Legal Evaluation for Greater Access to Cancer Care (LEGAL-CARE)

NCT07197515 | Recruiting

• 2 other identifiers: 300014052UAB O'Neal Invest Award
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to help patients with cancer facing legal issues. The investigators noticed that many patients struggle with laws and regulations related to disability benefits, employment rules, health insurance denials, and financial assistance barriers among many others. To understand this better, the investigators conducted the first nationwide study on how legal problems affect patients with cancer. Investigators noted a striking prevalence of legal issues in patients with cancer - most struggled with 2 or more legal issues that impacted their care. These legal issues looked different for those with different socioeconomic backgrounds. In a second study, the investigators also found healthcare workers (HCWs) including social workers and navigators feel underprepared to counsel patients on legal topics. Now, the investigators launching a pilot program called LEGAL-CARE at the O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham (UAB) to help patients navigate these legal hurdles. Patients in the study will receive legal navigation, where they will get help with legal issues related to their cancer treatment. The investigators will look at how practical or feasible such a program is, and how it affects patients' lives over time. The investigators will check in with the participants at regular time intervals to see if they feel less stressed about money, have a better quality of life, and use healthcare services differently. The investigators will also see if the program helps reduce the number of legal problems they face. Finally, the investigators will discuss with the participants about how this legal intervention could be made better. This study is important because it's the first of its kind. It will give insights into how legal problems impact patients with cancer and how addressing these issues can improve their lives. Plus, it'll help the investigators better understand implementing similar programs in other places. Overall, it's a partnership between O'Neal, national legal assistance organizations, and the Birmingham community to make life easier for people dealing with cancer and legal challenges. Ultimately, the goal will be to take what the investigators learn here to run a larger multi-site trial.

Conditions

Cancer

Keywords

legal; navigation; legal barriers; cancer; oncology

Outcome Measures

Primary Outcomes (1)

• Feasibility Benchmarks

  Feasibility will be measured by 1. retention of ≥70% of enrolled patients at 6 months and 2. ≥75% completion of biweekly surveys among retained patients. Acceptability will be measured by the Acceptability of Intervention Measure (AIM), 4 items on a 5-point Likert scale (1-5; higher = more acceptable). Appropriateness will be measured by the Intervention Appropriateness Measure (IAM), 4 items on a 5-point Likert scale (1-5; higher = more appropriate). Feasibility (perceptions) will be measured by the Feasibility of Intervention Measure (FIM), 4 items on a 5-point Likert scale (1-5; higher = more feasible).

  6 months

Secondary Outcomes (2)

• Patient perceptions of legal intervention impact

  At the end of 6 month legal intervention

• Financial hardship, health-related quality of life, legal burden, administrative burden, and health care utilization

  6 months

Study Arms (1)

Legal Intervention Arm

EXPERIMENTAL

There will be 6 proactive legal intervention cycles. During each, an attorney will proactively reach out to the patient or caregiver via telephone or video call within the first month of enrollment to identify and address legal barriers in areas such as health insurance, financial, disability insurance, employment, and other (estate planning, advanced directives, life insurance, family law). The attorney will guide patients and caregivers through necessary actions, and provide resolution. Baseline, 3, and 6 months surveys will be collected, as well as additional surveys at the 1, 2, 3, 4, 5, and 6 month check ins with the legal team.

Behavioral: Legal Navigation

Interventions

Legal Navigation BEHAVIORAL

• Participants will receive monthly outreach from a trained legal navigator over a 6-month period. The legal navigator is a lawyer (Juris Doctor, or JD) who will proactively address specific legal barriers the patient may encounter during treatment. Communication will include phone calls (and if requested, virtual consultations) tailored to patient needs. In between legal outreach periods, patients may call the legal navigator team themselves for legal needs that may arise.

Also known as: Navigation

Legal Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• New de novo advanced stage cancer (stages III/IV) requiring systemic therapy..

You may not qualify if:

• non-melanoma skin cancer
• benign cancer or in-situ tumor
• a recurrence of a previously diagnosed cancer
• a hospice encounter in the past year
• those unable to complete surveys
• unable to communicate fluently in English
• unable to provide consent in English

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Triage Cancer: collaborator

Study Sites (1)

The Kirklin Clinic

Birmingham, Alabama, 35233, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Qasim M Hussaini, MD, MS

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stacey A Ingram, MEd, CHES

CONTACT

205-934-5287; saadewakun@uabmc.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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 29, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

US (1)