Recruiting

LEGAL-CARE

Sponsor:

University of Alabama at Birmingham

Code:

NCT07197515

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Legal Navigation

Study Details

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

Study ID

NCT07197515

Start date

Oct 1, 2025

Status verified date

Feb, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Legal Intervention Arm

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.

Interventions

Legal Navigation

• 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.

Primary outcome measure

  • Feasibility Benchmarks [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Stacey A Ingram, MEd, CHES

205-934-5287saadewakun@uabmc.edu

Locations

The Kirklin Clinic

Recruiting

Birmingham, Alabama, United States, 35233

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Keywords

  • legal
  • navigation
  • legal barriers
  • cancer
  • oncology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-02-06.