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

Early Phase 1

Active, not recruiting

• Conditions: Colorectal Cancer
• Interventions: Other: Personalized legal care services

• Registration Number: NCT06475664
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-18
• Study First Submitted QC: 2024-06-20
• Study First Posted: 2024-06-26
• Study Start: 2024-08-01
• Primary Completion: 2024-10-18
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-05
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	Personalized legal care services	adult patients with advanced colorectal cancel

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States