Improving Uptake of Surveillance in Colorectal Cancer Survivors Through Navigation and Web Education

Not Applicable

Not yet recruiting

• Conditions: Stage I Colorectal Cancer AJCC v8; Stage II Colorectal Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8

• Registration Number: NCT06995924
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief 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). 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 and 9 months post study-enrollment and 12-18 months after surgical resection.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-21
• Study First Submitted QC: 2025-05-21
• Study First Posted: 2025-05-30
• Last Update Submitted: 2025-06-03
• Last Update Posted: 2025-06-05
• Study Start: 2025-07-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Completing any colonoscopy, carcinoembryonic antigen tumor marker (CEA), and cross-sectional imaging	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.).

Secondary Outcome Measures

Name	Time	Method
Knowledge of colorectal cancer (CRC) surveillance	At baseline, 3 and 9 months post enrollment	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.
Self-efficacy to complete CRC surveillance	At baseline, 3 and 9 months post enrollment	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.
Acceptability of the intervention	At 3 and 9 months post enrollment	Assessed using Acceptability of the Intervention Measure. Will calculate and compare mean scores between individual participants and exposure group using student's t-test.
Intervention appropriateness	At 3 and 9 months post enrollment	Assessed using Intervention Appropriateness Measure (IAM). Will calculate and compare mean scores between individual participants and exposure group using student's t-test.
Feasibility of the intervention	At 3 and 9 months post enrollment	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.

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States