CancerLEGAL-CARENCT07197515
Legal Evaluation for Greater Access to Cancer Care (LEGAL-CARE)
A study testing Legal Navigation in people with Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Legal Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New de novo advanced stage cancer (stages III/IV) requiring systemic therapy..
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Kirklin Clinic
Birmingham, Alabama, 35233
About this study
Official title: 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 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.
Read more
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.
Read the detailed description
Despite an adept social and navigation workforce, the regulatory and legal landscape for patients with cancer has become increasingly difficult to navigate. Many barriers faced by patients are entrenched in local, state, and federal policies that require expertise in both social needs and the law. Recently, the investigators led the first nationwide study investigating the extent to which patients with cancer encounter legal barriers related to disability, employment, health insurance, and financial assistance. There is an urgent need for evidence on how interventions can mitigate cancer-related legal barriers and impact care.
The Legal Evaluation for Greater Access to Cancer Care (LEGAL-CARE) is a pilot feasibility trial of a legal navigation program to address cancer-related legal barriers. A small cohort of patients will be offered at least one cycle of legal intervention over a 6-month period. Legal intervention is defined as a legal navigator proactively reaching out to the patient to discuss legal hardship during their treatment. This study will take place in the medical oncology clinics at the O'Neal Comprehensive Cancer Center. Inclusion criteria includes any adult aged 18 or older with a new diagnosis of advanced stage cancer (stages III or IV) requiring systemic therapy that is being seen in clinic. The objectives of this study are to evaluate the feasibility of a legal intervention, and understand patient perceptions utilizing semi-structured interviews. Additionally, it will assess patient-reported financial toxicity, quality of life, and health care utilization between patients receiving legal navigation. The investigators hypothesize this legal intervention would be feasible, acceptable and implemented as intended by the research protocol, while also demonstrating measurable improvement in patient outcomes.
The LEGAL-CARE study is relevant to the investigators' catchment area with a unique legal and regulatory landscape in Alabama, and situated in the context of recent American Society of Clinical Oncology (ASCO)-level and federal-level policy developments examining the role of legal services and SDOH in the context of cancer care. This study is significant as it will be the first to prospectively investigate the impact of legal barriers on patient care. It is innovative for multiple reasons. It employs a unique legal intervention and assesses the feasibility and acceptability of the intervention in preparation for a larger multi-site trial. It leverages a unique partnership between O'Neal's social work service, and the nation's largest organization providing legal assistance to patients with cancer, and community legal aid organizations in Birmingham. Finally, it results in a rich mixed methods analytic dataset that will allow implementation-related information from the intervention to be utilized in an R01 grant to scale this regionally.
- Conditions
- Cancer
- Being tested
- Legal Navigation
- Keywords
- legal, navigation, legal barriers, cancer, oncology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Legal NavigationBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Legal Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Benchmarks
Feasibility will be measured by
- retention of ≥70% of enrolled patients at 6 months and
- ≥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).
Measured: 6 months
Secondary outcomes (2)
Patient perceptions of legal intervention impact
Using semi-structured interviews, we will explore the effects of legal intervention on (1) legal barriers encountered during care, (2) perceived change in quality of life, (3) recommendations for modifying delivery intervention including dose, frequency, duration and content, and (4) current retention and future participation in clinical trials
Measured: At the end of 6 month legal intervention
Financial hardship, health-related quality of life, legal burden, administrative burden, and health care utilization
Financial toxicity measured by the Comprehensive Score for Financial Toxicity (COST-FACIT), range 0-44 with lower scores indicating worse toxicity.
Health-related quality of life measured by the Functional Assessment of Cancer Therapy - General (FACT-G), range 0-108 with higher scores indicating better quality of life.
Legal burden assessed by an investigator-developed questionnaire, with higher scores indicating greater burden.
Administrative burden assessed by an investigator-developed questionnaire, with higher scores indicating greater burden.
