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CompletedNCT06475664Updated Feb 12, 2026

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

An Early Phase 1 interventional study of Personalized legal care services in Colorectal Cancer, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-12.

Sponsored by University of Minnesota · Early Phase 1, Interventional, and Other

Phase
Early Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Colorectal Cancer
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In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 20 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

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

Phase
Early Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Experimental group

    adult patients with advanced colorectal cancel

    Other: Personalized legal care services

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.

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What researchers measure

Primary outcomes

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

    A 4-item measure of perceived stress.

    Time frame: baseline, 3 months, 6 months

  2. The Cancer Behavior Inventory-Brief Version (CBI-B)

    A 12-item measure of self-efficacy coping with cancer.

    Time frame: baseline, 3 months, 6 months

  3. The COmprehensive Score for financial Toxicity (COST)

    A 12-item measure of financial toxicity.

    Time frame: baseline, 3 months, 6 months

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

    A single-item measure of psychological distress.

    Time frame: baseline, 3 months, 6 months

  5. The Spitzer Uniscale (UNISCALE)

    A single-item measure of overall quality of life.

    Time frame: baseline, 3 months, 6 months

  6. 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).

    Time frame: baseline, 3 months, 6 months

  7. Pearlin Mastery Scale

    A 7-item measure of psychological coping (mastery).

    Time frame: baseline, 3 months, 6 months

  8. 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.

    Time frame: baseline, 3 months, 6 months

  9. Rosenberg Self-Esteem (RSE) Scale

    A 10-item measure of self-esteem.

    Time frame: baseline, 3 months, 6 months

  10. Cancer Related Behavior Questionnaire

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

    Time frame: baseline, 3 months, 6 months

  11. Cancer Legal Care Services Questionnaire

    A 13-item measure of CLC

    Time frame: baseline, 3 months, 6 months

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Study locations

1 site
  • University of Minnesota
    Minneapolis, Minnesota 55414, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06475664
Lead sponsor
University of Minnesota
Responsible party
Sponsor
First posted
Jun 26, 2024
Start date
Aug 1, 2024
Primary completion
Oct 18, 2024
Completion
Jun 5, 2025
Last update
Feb 12, 2026

Study contacts

Arjun Gupta, MD
principal investigator · University of Minnesota

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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