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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-03304 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 20875 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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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.
OUTLINE:
Patients are assigned to 1 of 3 arms based on the clinic location they receive cancer care at.
ARM A (VIRGINIA MASON): 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 (FRED HUTCH [SOUTH LAKE UNION]): 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 (FRED HUTCH [OVERLAKE + EVERGREEN]): 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (navigation) | Experimental | Patients at the Virginia Mason clinic location 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. |
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| Arm B (CTAC) | Experimental | Patients at the Fred Hutch (South Lake Union) clinic location 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 | Patients at the Fred Hutch (Overlake + Evergreen) clinic location 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Complete self-directed interactive education |
|
| Measure | Description | Time Frame |
|---|---|---|
| Completion of colonoscopy (stage I colorectal carcinoma patients) | 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.). | Up to 18 months post-surgical resection |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline, and 3 months post enrollment |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ari Bell-Brown | Contact | 206.667.7624 | abellbro@fredhutch.org |
| Name | Affiliation | Role |
|---|---|---|
| Rachel B. Issaka, MD, MAS | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benaroya Research Institute at Virginia Mason | Recruiting | Seattle | Washington | 98101 | United States |
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| Electronic Health Record Review | Other | Ancillary studies |
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| Internet-Based Intervention | Other | Receive access to CTAC |
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| Patient Navigation | Behavioral | Receive patient navigation services |
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| Survey Administration | Other | Ancillary studies |
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| 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. |
| At baseline, and 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. | 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. | 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. | At 3 months post enrollment |
| Fred Hutch/University of Washington Cancer Consortium | Recruiting | Seattle | Washington | 98109 | United States |
|
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D062526 | Patient Navigation |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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