Stage I Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8
Conditions
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 months post study-enrollment and 12-18 months after surgical resection.
Interventions
OTHEREducational Intervention
Complete self-directed interactive education
OTHERElectronic Health Record Review
Ancillary studies
OTHERInternet-Based Intervention
Receive access to CTAC
BEHAVIORALPatient Navigation
Receive patient navigation services
OTHERSurvey Administration
Ancillary studies
Sponsors
Fred Hutchinson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Knowledge of colorectal cancer (CRC) surveillance | At baseline and at 3 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 and at 3 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 baseline and at 3 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 baseline and at 3 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 baseline and at 3 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. |
Countries
United States
Contacts
CONTACTAri Bell-Brown
PRINCIPAL_INVESTIGATORRachel B. Issaka, MD, MAS
Fred Hutch/University of Washington Cancer Consortium
Outcome results
None listed