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LEgal Guidance and AdvocaCY for CAREgivers (LEGACY CARE): A Pilot Clinical Trial for Caregivers of Persons With Colorectal Cancer

LEgal Guidance and AdvocaCY for CAREgivers (LEGACY CARE): A Pilot Clinical Trial for Caregivers of Persons With Colorectal Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07153016
Enrollment
20
Registered
2025-09-03
Start date
2025-09-09
Completion date
2027-12-31
Last updated
2026-09-17

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

Conditions

Caregiver Burden, Colorectal Cancer, Legal Intervention

Brief summary

This is a single center single-arm, pilot study of proactive and early connection with free legal care services for patient-caregiver dyads affected by colorectal cancer to assess the feasibility, acceptability, and preliminary efficacy of this intervention in improving financial and psychosocial outcomes. Participants (i.e. patient-caregiver dyads) 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 3 months, however, participants may continue to access free personalized legal care services beyond this period.

Interventions

OTHERLegal Services

Legal care services from Cancer Legal Care (CLC), a nonprofit organization located in the Twin Cities of Minnesota.

Sponsors

Masonic Cancer Center, University of Minnesota
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

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

Inclusion criteria

Colorectal Cancer Patient Inclusion Criteria: * Diagnosis of advanced stage (Stage III or Stage IV) colorectal cancer within the past 3 months. * Initiated or planning to initiate systemic cancer therapy. * Able to identify a caregiver for study participation. * 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. Caregiver Inclusion Criteria: * 18 years of age or older at the time of consent. * Identified as a caregiver by a colorectal cancer patient. * 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/diminished capacity to consent.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility3 monthsFeasibility will be measured through rates of 1) initial engagement (i.e., percent of patients and caregivers who meet with a CLC representative), 2) continued engagement (i.e., percentage of patients and caregivers who respond to questionnaires at months 3), and 3) intervention completion (i.e., percentage of patients and caregivers who receive a legal service). The mean of the 3 metrics will be used to determine feasibility. The intervention will be deemed as feasible if ≥50% is met on each of the 3 feasibility metrics.

Secondary

MeasureTime frameDescription
Acceptability3 monthsAcceptability will be assessed through experiences from patients and caregivers. At the end of the 3-months, we will ask all participants how likely they are to recommend this intervention to other patients and/or caregivers (a 5-point Likert scale of likeliness to recommend, ranges from 1-5). 1 meaning the least likely and 5 meaning the most likely to recommend this intervention.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026