Risk Stratified Survivorship Care Pathways For Early-Onset Colorectal Cancer

The overall goal of the proposed study is to develop stratified survivorship care pathways for patients with early-onset colorectal cancer (CRC). The Kentucky Cancer Registry (KCR) will participate in early-onset CRC patient identification, cancer recurrence identification, and survey recruitment activities for Aims 1 and 2. The study involves application of a new methodology and identification of patterns of recurrences by combining archival registry, mortality, and electronic pathology report data. We will then assess via survey patients’ receipt of surveillance and survivorship care needs among a diverse cohort of patients with early onset CRC. This will be the first study to describe patterns of recurrence and survivorship care needs among this rapidly-growing population of younger cancer survivors and the goal is to impact the quality and value of survivorship care for this population. Aim 1 Approach The proposed study is a population-based, mixed-methods study of adults with early-onset CRC. Aim 1 takes place during Years 1-2 of the proposed study. In Aim 1, the KCR will use routine case ascertainment to identify all adult patients 18-50 years of age with incident Stages I-III CRC in diagnosis years 2015-2018 as reported to the Kentucky SEER registry (n =1022). KCR staff will abstract key clinical cancer and demographic variables and employ a multi-pronged methodology to identify recurrences in the 5-year period following initial diagnosis, including data from the following sources: 1) SEER pathology and available pathology reports a. We will abstract both electronic and hard copy (as needed) reports for all pathology reports identified over the 5-year post-diagnosis period and manually review them for evidence of recurrence. We estimate about 95% of e-path coverage for CRC cases. In an on-going study with SEER and Department of Energy (DoE), a cancer recurrence identification algorithm is being developed and validated using e-path reports. We expect to utilize the algorithm and perform manual review to identify cancer recurrence for this study. 2) Commission on Cancer (CoC) hospital recurrence data a. We will utilize the CoC-Kentucky SEER data linkage to identify any additional recurrences not captured via pathology reports 3) SEER mortality data a. We will use linked data from state vital records and National Death Index Files to identify any patients who later died from CRC. These patients will be considered to have experienced recurrence or progression to metastatic disease. Depending on needs and data availability, we potentially can use Medicaid and Medicare claims data for any additional cases not captured in the steps described above. Aim 2 Approach Patient Eligibility and Recruitment For Aim 2, the KCR will identify and accrue via rapid case ascertainment a sample of 1000 all potential adults aged 18-50 years who were diagnosed with incident Stages I-III CRC in diagnosis years 2019-2023. African American, Asian, and Latina patients, and patients with stage III disease will be oversampled. Accrued patients will be recruited into a survey study to assess patient-reported receipt of surveillance care and survivorship care needs. Patient recruitment is expected to take place over an 18-month period spanning from November 2023 through April 2025 (Years 2-3). Survey mailouts will be divided evenly over the first 12 months of the recruitment period. We will conduct 12 mailouts of 83 patients each and continue follow-up for six additional months. Projecting a response rate of 55% based on our prior work in colorectal cancer survivors, we expect a final analytic sample from Kentucky of approximately 550 patients completing the survey. The study is being conducted in conjunction with the University of Michigan (UM), the University of Southern California (USC), and the University of Georgia (UG). Drs. Wallner and Suwanabol are Co-PIs at UM and Dr. Huang is the subcontract PI at University of Kentucky (UK). A more detailed recruitment protocol is provided below. Recruitment Protocol 1. Beginning in November 2024, we will identify 83 eligible early-onset CRC patients from the Kentucky Cancer registry. 11 additional equivalent data pulls of 83 cases will be made over the subsequent 11 months. 6 additional months of follow-up will complete the 18 month recruitment period for the study subjects. 2. With each monthly data pull from the registry, tracing services will be utilized to locate current mailing addresses and phone numbers for the selected cases. Lexus Nexus linkage will be performed to identify most current contact information. 3. Cases will be entered into a tracking database to monitor recruitment progress throughout all phases. 4. Patient physician will be contacted first by postcard. Then study packets, including an introductory letter, research information sheet, survey, and a $20 incentive, will be mailed to selected subjects each month. A pre-paid return envelope will be included to mail the completed survey back to the KCR. A toll-free telephone number will be provided in the invitation materials to enable individuals to ask questions about the study. 5. If mail is returned undeliverable, an attempt will be made to obtain an alternate mailing address and step 4 will be repeated. 6. We will employ a modified version of the Dillman method to encourage response in this population. Two to three weeks after the initial survey mailing, KCR field staff will call individuals who have not returned a completed survey. The purpose of the call is to clarify questions, explain confidentiality procedures, and encourage participation. Individuals wishing to complete the survey by phone will be allowed to do so. 7. Individuals who cannot be contacted by phone will receive a post-card reminder to please consider participation in the study or to call with any questions about the study. 8. Two weeks after a successful telephone contact, a reminder postcard will be mailed encouraging the return of the completed survey. 9. For those who remain non-responders after two additional weeks, a second recruitment package will be mailed with an online survey option included. If the survey has still not been returned within three weeks, an additional follow-up phone call will be made to the non-responders. 10. As surveys are returned, survey quality will be examined quickly. To address missing data or invalid responses, we will deploy a procedure that we have used with great success. Specifically, if items appear to be inadvertently missed (as opposed to intentionally skipped) we will call back patients whose returned surveys have omitted key information or invalid responses. If we are unable to reach respondents by phone we will mail: a copy of the pages with the missing items highlighted, a letter requesting that the respondent complete these items, and a stamped, addressed return envelope. 11. Returned surveys will be scanned and then the scanned version will be cleaned of all identifying information except a unique identification number. Original surveys will be stored in secured file cabinets. Information from the surveys on the clinicians of the patients will be entered in the tracking database. 12. De-identified scanned copies of the surveys will be securely transmitted to UM using FES, a secure file transfer server at the KCR. All surveys will be encrypted prior to transmission. All research procedures will be submitted for approval to GA DPH IRBs upon notification of funding. The study will utilize a single institutional IRB of record (Michigan) for compliance with NIH policies