Recruiting

Legal Guidance and Advocacy for Caregivers of Colorectal Cancer Patients

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Study AimThis study aims to provide legal guidance and advocacy support to caregivers of colorectal cancer patients to help them navigate caregiving challenges.
What is being tested

Legal Services

Other
Who is being recruted

Caregiver Burden
+12

+ Behavior
+ Behavioral Symptoms
Over 18 Years
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorMasonic Cancer Center, University of Minnesota
Study ContactArjun Gupta, MBBS
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: September 9, 2025Actual date on which the first participant was enrolled.

This study aims to explore the benefits of offering free legal support to caregivers and patients dealing with colorectal cancer. Since managing this condition can be both financially and emotionally challenging, the trial investigates if early legal assistance can help improve the quality of life for those involved. The focus is on how these services can aid in easing financial stress and enhancing emotional well-being, addressing unmet needs in the caregiving experience. Participants in the study, which include both patients and their caregivers, will receive complimentary and personalized legal services provided by Cancer Legal Care, a nonprofit organization based in Minnesota. These services are intended to assist with any legal issues that might arise during the cancer treatment journey. The study lasts for three months, but participants are welcome to continue accessing legal support even after the study ends. This approach evaluates how feasible and acceptable it is to integrate legal care into the support system for those affected by colorectal cancer.

Official TitleLEgal Guidance and AdvocaCY for CAREgivers (LEGACY CARE): A Pilot Clinical Trial for Caregivers of Persons With Colorectal Cancer 
NCT07153016
Principal SponsorMasonic Cancer Center, University of Minnesota
Study ContactArjun Gupta, MBBS
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
20 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Caregiver Burden
Behavior
Behavioral Symptoms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Stress, Psychological
Colorectal Neoplasms
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
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.

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

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 Objectives

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Masonic Cancer CenterMinneapolis, United StatesSee the location
Recruiting
One Study Center
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