Colorectal CancerEarly Phase 1NCT06475664
Colorectal Cancer Legal and Administrative Burden Support: A Pilot Clinical Trial
A Early Phase 1 study testing Personalized legal care services in people with Colorectal Cancer, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Personalized legal care services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 5 Jun 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Lacks capacity to consent/has diminished capacity to consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
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
- Being tested
- Personalized legal care services
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized legal care servicesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | adult patients with advanced colorectal cancel Receives: Other: Personalized legal care services |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Perceived Stress Scale 4 (PSS-4)
A 4-item measure of perceived stress.
Measured: baseline, 3 months, 6 months
The Cancer Behavior Inventory-Brief Version (CBI-B)
A 12-item measure of self-efficacy coping with cancer.
Measured: baseline, 3 months, 6 months
The COmprehensive Score for financial Toxicity (COST)
A 12-item measure of financial toxicity.
Measured: baseline, 3 months, 6 months
The National Comprehensive Cancer Network's (NCCN) Distress Thermometer
A single-item measure of psychological distress.
Measured: baseline, 3 months, 6 months
The Spitzer Uniscale (UNISCALE)
A single-item measure of overall quality of life.
Measured: 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).
Measured: baseline, 3 months, 6 months
Pearlin Mastery Scale
A 7-item measure of psychological coping
(mastery).
Measured: 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.
Measured: baseline, 3 months, 6 months
Rosenberg Self-Esteem (RSE) Scale
A 10-item measure of self-esteem.
Measured: baseline, 3 months, 6 months
Cancer Related Behavior Questionnaire
A 31-item measure of comfort facing cancer related issues.
Measured: baseline, 3 months, 6 months
Cancer Legal Care Services Questionnaire
A 13-item measure of CLC
Measured: baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 Aug 2024
- Primary completion18 Oct 2024
- Study completion5 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single center single-arm, pilot study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arjun Gupta, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475664
- Sponsor's protocol ID
- 2023LS176
- Status last verified
- Feb 2026
- First submitted
- 18 Jun 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Cancer Legal and Administrative Burden Support: A Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT06475664
- Acronym / sponsor ID
- 2023LS176
- Conditions
- Colorectal Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 18 Oct 2024 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single center single-arm, pilot study
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Personalized legal care servicesadult patients with advanced colorectal cancel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Lacks capacity to consent/has diminished capacity to consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized legal care servicesParticipants 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. | Other | Experimental group |
Primary outcome
The Perceived Stress Scale 4 (PSS-4)
Time frame: baseline, 3 months, 6 months
A 4-item measure of perceived stress.
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.
The COmprehensive Score for financial Toxicity (COST)
Time frame: baseline, 3 months, 6 months
A 12-item measure of financial toxicity.
The National Comprehensive Cancer Network's (NCCN) Distress Thermometer
Time frame: baseline, 3 months, 6 months
A single-item measure of psychological distress.
The Spitzer Uniscale (UNISCALE)
Time frame: baseline, 3 months, 6 months
A single-item measure of overall quality of life.
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).
Pearlin Mastery Scale
Time frame: baseline, 3 months, 6 months
A 7-item measure of psychological coping (mastery).
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.
Rosenberg Self-Esteem (RSE) Scale
Time frame: baseline, 3 months, 6 months
A 10-item measure of self-esteem.
Cancer Related Behavior Questionnaire
Time frame: baseline, 3 months, 6 months
A 31-item measure of comfort facing cancer related issues.
Cancer Legal Care Services Questionnaire
Time frame: baseline, 3 months, 6 months
A 13-item measure of CLC
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arjun Gupta, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Personalized legal care services in people with Colorectal Cancer, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Perceived Stress Scale 4 (PSS-4) (time frame: baseline, 3 months, 6 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.