Health care utilization assessed from electronic medical record review, including emergency department visits, hospitalizations, intensive care admissions, urgent care visits, palliative care use, and treatment delays, reported as counts per patient at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Oct 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Triage Cancer
- Responsible party
- Principal investigator, Qasim Hussaini, University of Alabama at Birmingham
- Investigators
- Qasim M Hussaini, MD, MS, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197515
- Sponsor's protocol ID
- 300014052
- Other IDs
- UAB O'Neal Invest Award
- Acronym
- LEGAL-CARE
- Status last verified
- Feb 2026
- First submitted
- 3 Sep 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Consideration will be given to sharing of IDP as the study progresses.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07197515
- Acronym / sponsor ID
- LEGAL-CARE / 300014052
- Conditions
- Cancer
- Keywords
- legal, navigation, legal barriers, cancer, oncology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Triage Cancer
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Despite an adept social and navigation workforce, the regulatory and legal landscape for patients with cancer has become increasingly difficult to navigate. Many barriers faced by patients are entrenched in local, state, and federal policies that require expertise in both social needs and the law. Recently, the investigators led the first nationwide study investigating the extent to which patients with cancer encounter legal barriers related to disability, employment, health insurance, and financial assistance. There is an urgent need for evidence on how interventions can mitigate cancer-related legal barriers and impact care.
The Legal Evaluation for Greater Access to Cancer Care (LEGAL-CARE) is a pilot feasibility trial of a legal navigation program to address cancer-related legal barriers. A small cohort of patients will be offered at least one cycle of legal intervention over a 6-month period. Legal intervention is defined as a legal navigator proactively reaching out to the patient to discuss legal hardship during their treatment. This study will take place in the medical oncology clinics at the O'Neal Comprehensive Cancer Center. Inclusion criteria includes any adult aged 18 or older with a new diagnosis of advanced stage cancer (stages III or IV) requiring systemic therapy that is being seen in clinic. The objectives of this study are to evaluate the feasibility of a legal intervention, and understand patient perceptions utilizing semi-structured interviews. Additionally, it will assess patient-reported financial toxicity, quality of life, and health care utilization between patients receiving legal navigation. The investigators hypothesize this legal intervention would be feasible, acceptable and implemented as intended by the research protocol, while also demonstrating measurable improvement in patient outcomes.
The LEGAL-CARE study is relevant to the investigators' catchment area with a unique legal and regulatory landscape in Alabama, and situated in the context of recent American Society of Clinical Oncology (ASCO)-level and federal-level policy developments examining the role of legal services and SDOH in the context of cancer care. This study is significant as it will be the first to prospectively investigate the impact of legal barriers on patient care. It is innovative for multiple reasons. It employs a unique legal intervention and assesses the feasibility and acceptability of the intervention in preparation for a larger multi-site trial. It leverages a unique partnership between O'Neal's social work service, and the nation's largest organization providing legal assistance to patients with cancer, and community legal aid organizations in Birmingham. Finally, it results in a rich mixed methods analytic dataset that will allow implementation-related information from the intervention to be utilized in an R01 grant to scale this regionally.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Legal Intervention Arm | Experimental | Behavioral: Legal NavigationThere 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- New de novo advanced stage cancer (stages III/IV) requiring systemic therapy..
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Legal NavigationAlso: 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. | Behavioural | Legal Intervention Arm |
Primary outcome
Feasibility Benchmarks
Time frame: 6 months
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).
2 secondary outcomes
Patient perceptions of legal intervention impact
Time frame: At the end of 6 month legal intervention
Financial hardship, health-related quality of life, legal burden, administrative burden, and health care utilization
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Undecided. Consideration will be given to sharing of IDP as the study progresses.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qasim M Hussaini, MD, MS principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Legal Navigation in people with Cancer, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stacey A Ingram, MEd, CHES (205-934-5287, saadewakun@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Benchmarks (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.