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
Phase: NA
Conditions: Cancer
Sponsor: University of Alabama at Birmingham

PROTOCOL: Legal Evaluation for Greater Access to Cancer Care (LEGAL-CARE): A 
Randomized Pilot Feasibility Trial of a Legal Navigation Program 
Version Date: 2-17-2025 
 
Principal Investigator: 
Qasim Hussaini, MD MS 
Assistant Professor of Medicine 
O’Neal Comprehensive Cancer Center 
UAB Department of Medicine 
Email: shussaini@uabmc.edu 
 
Research Team and Key Personnel: 
Gabrielle Rocque, MD, MHS 
Associate Professor of Medicine 
O’Neal Comprehensive Cancer Center, UAB Department of Medicine 
Role: Primary Mentor 
Email: grocque@uabmc.edu 
 
Andres Azuero, PhD, MBA 
Professor of Nursing Family, Community & Health Systems 
School of Nursing 
Role: Biostatistician Mentor, Trial Design and Data Analysis 
Email: andreo@uab.edu  
 
Nicole Henderson, PhD 
Assistant Professor of Medicine 
O’Neal Comprehensive Cancer Center, UAB Department of Medicine 
Role: Collaborator, Qualitative Methogologies  
Email: nlhenderson@uabmc.edu  
 
Tanvi Padalkar, BS 
Clinical Research Coordinator, Division of Hematology & Oncology, UAB 
Role: Patient Interviews  
Email: tpadalkar@uabmc.edu  
 
Luqin Deng, PhD 
Statistician and Scientist III 
Division of Preventive Medicine, UAB Department of Medicine 
Role: Research Analyst 
Email: lqdeng@uab.edu  
 
 
 
 
 
 
 
 
 
 

1. Study Overview 
Background and Rationale: 
Despite an adept 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. Our group 
led the first nationwide study investigating the extent to which patients with cancer encounter 
unmet legal needs related to disability, employment, health insurance, and financial assistance. 
The Legal Evaluation for Greater Access to Cancer Care (LEGAL-CARE) is a randomized pilot 
trial to test the feasibility of a legal navigation program. The goal is to address a critical gap in 
cancer care where patients carry high unmet legal need. 
 
Study Design: 
This is a single arm, pilot feasibility trial where 50 recruited patients will receive monthly 
outreach from a legal navigator over a 6-month period to address legal hardships during their 
treatment. This study will take place in UAB’s medical oncology clinics and include patients 
aged 18 or older with newly diagnosed advanced stage cancer (stages III or IV) requiring 
systemic therapy. We hypothesize the legal intervention will be feasible, acceptable and improve 
patient outcomes. 
 
2. Objectives 
Primary Objective:  
• 
Assess the feasibility of implementing a legal navigation intervention: Defined as a 
70% retention rate and 75% completion of survey completion (at 3 and 6 months) during 
the 6-month intervention period. Retention and completion rates will be summarized with 
95% confidence intervals. 
 
Secondary Objectives: 
• 
Assess the acceptability and appropriateness of implementing a legal navigation 
intervention 
• 
Collect patient feedback through semi-structured interviews to inform future large-scale 
trials. 
• 
Explore the impact of the legal navigation program on financial toxicity, quality of life, 
treatment delays, and healthcare utilization. 
 
3. Study Population 
Inclusion Criteria: 
• 
Adult patients aged ≥18 years. 
• 
Newly diagnosed with advanced-stage cancer (Stage III or IV). 
• 
Requiring systemic therapy. 
• 
Capable of providing informed consent. 
 
Exclusion Criteria: 
• 
Non-melanoma skin cancer or in-situ tumors. 
• 
Patients with prior hospice encounters within the past year. 
• 
Patients who are unable to participate in study procedures. 
 
4. Study Procedures 
 
Sample size: 

As a pilot study, no hypotheses are being tested 1 (https://www.nccih.nih.gov/grants/pilot-
studies-common-uses-and-misuses) therefore the study sample size is based on budgetary and 
logistic considerations to evaluate feasibility goals. 
 
