LEGAL-CARE: legal navigation to improve access to cancer care
Legal Evaluation for Greater Access to Cancer Care (LEGAL-CARE): A Pilot Feasibility Trial of a Legal Navigation Program to Address Cancer-related Legal Barriers
This pilot tests a legal navigation program to help adults newly diagnosed with advanced (stage III/IV) cancer overcome legal, insurance, and financial barriers during their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT07197515 on ClinicalTrials.gov |
What this trial studies
LEGAL-CARE is a pilot feasibility trial at the O'Neal Comprehensive Cancer Center offering a legal navigator to a small cohort of adult patients with a new de novo diagnosis of stage III or IV cancer who require systemic therapy. Participants will be offered at least one cycle of proactive legal intervention over a six-month period, in which a legal navigator reaches out to identify and address legal hardships related to disability, employment, insurance denials, and financial assistance. The study will collect feasibility metrics and use semi-structured interviews to characterize patient perceptions and experiences. The trial is clinic-based and designed to inform larger implementation studies and program expansion if feasible.
Who should consider this trial
Good fit: Adults aged 18 or older with a new de novo diagnosis of advanced (stage III or IV) cancer requiring systemic therapy who can communicate and consent in English and receive care at the UAB oncology clinic.
Not a fit: Patients with non-melanoma skin cancer, benign or in-situ tumors, recurrent cancer, a hospice encounter in the past year, those unable to complete surveys, or non-English speakers are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could reduce legal and administrative barriers to timely treatment, speed access to benefits and supports, and lessen financial and psychosocial strain for patients.
How similar studies have performed: The investigators' prior nationwide work documented widespread legal barriers for patients with cancer and social-legal partnership models have shown promise elsewhere, but this specific oncology legal-navigation pilot is a novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inclusion criteria includes adults ≥18 years old * New de novo advanced stage cancer (stages III/IV) requiring systemic therapy.. Exclusion Criteria: * 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
Where this trial is running
Birmingham, Alabama
- The Kirklin Clinic — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Qasim M Hussaini, MD, MS — University of Alabama at Birmingham
- Study coordinator: Stacey A Ingram, MEd, CHES
- Email: saadewakun@uabmc.edu
- Phone: 205-934-5287
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.