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

NCT06475664 | Completed Early Phase 1

• 1 other identifier: 2023LS176
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (1)

Experimental group

EXPERIMENTAL

adult patients with advanced colorectal cancel

Other: Personalized legal care services

Interventions

Personalized legal care services OTHER

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.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of advanced stage colorectal cancer.
• Estimated life expectancy of over 6 months in the opinion of the treating oncologist.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Arjun Gupta, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single center single-arm, pilot study

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 26, 2024
• Study Start: August 1, 2024
• Primary Completion: October 18, 2024
• Study Completion: June 5, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

US (1)