Screening and Enrollment: 
Eligible participants will be identified during their oncology clinic visits and provided with 
information about the trial (please see Appendix A for patient education materials). After 
informed consent is obtained (please see Appendix B for informed consent), baseline 
assessments (noted below) will be conducted, before the legal intervention commences. 
 
Data Collection: 
• 
Baseline: Demographics, medical history, and baseline survey of legal barriers and 
financial toxicity (COST-FACIT) and quality of life (FACT-G7) (Appendices C-D). You 
need to describe all the surveys, number of questions, and scoring here.  
• 
Follow-Up: Surveys at 3 months and 6 months will assess changes in financial toxicity 
(COST-FACIT) and quality of life (FACT-G7). Additional surveys at these time points will 
include Assessing the Feasibility of Intervention (AIM), Intervention Acceptability 
Measure (IAM), and Feasibility of Intervention Measure (FIM) surveys (Appendix E). 
Information on delays in care (measured in days from first appt in our clinic to first visit 
for systemic treatment) and healthcare utilization (ER visits, urgent care visits, 
hospitalizations, ICU-level admissions, and palliative care uptake) will be obtained from 
the EMR at UAB (please see Appendix F for EMR collection elements). 
• 
Qualitative Interviews: Conducted at the end of the 6-month intervention period to 
explore patient experiences and perceptions of legal intervention (please see Appendix 
G for interview guide outline) 
 
Participant Incentives: 
Participants will receive $30 at the end of completion of all surveys, and $50 for interviews. 
These incentives may be increased during the study period to maintain participation. 
 
5. Study Intervention 
Please see study schema below following details on  
 
 
Intervention Overview: 
• 
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. Legal navigator team will be from Triage Cancer, a 

nationwide non-profit organization with a track record of assisting patients with legal 
barriers following a cancer diagnosis. 
• 
While some of the challenges patients face-such as disability benefits, employment 
discrimination, health insurance denials, and financial assistance-may also be 
encountered by social workers, the role of legal navigators is distinct to that of social 
workers. Legal navigators specialize in interpreting and applying legal frameworks, 
understanding state and federal regulations, and providing direct legal guidance in areas 
where legal expertise is critical. For e.g., while a social worker may be able to re-direct a 
patient at risk of losing housing or financial assistance to additional community 
resources, a lawyer is able to help the patient interpret legal rights, assist with required 
paperwork, and provide guidance on navigating legal systems to remove barriers. 
Similarly, when a patient loses their job, experiences discrimination, or cannot be hired 
due to a cancer diagnosis and is losing their disability and/or employment benefits, it is 
the lawyer that is able to help the patient understand their legal rights. You require two 
completely different skillsets to assist with these, one that a social worker does not carry 
– that a legal navigator is trained to assist with 
• 
This legal navigation approach ensures that patients receive specialized legal expertise 
in addressing complex, systemic barriers while complementing, rather than overlapping, 
social work services. 
 
Intervention Details: 
1. Monthly Outreach by Legal Navigator: 
• 
Frequency and Mode of Communication: 
o 
Participants will receive one scheduled outreach per month for six months. 
o 
Communication will be conducted via phone calls, with an option for virtual 
consultations based on participant preference. 
o 
Each session will last approximately 30–60 minutes, depending on the 
complexity of the participant’s needs. 
• 
Discussion Topics: 
During each outreach session, the legal navigator will: 
o 
Identify new or ongoing legal barriers (e.g., insurance denials, employment 
disputes, housing issues etc). 
o 
Review progress on previously identified issues and any actions taken. 
o 
Provide tailored guidance and resources for addressing specific legal concerns. 
o 
Offer general legal education on topics such as: 
 
Health Insurance Navigation: Medicaid/Medicare issues, private 
insurance appeals, COBRA, and coverage gaps. 
 
Employment Rights: Understanding FMLA, ADA protections, and 
wrongful termination. 
 
Disability Benefits: Applying for Social Security Disability Insurance 
(SSDI), Supplemental Security Income (SSI), or appealing denied claims. 
 
Financial Assistance: Locating and applying for programs that provide 
assistance with medical bills, rent, or utilities. 
 
Estate Planning and Directives: Creating or updating wills, advance 
directives, or power of attorney documents. 
2. Tailored Legal Support: 
• 
Legal navigators will assess each participant's unique situation and provide step-by-step 
instructions or direct assistance in resolving legal issues. 
• 
For cases requiring specialized legal expertise or representation, participants will be 
referred to local resources, including Legal Services Alabama or other partner 
organizations. 

3. Proactive Follow-Up: 
• 
Navigators will follow up with participants regarding unresolved legal issues or new 
developments. Follow-ups will occur between monthly sessions if required. 
4. Between-Session Support: 
• 
Participants may initiate contact with the legal navigator team between monthly sessions 
for new or urgent legal concerns. 
• 
Legal navigators will respond to patient inquiries within 2–3 business days and prioritize 
urgent issues such as impending housing eviction or denial of time-sensitive treatments. 
5. Documentation:  
• 
All interactions, including participant concerns, recommendations, and resolutions, will 
be documented in a secure system. This documentation will track intervention fidelity 
and outcomes. 
6. Participant Resources: 
• 
Participants will receive educational materials (print or electronic) summarizing key legal 
rights and resources discussed during the outreach sessions. 
 
6. Data Management 
Data Collection Methods: 
• 
All survey will be collected through REDCap, a secure, web-based application for 
managing research data. 
• 
All interview data will be managed and analyzed using NVivo, a secure software 
designed for qualitative data management and analysis 
• 
Information on delays in care (measured in days from first appt in our clinic to first visit 
for systemic treatment) and healthcare utilization (ER visits, urgent care visits, 
hospitalizations, ICU-level admissions, and palliative care uptake) will be obtained from 
the EMR at UAB (please see Appendix F) 
 
Data Monitoring: 
The principal investigator (Dr. Qasim Hussaini), and clinical research coordinators (Ms. Indya 
Starks and Ms. Tanvi Padalkar) will regularly monitor data quality and completeness. An 
independent data monitoring committee (DMC) will be established to oversee the integrity of the 
data and patient safety. 
 
7. Statistical Analysis Plan 
Primary Outcome: 
• 
Feasibility: Defined as a 70% retention rate and 75% completion of surveys (at 3 and 6 
months) during the 6-month intervention period. Retention and completion rates will be 
summarized with 95% confidence intervals. 
Sample size: We will recruit 50 patients to assess intervention feasibility, with no power 
calculation needed as efficacy is not the primary objective 1. As a pilot study and consistent with 
NIH guidance, the sample size is not powered for formal statistical inference but was considered 
based on examining the feasibility and acceptability of the approach and on refining the 
intervention design and procedures in preparation for a future larger proposal 2.  
 
Analytical approach: Led by the Dr. Hussaini (PI) with input from Dr. Andres Azuero (co-mentor 
biostatistician) and implemented by staff analyst, Dr. Luqin Deng (research analyst/statistician). 
 
Assess feasibility of the intervention: Proportions of: a) eligible approached patients that 
accept to trial participation; b) proportion of participating patients retained at follow-up; and c) 
proportion of participating patients completing at least 75% of surveys, will be estimated and 

confidence intervals will be computed with simple logistic or probit regression models and inverse 
link transformations. Descriptive statistics and measures of effect size (e.g., Cohen’s d, Cramer’s 
V) will be used to explore association between the proportions of interest and participant 
sociodemographic characteristics and reported legal barrier types. 
 
Secondary Outcomes: 
Explore patient perceptions of legal intervention impact: We will use qualitative 
methodology therefore biostatical approaches are not applicable. Sampling for qualitative 
inquires is sequential and targeted to individuals who can provide insights on the processes 
under study. Typically, pilot qualitative approaches involve ~20 participants and expect to have a 
sufficient participant pool to carry out the qualitative inquiry 3,4. This sample size follows 
qualitative research best practices, ensuring thematic saturation while maintaining feasibility 
within the study timeline. If thematic saturation is not reached, we will increase this number. 
 
Evaluate trajectory of financial hardship, health-related quality of life, delays in care, and 
health care utilization: Brief description followed by detailed statistical plan 
• 
Financial Toxicity: Changes in COST-FACIT scores will be analyzed using linear mixed-
effect models. 
• 
Quality of Life: FACT-G7 scores will be analyzed at baseline, 3 months, and 6 months, with 
adjustments for baseline values. 
• 
Delays in Care: Time-to-event analysis will be conducted using Cox proportional hazards 
models, comparing the time from diagnosis to treatment initiation between the two groups. 
• 
Healthcare Utilization: Emergency department visits and hospitalizations will be analyzed 
using generalized linear mixed models. Results will be presented as mean ratios or odds 
ratios. 
 
Here we will use repeated measures (baseline, 3 month, and 6 months post-intervention) of 
survey measures (collected directly) and utilization rates (extracted from EHR). Baseline 
characteristics and outcomes will be examined with descriptive statistics and measures of effect 
size. For survey outcome scales (COST-FACIT and FACT-G7), linear mixed-effect models will be 
fitted with all available data to estimate mean outcomes at each time-point by group. Linear 
contrasts will be used to estimate mean differences between groups at the follow-up times, 
adjusted for baseline and 95% confidence intervals will be computed. The models will be of the 
form 𝑌𝑌𝚤𝚤𝚤𝚤
෢= 𝛽𝛽0 + 𝛽𝛽1𝑌𝑌0 + 𝛽𝛽2 𝑇𝑇1 + 𝛽𝛽3𝑇𝑇6 + 𝛽𝛽4 𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿+ 𝛽𝛽5𝑇𝑇1 × 𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿+ 𝛽𝛽6𝑇𝑇6 × 𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿+ 𝛾𝛾𝑖𝑖 , where 
𝑌𝑌𝚤𝚤𝚤𝚤
෢ is the value of an outcome for subject i  at time j, 𝛽𝛽1 is the coefficient for the baseline outcome 
value (𝑌𝑌0),  𝛽𝛽0,  𝛽𝛽2, 𝛽𝛽3 are coefficients specific to the reference group (enhanced usual care), 
𝛽𝛽4,  𝛽𝛽5, 𝛽𝛽6 are coefficients specific to the legal intervention group, 𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿 is a binary indicator of 
group, 𝑇𝑇1 is a binary indicator for time at 1-month post-intervention, and 𝑇𝑇6 is a binary indicator 
for 6 months. Linear combinations of model coefficients allow estimation of means by group as 
well as mean differences. The between-group contrast at 1-month post-intervention (adjusted for 
baseline) is estimated by  𝛽𝛽4 +  𝛽𝛽5 , and the between-group contrast at 6-months (adjusted for 
baseline) is estimated by 𝛽𝛽4 +  𝛽𝛽6. Baseline SDs will be used to rescale the contrasts into 
standardized measures of effect (Cohen’s d). For delays in care, we will use time-to-event 
analysis methods, such as Cox proportional hazards models, to compare the time from new 
diagnosis to treatment initiation between enhanced usual care and legal intervention groups. 
Hazard ratios will be estimated with 95% confidence intervals. For health care utilization 
measures, generalized linear mixed-effect models will be used. Here, a link-transformation of the 
expected outcome value is modeled. For discrete count outcomes (e.g. urgent care visits) a 
default link-transformation is the natural logarithm of the mean, and for binary outcomes (e.g. 
whether a hospitalization occurred) a default link-transformation is the natural logarithm of the 

odds (𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜= 𝑝𝑝[1 −𝑝𝑝])
⁄
. Inverse-link transformations will be used to estimate estimated 
expected values of the outcomes by group at each time-point. For count outcomes, contrasts are 
estimated as mean ratios, and for binary outcomes contrasts can be estimated as odds ratios 
(default) or as relative risks (if the model is fitted with a log-link and a robust standard error). 95% 
confidence intervals will be computed. We will use SAS (version 9.4M8) and R (version 4.4.2) for 
the statistical analysis of quantitative data. 
8. Safety and Adverse Events 
Safety Monitoring: 
Any adverse events related to the legal intervention will be recorded and reported to the IRB. 
Although legal navigation is a low-risk intervention, any significant issues related to stress, 
patient dissatisfaction, or legal complications will be addressed by the study team. 
 
9. Ethical Considerations 
This study will be conducted in accordance with the Declaration of Helsinki and Good Clinical 
Practice (GCP) guidelines. Informed consent will be obtained from all participants, and 
confidentiality will be maintained. Study approval is on track to be obtained from the UAB 
Institutional Review Board (IRB). 
 
10. Dissemination of Results 
The results of this trial will be published in peer-reviewed journals and presented at major 
oncology conferences, including ASCO and/or ASCO Quality Care Symposium. Patient-friendly 
summaries will also be disseminated through advocacy organizations and local clinics. 
Collaboration with Legal Services Alabama and Triage Cancer will help ensure broader 
dissemination to policy-makers and healthcare providers. 
 
11. Timeline 
Milestone 
Timeline 
IRB Approval and Protocol Finalization 
Pre Grant 
Training Phase 
Months 1-3 
Recruitment Initiation 
Month 4 
Completion of Enrollment 
Month 16 
Primary Data Collection (Baseline, 3-month, 6-month) Months 4-24 
Data Analysis 
Months 14-26 
Manuscript Preparation 
Months 24-30 
Dissemination 
Months 28-36 
 
12. Conclusion: 
The LEGAL-CARE study addresses a critical gap in cancer care where patients carry high 
unmet legal need, and existing support structures—both at home and within medical teams—are 
inadequate to manage these unmet legal needs. It will be the first oncology study to evaluate the 
feasibility of proactive legal navigation intervention and assess its impact on patient outcomes. It 
will create a unique partnership between a cancer center and its providers and social workers, 
local legal aid groups in Alabama, and national non-profit legal groups in the US. Finally, the 
LEGAL-CARE study will provide key implementation insights in preparation for a larger multi-site 
trial that may support the scalability and long-term sustainability of legal interventions in cancer 
care in diverse geographic and clinical settings. 
 

14. Appendices 
• 
Appendix A – Patient Education Materials 
• 
Appendix B – Patient Consent Form 
• 
Appendix C – Survey Instruments (COST-FACIT) 
• 
Appendix D – Survey Instruments (FACT-G7) 
• 
Appendix E – Survey Instruments (AIM, IAM, FIM) 
• 
Appendix F – EMR Collection Elements 
• 
Appendix G – Interview Guides 
 
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https://www.nccih.nih.gov/grants/pilot-studies-common-uses-and-misuses 
2. 
Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility 
Pilot Studies. Med Care. 2022;60(1):95-103. 
3. 
Polit, D.f. and beck, C.t. (2017) Nursing Research Generating and Assessing Evidence for 
Nursing Practice. 10th Edition, Wolters Kluwer Health, Philadelphia, 784 p. - references - 
scientific research publishing. Accessed October 3, 2024. 
https://www.scirp.org/reference/referencespapers?referenceid=2325091 
4. 
Hennink M, Kaiser BN. Sample sizes for saturation in qualitative research: A systematic 
review of empirical tests. Soc Sci Med. 2022;292(114523):114523.