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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06475664
Enrollment
20
Registered
2024-06-26
Start date
2024-08-01
Completion date
2025-06-05
Last updated
2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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.

Interventions

OTHERPersonalized 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.

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

This is a single center single-arm, pilot study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORArjun Gupta, MD

University of Minnesota

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026