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

February 10, 2026 updated by: University of Minnesota
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: baseline, 3 months, 6 months
A 4-item measure of perceived stress.
baseline, 3 months, 6 months
The Cancer Behavior Inventory-Brief Version (CBI-B)
Time Frame: baseline, 3 months, 6 months
A 12-item measure of self-efficacy coping with cancer.
baseline, 3 months, 6 months
The COmprehensive Score for financial Toxicity (COST)
Time Frame: baseline, 3 months, 6 months
A 12-item measure of financial toxicity.
baseline, 3 months, 6 months
The National Comprehensive Cancer Network's (NCCN) Distress Thermometer
Time Frame: baseline, 3 months, 6 months
A single-item measure of psychological distress.
baseline, 3 months, 6 months
The Spitzer Uniscale (UNISCALE)
Time Frame: baseline, 3 months, 6 months
A single-item measure of overall quality of life.
baseline, 3 months, 6 months
Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I)
Time Frame: baseline, 3 months, 6 months
A 9-item measure of perceptions of interpersonal relationships with a patient navigator (i.e. CLC).
baseline, 3 months, 6 months
Pearlin Mastery Scale
Time Frame: baseline, 3 months, 6 months

A 7-item measure of psychological coping

(mastery).
baseline, 3 months, 6 months
The Life Engagement Test (LET)
Time Frame: baseline, 3 months, 6 months
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
Time Frame: baseline, 3 months, 6 months
A 10-item measure of self-esteem.
baseline, 3 months, 6 months
Cancer Related Behavior Questionnaire
Time Frame: baseline, 3 months, 6 months
A 31-item measure of comfort facing cancer related issues.
baseline, 3 months, 6 months
Cancer Legal Care Services Questionnaire
Time Frame: baseline, 3 months, 6 months
A 13-item measure of CLC
baseline, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe