Evaluating the Implementation and Impact of Standard-of-care Delivered Oncology Financial Navigation
Phase: NA
Conditions: Oncology, Financial Toxicity, Counseling
Sponsor: University of Alabama at Birmingham

Cover Page 
 
Official Title: Evaluating the implementation and impact of standard-of-care delivered oncology financial 
navigation 
 
NCT Number: Pending 
 
Date of document: February 28, 2025 
 

2 
 
Study/Protocol Title: Evaluating the implementation and impact of standard-of-care delivered oncology 
financial navigation 
 
Table of Contents: 
1. Background and Significance 
2. Study Objectives 
3. Design Considerations and Preliminary Studies 
4. Investigation Plan and Study Procedures 
5. Data Analysis  
6. Data and Safety Monitoring  
7. Benefits 
8. Potential Risks and Solutions 
9. Confidentiality 
10. References 
 
Primary Investigator:  
Courtney P. Williams, DrPH 
Assistant Professor 
Division of Preventive Medicine, University of Alabama at Birmingham 
1720 2nd Avenue South, MT 639, Birmingham, AL 35294 
Office: (205) 975-0462 
courtneywilliams@uabmc.edu 
 
Mentors: 
Gabrielle B. Rocque, MD, MSPH 
Associate Professor, Division of Hematology & Oncology, UAB Department of Medicine 
grocque@uabmc.edu  
 
Lisa Zubkoff, PhD 
Associate Professor, Division of Preventive Medicine, UAB Department of Medicine 
lisazubkoff@uabmc.edu  
 
Janet Turan, PhD, MPH 
Professor, Department of Health Policy and Organization, UAB School of Public Health 
jmturan@uab.edu  
 
Collaborators:  
Maria Pisu, PhD 
Professor, Division of Preventive Medicine, UAB Department of Medicine 
mpisu@uabmc.edu 
 
Andres Azuero, PhD, MBA 
Professor, Department of Family, Community, & Health Systems, UAB School of Nursing 
andreo@uab.edu 
 
Statisticians: 
Luqin Deng, PhD 
Scientist III, Division of Preventive Medicine, UAB Department of Medicine 
luqindeng@uabmc.edu  
 
Sandra Olisakwe, MSPH 
Clinical Data Analyst, Division of Hematology & Oncology, UAB Department of Medicine 
scolisakwe@uabmc.edu  
 
 

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1. Background and Significance 
a. Financial hardship, defined as out-of-pocket costs and their accompanying financial 
distress, is a significant issue for individuals with cancer. Financial hardship often results in 
adverse (1) material outcomes, such as trading off spending on food or housing to pay for 
medical bills; (2) behavioral outcomes, by delaying or foregoing medical care due to costs; and 
(3) psychological outcomes, through increased distress and decreased quality of life.1 
Additionally, patients who are minoritized, rural residents, underinsured, or socioeconomically 
disadvantaged are at inequitably higher risk for cancer-related financial hardship.2-13 Addressing 
high out-of-pocket costs and financial distress is imperative for ensuring favorable outcomes for 
individuals with cancer.  
 
b. Financial hardship screening data is routinely collected and reveals high levels of 
financial hardship in patients receiving oncologic care at the University of Alabama at 
Birmingham (UAB). Financial hardship screening measures were incorporated into an 
electronic medical record (EMR)-integrated, standard-of-care, treatment planning survey 
implemented at UAB as a Center for Medicare and Medicaid Innovation’s (CMMI) Oncology 
Care Model practice transformation activity.14-16 Screening has been conducted since 2020 
either electronically pre-clinic visit or by a trained lay navigator in-person at routine clinic visits or 
over the phone. Financial hardship screening is comprised of (1) the validated 11-item 
COmprehensive Score for financial Toxicity (COST) tool to capture cancer-related financial 
distress,17, 18 and (2) ten individual domains of financial difficulty, including trouble paying for 
basic needs, utilities, transportation or lodging for treatment, medications, medical supplies, 
upfront medical payments, insurance or medical bills, child or eldercare, and employment or 
disability issues. Of ~3,000 UAB oncology patients screened through May 2023, 34% were 
experiencing financial distress. Reported distress also differed by race, with 49% of Black 
patients screening positive for financial distress compared to 30% of White patients. Differences 
in types of financial difficulties were seen comparing Black and White patients, including 44% 
vs. 23% reporting difficulty with upfront medical payments and 28% vs. 12% reporting financial 
difficulties with transportation for care, respectively.19 Though high levels of financial hardship 
exist, how to routinely address patient-reported financial hardship in clinical settings using 
evidence-delivered interventions is unknown. 
 
c. Oncology financial navigators, a new health care team member, could aid in reducing 
patient-reported financial hardship. Oncology financial navigation is an evidence-based 
intervention which helps patients prepare for out-of-pocket treatment costs, optimize health 
insurance, and access financial resources to reduce cancer-related financial hardship (see 
Section C for a detailed description of financial navigation components).20 Results from 
research-based, pilot, oncology financial navigation studies indicated this intervention was 
feasible and showed high patient acceptability and appropriateness.21 Additionally, research-
based evaluations have shown oncology financial navigation interventions result in decreased 
patient financial hardship, financial anxiety, and individual annual savings of >$30,000.22-26 
Though research-based integration of oncology financial navigators has been proven beneficial 
for patients in controlled settings, little is known about how to implement oncology financial 
navigation into routinely-delivered oncologic care, especially for systems serving patients 
experiencing large inequities in financial hardship. Thus, evaluation of oncology financial 
navigation integration into real-world clinical care, especially for highly diverse and under-
resourced patient populations, is needed to ensure equitable implementation. 
 
