Stage I Colorectal Cancer AJCC v8NCT06995924
Improving Uptake of Surveillance in Colorectal Cancer Survivors Through Navigation and Web Education
A study testing Educational Intervention, Electronic Health Record Review and Internet-Based Intervention in people with Stage I Colorectal Cancer AJCC v8 and Stage II Colorectal Cancer AJCC v8, run by Fred Hutchinson Cancer Center at 2 sites in United States.
Trial summary
This pilot clinical trial looks at whether patient navigation services, an interactive web education intervention, called Current Together After Cancer (CTAC), or both navigation and CTAC works to improve the uptake of surveillance in patients with stage I-III colorectal cancer (CRC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage I Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8
- What is being tested?
- Educational Intervention, Electronic Health Record Review and Internet-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Nov 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 due to disease and clinic population
- Stage I-III CRC survivor within 3 months post-surgical resection
- Being seen at a participating clinic
- Ability to understand and complete surveys in English
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Benaroya Research Institute at Virginia Mason
Seattle, Washington, 98101
Vlad Simianu, MD, MPH, FACS, FASCRS
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Ari Bell-Brown, 206-667-7624, abellbro@fredhutch.org
Rachel B. Issaka, MD, MAS
About this study
Official title: A Pilot Trial to Evaluate the Effectiveness of Navigation, Interactive Web Education, or the Combination of Both to Promote Guideline-Concordant Colorectal Cancer Surveillance Care
This pilot clinical trial looks at whether patient navigation services, an interactive web education intervention, called Current Together After Cancer (CTAC), or both navigation and CTAC works to improve the uptake of surveillance in patients with stage I-III colorectal cancer (CRC). Post-treatment surveillance is critical to detect recurrence early, yet many CRC survivors do not receive recommended surveillance care. Surveillance is a complex process that includes laboratory tests, cross-sectional imaging, and endoscopic procedures. Patient navigation services, interactive web education, or a combination of both may improve surveillance care for patients with stage I-III colorectal cancer.
Read the detailed description
OUTLINE:
Patients are assigned to 1 of 3 arms based on the clinic location they receive cancer care at.
ARM A: Patients receive access to navigation services, including education on surveillance care, reminders to complete care and assistance in scheduling surveillance, within 3 months of standard of care surgical resection for stage I-III CRC.
ARM B: Patients receive access to the CTAC intervention, which includes self-directed, interactive web-based education about surveillance and a checklist of care, within 3 months of standard of care surgical resection for stage I-III CRC.
ARM C: Patients receive access to navigation services, including education on surveillance care, reminders to complete care and assistance in scheduling surveillance, and access to the CTAC intervention, which includes self-directed, interactive web-based education about surveillance and a checklist of care, within 3 months of standard of care surgical resection for stage I-III CRC.
Patients are followed up at 3 months post study-enrollment and 12-18 months after surgical resection.
- Conditions
- Stage I Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8
- Being tested
- Educational Intervention, Electronic Health Record Review, Internet-Based Intervention, Patient Navigation, Survey Administration
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Complete self-directed interactive education
Electronic Health Record ReviewOther
Ancillary studies
Internet-Based InterventionOther
Receive access to CTAC
Patient NavigationBehavioural
Also called Patient Navigator Program
Receive patient navigation services
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm A (navigation) | Experimental | Patients receive access to navigation services, in person, via telephone or via electronic conferencing platform, including education on surveillance care, reminders to complete care and assistance in scheduling surveillance, within 3 months of standard of care surgical resection. Receives: Other: Electronic Health Record Review; Behavioral: Patient Navigation; Other: Survey Administration |
| Arm B (CTAC) | Experimental | Patients receive access to the online CTAC intervention, which includes self-directed, interactive education about surveillance and a checklist of care, within 3 months of standard of care surgical resection. Receives: Other: Educational Intervention; Other: Electronic Health Record Review; Other: Internet-Based Intervention; Other: Survey Administration |
| Arm C (navigation and CTAC) | Experimental | Patients receive access to navigation services, in person, via telephone or via electronic conferencing platform, including education on surveillance care, reminders to complete care and assistance in scheduling surveillance, and access to the online CTAC intervention, which includes self-directed, interactive education about surveillance and a checklist of care, within 3 months of standard of care surgical resection. Receives: Other: Educational Intervention; Other: Electronic Health Record Review; Other: Internet-Based Intervention; Behavioral: Patient Navigation; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of colonoscopy (stage I colorectal carcinoma patients)
Measured: Up to 18 months post-surgical resection
Completing any colonoscopy, carcinoembryonic antigen tumor marker (CEA), and cross-sectional imaging (stage II-III colorectal carcinoma patients)
Will compare rates of surveillance care completion 1-year (up to 18 months accounting for delays that may be due to inability accessing endoscopy) post-surgical resection across groups using chi-square tests. Will use a multivariable logistic regression model to test for factors that may be associated with increased or decreased surveillance care including patient-level demographic factors (e.g., age, sex, etc.) and available clinic-level factors (e.g., clinic size, etc.).
