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

NCT07153016 | Recruiting DMC

• 1 other identifier: 2025LS070
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver Burden; Colorectal Cancer; Legal Intervention

Outcome Measures

Primary Outcomes (1)

• Feasibility

  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.

  3 months

Secondary Outcomes (1)

• Acceptability

  3 months

Study Arms (1)

Patient - Caregiver Dyads

EXPERIMENTAL

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.

Other: Legal Services

Interventions

Legal Services OTHER

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

Patient - Caregiver Dyads

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• Lacks capacity to consent/diminished capacity to consent.

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Caregiver Burden; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Arjun Gupta, MBBS

CONTACT

612-626-5906; arjgupta@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

US (1)