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NCT Number: NCT07153016

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

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.

Recruiting

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Key information

Conditions

Caregiver Burden Behavior Behavioral Symptoms Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Legal Intervention Neoplasms Neoplasms by Site Rectal Diseases Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Arjun Gupta, MD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Legal Services

Other

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

Primary outcomes

  1. Feasibility

    Time frame: 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 outcomes

  1. Acceptability

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Arjun Gupta, MBBS

CONTACT

[email protected]

612-626-5906

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 3, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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