Measured: Up to 18 months post-surgical resection
Secondary outcomes (5)
Knowledge of colorectal cancer (CRC) surveillance
Knowledge will be assessed using a previously validated 5-item scale. Responses will be graded on a scale of 0 to 5 with higher scores representing higher knowledge; scores can also be dichotomized into high and low knowledge.
Measured: At baseline and at 3 months post enrollment
Self-efficacy to complete CRC surveillance
Will be measured using 7-items on a 5-point Likert scale ("strongly disagree" to "strongly agree"). Responses will be averaged with higher scores indicating greater self-efficacy.
Measured: At baseline and at 3 months post enrollment
Acceptability of the intervention
Assessed using Acceptability of the Intervention Measure. Will calculate and compare mean scores between individual participants and exposure group using student's t-test.
Measured: At baseline and at 3 months post enrollment
Intervention appropriateness
Assessed using Intervention Appropriateness Measure (IAM). Will calculate and compare mean scores between individual participants and exposure group using student's t-test.
Measured: At baseline and at 3 months post enrollment
Feasibility of the intervention
Assessed using Feasibility of Intervention Measure (FIM) scores. Will calculate and compare mean scores between individual participants and exposure group using student's t-test.
Measured: At baseline and at 3 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start17 Nov 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage I Colorectal Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Rachel B. Issaka, MD, MAS, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995924
- Sponsor's protocol ID
- RG1125283
- Other IDs
- NCI-2025-03304, 20875, P30CA015704
- Status last verified
- Aug 2026
- First submitted
- 21 May 2025
- Last updated
- 1 Sep 2026
- 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 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial to Evaluate the Effectiveness of Navigation, Interactive Web Education, or the Combination of Both to Promote Guideline-Concordant Colorectal Cancer Surveillance Care
- ClinicalTrials.gov ID
- NCT06995924
- Acronym / sponsor ID
- RG1125283
- Conditions
- Stage I Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 30 May 2025 (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 pilot clinical trial looks at whether patient navigation services, an interactive web education intervention, called Current Together After Cancer (CTAC), or both navigation and CTAC works to improve the uptake of surveillance in patients with stage I-III colorectal cancer (CRC). Post-treatment surveillance is critical to detect recurrence early, yet many CRC survivors do not receive recommended surveillance care. Surveillance is a complex process that includes laboratory tests, cross-sectional imaging, and endoscopic procedures. Patient navigation services, interactive web education, or a combination of both may improve surveillance care for patients with stage I-III colorectal cancer.
Detailed description
OUTLINE:
Patients are assigned to 1 of 3 arms based on the clinic location they receive cancer care at.
ARM A: Patients receive access to navigation services, including education on surveillance care, reminders to complete care and assistance in scheduling surveillance, within 3 months of standard of care surgical resection for stage I-III CRC.
ARM B: Patients receive access to the CTAC intervention, which includes self-directed, interactive web-based education about surveillance and a checklist of care, within 3 months of standard of care surgical resection for stage I-III CRC.
