted in the registry (first posted 15 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Complete Colonoscopy Within 1 Year of the Colonoscopy Referral (time frame: 1 year). 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 NCT05453630, 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 15 Jul 2026.