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

N/AActive Not RecruitingNCT07153016

Masonic Cancer Center, University of Minnesota20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Caregiver Burden Colorectal Cancer Legal Intervention

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Secondary Outcomes

Acceptability

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.