ARM C: Patients receive access to navigation services, including education on surveillance care, reminders to complete care and assistance in scheduling surveillance, and access to the CTAC intervention, which includes self-directed, interactive web-based education about surveillance and a checklist of care, within 3 months of standard of care surgical resection for stage I-III CRC.
Patients are followed up at 3 months post study-enrollment and 12-18 months after surgical resection.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A (navigation) | Experimental | Other: Electronic Health Record Review, Behavioral: Patient Navigation, Other: Survey AdministrationPatients receive access to navigation services, in person, via telephone or via electronic conferencing platform, including education on surveillance care, reminders to complete care and assistance in scheduling surveillance, within 3 months of standard of care surgical resection. |
| Arm B (CTAC) | Experimental | Other: Educational Intervention, Other: Electronic Health Record Review, Other: Internet-Based Intervention, Other: Survey AdministrationPatients receive access to the online CTAC intervention, which includes self-directed, interactive education about surveillance and a checklist of care, within 3 months of standard of care surgical resection. |
| Arm C (navigation and CTAC) | Experimental | Other: Educational Intervention, Other: Electronic Health Record Review, Other: Internet-Based Intervention, Behavioral: Patient Navigation, Other: Survey AdministrationPatients receive access to navigation services, in person, via telephone or via electronic conferencing platform, including education on surveillance care, reminders to complete care and assistance in scheduling surveillance, and access to the online CTAC intervention, which includes self-directed, interactive education about surveillance and a checklist of care, within 3 months of standard of care surgical resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 due to disease and clinic population
- Stage I-III CRC survivor within 3 months post-surgical resection
- Being seen at a participating clinic
- Ability to understand and complete surveys in English
Key exclusion criteria (0 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 |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalComplete self-directed interactive education | Other | Arm B (CTAC), Arm C (navigation and CTAC) |
| Electronic Health Record ReviewAncillary studies | Other | Arm A (navigation), Arm B (CTAC), Arm C (navigation and CTAC) |
| Internet-Based InterventionReceive access to CTAC | Other | Arm B (CTAC), Arm C (navigation and CTAC) |
| Patient NavigationAlso: Patient Navigator ProgramReceive patient navigation services | Behavioural | Arm A (navigation), Arm C (navigation and CTAC) |
| Survey AdministrationAncillary studies | Other | Arm A (navigation), Arm B (CTAC), Arm C (navigation and CTAC) |
Primary outcome
Completion of colonoscopy (stage I colorectal carcinoma patients)
Time frame: Up to 18 months post-surgical resection
Completing any colonoscopy, carcinoembryonic antigen tumor marker (CEA), and cross-sectional imaging (stage II-III colorectal carcinoma patients)
Time frame: Up to 18 months post-surgical resection
Will compare rates of surveillance care completion 1-year (up to 18 months accounting for delays that may be due to inability accessing endoscopy) post-surgical resection across groups using chi-square tests. Will use a multivariable logistic regression model to test for factors that may be associated with increased or decreased surveillance care including patient-level demographic factors (e.g., age, sex, etc.) and available clinic-level factors (e.g., clinic size, etc.).
5 secondary outcomes
Knowledge of colorectal cancer (CRC) surveillance
Time frame: At baseline and at 3 months post enrollment
Self-efficacy to complete CRC surveillance
Time frame: At baseline and at 3 months post enrollment
Acceptability of the intervention
Time frame: At baseline and at 3 months post enrollment
Intervention appropriateness
Time frame: At baseline and at 3 months post enrollment
Feasibility of the intervention
Time frame: At baseline and at 3 months post enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- 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.
Rachel B. Issaka, MD, MAS principal investigator
Fred Hutch/University of Washington Cancer Consortium
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, Electronic Health Record Review and Internet-Based Intervention in people with Stage I Colorectal Cancer AJCC v8 and Stage II Colorectal Cancer AJCC v8, run by Fred Hutchinson Cancer Center 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 4 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 1 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ari Bell-Brown (206.667.7624, abellbro@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of colonoscopy (stage I colorectal carcinoma patients) (time frame: Up to 18 months post-surgical resection). The study lists 2 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 Sep 2026.