Clinical trial · Interventional
Legal Evaluation for Greater Access to Cancer Care (LEGAL-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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Legal Navigation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Legal Intervention Arm
- description
- 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.
- interventionNames
- Behavioral: Legal Navigation
Primary outcomes (1)
- measure
- Feasibility Benchmarks
- timeFrame
- 6 months
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available