Legal Guidance and Advocacy for Caregivers (LEGACY CARE): A pilot clinical trial for patients with colorectal cancer and their caregivers.

Abstract

TPS249 Background: Patients with colorectal cancer and their caregivers often face financial, legal, and administrative burdens, including employment disruption, transferred medical debt, and difficulty navigating benefits. Well-intentioned cancer care teams often lack the expertise and resources to address these issues, many of which have legal underpinnings ("health harming legal needs"). Medical-legal partnerships can proactively identify, prevent, and resolve such needs, including insurance denials, employment rights, and estate planning. Cancer Legal Care (CLC) is a Minnesota-based nonprofit providing free legal services to persons affected by cancer. In a prior pilot trial focused on patients, a proactive legal support intervention was feasible, acceptable, and associated with increased comfort with health access/affordability. A key insight from patients was that many issues were shared or intertwined with caregivers, highlighting the need to consider patient-caregiver dyads. Methods: This is a single-arm, pilot study evaluating the feasibility and acceptability of proactive and free legal support, and the preliminary efficacy in addressing health harming legal needs, for patient-caregiver dyads at the University of Minnesota. The enrollment goal is 10 dyads (20 individuals) with a trial duration of 3 months. Eligible patients are English-speaking adults with recently diagnosed (<3 months) advanced stage colorectal cancer initiating or planning to initiate systemic cancer-directed therapy; patients will identify a single primary caregiver. If a participant would like >1 caregiver included, additional caregiver(s) will be supported off-study. Caregivers are English-speaking adults designated by the patient. After baseline surveys, dyads are connected to a CLC attorney for an initial “legal care checkup,” conducted in-person or virtually per participant preference. Participants can raise self-identified issues, while CLC also screens for needs. CLC will provide tailored legal services, and coordinate with the oncology team as needed. Follow-up with CLC is individualized, though services may continue off-trial after 3 months. Participants will complete baseline and 3-month surveys assessing financial toxicity, quality-of-life, comfort with accessing cancer care, status of health harming legal needs, and acceptability. We will conduct semi-structured exit interviews. The primary outcomes are feasibility (initial engagement, continued engagement, and intervention completion; feasible if ≥50% on each) and acceptability (≥50% of participants likely to recommend intervention to others). Secondary measures include descriptive analyses of participant-reported outcomes, the nature and resolution of legal issues, and thematic findings from exit interviews. Enrollment opened in September 2025. Clinical trial information: NCT07153016 .