Colorectal cancer legal and administrative burden support (COLLABS): A pilot clinical trial.
Authors: Phung Quan , Pecoraro Alyssa , Wesley Erin , Jansen Rick , Yokanovich Lindy , Kourelis Rachel , Hartung Erin , Blaes Anne Hudson , Vogel Rachel I. , Parsons Helen M. , Gupta Arjun 
Published: January 2025

TPS307

Background:
Patients with colorectal cancer often have health-related social needs (e.g. food insecurity, housing instability, employment loss). Failure to adequately address these is associated with financial hardship, worse quality-of-life, psychosocial distress, lower rates of treatment receipt, and worse survival. Cancer clinical care teams often lack the resources, knowledge, and processes to resolve these issues, many of which are actually legal in nature. Engagement with legal teams—medical-legal partnerships—can screen for, prevent, and resolve health-related social needs, as well as address related legal issues such as insurance denials, employment rights and protections, disability benefits, debt management, and estate planning. Cancer Legal Care (CLC) is a nonprofit providing free legal services to persons affected by cancer in MN. Past CLC clients have indicated a preference for proactive connection to CLC to prevent crises and overcome barriers to access such as concerns regarding perceived costs of legal services.
Methods:
This is a single-arm, pilot study to evaluate the feasibility, acceptability, and preliminary efficacy of proactive and free legal care support for patients with colorectal cancer at the University of Minnesota. The enrollment goal is 20 patients and the trial duration is 6 months. Inclusion criteria include English-speaking adults with advanced stage colorectal cancer and estimated life expectancy of >6 months. There is no requirement for baseline health-related social need(s) or time from diagnosis. After participants complete baseline surveys, we will connect them to a CLC attorney for an initial “legal care checkup”— the timing and method of connection (in-person, video visit, or phone call) is based on patient preference. Patients can bring up self-identified or active issues themselves, while CLC will also screen for needs. CLC will provide any required legal services and engage with the cancer care team as needed. CLC will follow-up with participants at 3 and 6 months, though services may continue after the study period off trial. Participants will complete surveys at baseline, 3 months, and 6 months. Surveys will assess patient-reported outcomes on financial toxicity, quality-of-life, comfort levels with accessing cancer care, status of health-related social and legal needs, perceived stress, life mastery and engagement, relationship with CLC contact, and acceptability of the intervention. The primary outcomes are feasibility (rates of initial engagement, continued engagement, and intervention completion; feasible if >50% on each metric) and acceptability. We will conduct exit qualitative interviews. We will collect sociodemographics, rates of treatment adherence/ completion, legal services provided, outcome of legal issues, and monetary savings or recovery for patients. Enrollment opened August 2024 and we have enrolled 15/20 participants.
Clinical trial information: NCT06475664
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