Colorectal Cancer Legal and Administrative Burden Support: A Pilot Clinical Trial

This is a single center single-arm, pilot study of proactive and early connection with free legal care services for persons with advanced colorectal cancer to assess the feasibility, acceptability, and preliminary efficacy of this intervention in improving financial and psychosocial outcomes. Participants will receive free, personalized legal care services from Cancer Legal Care (CLC), a nonprofit organization located in the Twin Cities of Minnesota. The duration of study participation is 6 months, however, participants may continue to access free personalized legal care services beyond this period. All participants continue to receive standard of care as prescribed by their treating physician.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Personalized legal care services

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of advanced stage colorectal cancer.
• Estimated life expectancy of over 6 months in the opinion of the treating oncologist.
• 18 years of age or older at the time of consent.
• Able to understand, speak, read, and write in English.
• Able to provide voluntary written consent prior to the performance of any research related activity.

Exclusion Criteria:

• Lacks capacity to consent/has diminished capacity to consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; adult patients with advanced colorectal cancel	Other: Personalized legal care services; Participants will receive free, personalized legal care services from Cancer Legal Care (CLC), a nonprofit organization located in the Twin Cities of Minnesota. The duration of study participation is 6 months, however, participants may continue to access free personalized legal care services beyond this period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Perceived Stress Scale 4 (PSS-4)	A 4-item measure of perceived stress.	baseline, 3 months, 6 months
The Cancer Behavior Inventory-Brief Version (CBI-B)	A 12-item measure of self-efficacy coping with cancer.	baseline, 3 months, 6 months
The COmprehensive Score for financial Toxicity (COST)	A 12-item measure of financial toxicity.	baseline, 3 months, 6 months
The National Comprehensive Cancer Network's (NCCN) Distress Thermometer	A single-item measure of psychological distress.	baseline, 3 months, 6 months
The Spitzer Uniscale (UNISCALE)	A single-item measure of overall quality of life.	baseline, 3 months, 6 months
Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I)	A 9-item measure of perceptions of interpersonal relationships with a patient navigator (i.e. CLC).	baseline, 3 months, 6 months
Pearlin Mastery Scale	A 7-item measure of psychological coping (mastery).	baseline, 3 months, 6 months
The Life Engagement Test (LET)	A 6-item measure of purpose in life, defined as the extent to which a person engages in activities that are personally meaningful.	baseline, 3 months, 6 months
Rosenberg Self-Esteem (RSE) Scale	A 10-item measure of self-esteem.	baseline, 3 months, 6 months
Cancer Related Behavior Questionnaire	A 31-item measure of comfort facing cancer related issues.	baseline, 3 months, 6 months
Cancer Legal Care Services Questionnaire	A 13-item measure of CLC	baseline, 3 months, 6 months

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Arjun Gupta, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): October 18, 2024
• Study Completion (Actual): June 5, 2025

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: June 20, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2023LS176

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No