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Completed

NCT Number: NCT06475664

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. The Perceived Stress Scale 4 (PSS-4)

    Time frame: baseline, 3 months, 6 months

    A 4-item measure of perceived stress.

  2. 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.

  3. The COmprehensive Score for financial Toxicity (COST)

    Time frame: baseline, 3 months, 6 months

    A 12-item measure of financial toxicity.

  4. The National Comprehensive Cancer Network's (NCCN) Distress Thermometer

    Time frame: baseline, 3 months, 6 months

    A single-item measure of psychological distress.

  5. The Spitzer Uniscale (UNISCALE)

    Time frame: baseline, 3 months, 6 months

    A single-item measure of overall quality of life.

  6. 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).

  7. Pearlin Mastery Scale

    Time frame: baseline, 3 months, 6 months

    A 7-item measure of psychological coping

    (mastery).

  8. 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.

  9. Rosenberg Self-Esteem (RSE) Scale

    Time frame: baseline, 3 months, 6 months

    A 10-item measure of self-esteem.

  10. Cancer Related Behavior Questionnaire

    Time frame: baseline, 3 months, 6 months

    A 31-item measure of comfort facing cancer related issues.

  11. Cancer Legal Care Services Questionnaire

    Time frame: baseline, 3 months, 6 months

    A 13-item measure of CLC

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jun 26, 2024
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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