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

Not Applicable

Recruiting

• Conditions: Caregiver Burden; Colorectal Cancer; Legal Intervention

• Registration Number: NCT07153016
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-08-26
• Study First Submitted QC: 2025-08-26
• Status Verified: 2025-09
• Study First Posted: 2025-09-03
• Study Start: 2025-09-09
• Last Update Submitted: 2025-09-10
• Last Update Posted: 2025-09-16
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility	3 months	Feasibility 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 Outcome Measures

Name	Time	Method
Acceptability	3 months	Acceptability 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.

Trial Locations

Locations (1)

Masonic Cancer Center; 🇺🇸 Minneapolis, Minnesota, United States