2. Study Objectives 
Guided by the RE-AIM Extension for Equitable Sustainability framework,27 we will use a series of 
implementation and effectiveness aims to evaluate equitable implementation of oncology financial 
navigation into routine cancer care delivery. This study will build upon my existing skills in quantitative 
research methods, which has provided foundational work to better understand cancer-related financial 
hardship, and allow me to develop new skills in implementation science, pragmatic trials, and 
qualitative methods to address financial hardship. We hypothesize the proposed assessment will 
identify potential areas to improve implementation of oncology financial navigation, which will result in 
better financial and clinical outcomes for patients with cancer. We propose a pragmatic, hybrid 
effectiveness-implementation study28 to assess outcomes of oncology financial navigation delivered as 

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routine cancer care and collect information on strategies to address implementation barriers. Outcomes 
will be assessed overall and for inequities by race, residence, and insurance status using the following 
specific aims: 
Aim 1. Track oncology financial navigation implementation strategies and their effect on 
implementation outcomes. We will track oncology financial navigation implementation 
strategies (using the Longitudinal Implementation Strategy Tracking System29) and effect on 
outcomes, including reach (patients who receive financial navigation), adoption (positive 
financial hardship screens addressed), implementation fidelity (proportions of financial 
navigation core components completed), and maintenance (≥3 months of ≥60% of positive 
financial hardship screens addressed with ≥60% of core components completed). Training goal: 
Dr. Lisa Zubkoff will provide mentorship in implementation science frameworks, strategies, 
outcomes.  
 
Aim 2. Evaluate oncology financial navigation effectiveness. For patients receiving 
oncology financial navigation compared to historical controls (“usual care”), we will use routinely 
collected, patient-reported data to evaluate change in patient-reported measures of financial 
distress (COmprehensive Score for financial Toxicity17), financial difficulties (10 individual 
domains, such as transportation to care or prescriptions), quality of life (PROMIS v1.1 Global 
Health30), and psychological distress (National Comprehensive Cancer Network Distress 
Thermometer31). Training goal: Dr. Gabrielle Rocque will provide mentorship in pragmatic trial 
conduct and design. 
 
Aim 3. Assess how implementation strategies were utilized to overcome barriers to 
oncology financial navigation. Using qualitative interviews, we will assess how oncology 
financial navigation implementation strategies were leveraged to address implementation 
barriers identified from patient (N=20), provider (N=10), and health system (N=10) perspectives. 
Training goal: Dr. Janet Turan will provide mentorship in qualitative methodologies. 
 
3. Design Considerations and Preliminary Studies 
a. Design Considerations. This evaluation of oncology financial navigation implementation 
outcomes and effectiveness is intentionally designed to be a pragmatic evaluation of largely 
secondary data. UAB rolled out routine financial hardship screening in 2020. To respond to the 
high prevalence of financial hardship identified by screening in our patient population, UAB is 
currently prioritizing the hiring and integration of oncology financial navigators into clinical 
teams, independent of this grant mechanism. We will leverage this screening data, which is 
available in the EMR (Aims 1&2), that have been collected since 2020 (Aim 2), and which will 
trigger oncology financial navigation (Aim 1), to achieve our aims. Thus, we will not conduct a 
formal randomized control trial or select outcomes not already included in our standard-of-care 
screening data. The pragmatic nature of this study, as well as the >3,000 patients with financial 
hardship screening data already collected, greatly strengthens our study. 
 
b. Preliminary studies.  
i. 
Successful navigation program supporting cancer patients utilized 
implementation strategies. Drs. Rocque (primary mentor), Pisu (collaborator), and 
Williams (PI) implemented and evaluated a lay navigation program across 12 
southeastern cancer centers, including UAB.32, 33 Over a 3-year period, this program 
employed non-clinical lay navigators to provide support to >10,000 cancer patients.34 
Lay navigators used routine distress screenings to identify barriers to care and empower 
patients to overcome these barriers.35 Lay navigators were able to address 92% of 
patient concerns, and 90% of patients would recommend the program to others.34 This 
project highlights the team’s experience working with navigators and evaluating the 
impact of novel delivery approaches on patient outcomes. 
 
ii. 
Assessment of real-world data for program evaluation. Drs. Rocque (primary 
mentor), Azuero (collaborator), and Williams (PI) conducted a pragmatic study of real-
world implementation of remote symptom monitoring using patient-reported outcomes at 
UAB. The evaluation integrated EMR, registry, and patient-reported outcome data in 
>2,000 patients to demonstrate implementation success. Preliminary data shows a 20% 

5 
 
reduction in hospitalizations at 6 months (HR 0.8, 95% CI 0.6-1.1). To achieve these 
results, 39 distinct implementation strategies were utilized in initial implementation and 
scale-up. Strategies were linked with qualitative interview data to describe utility of 
implementation strategies using LISTS (preliminary data presented at 2023 Academy 
Health Annual Meeting for Dissemination and Implementation Science). This project 
demonstrates capacity to conduct pragmatic implementation evaluation of standard-of-
care interventions within large patient populations. 
 
4. Investigation Plan and Study Procedures 
a. Aim 1. Track oncology financial navigation implementation strategies and their effect on 
implementation outcomes. 
i. 
Objectives: (1) Track oncology financial navigation implementation strategies and (2) their 
effect on implementation outcomes overall and by race, residence, and insurance status. 
ii. 
Approach: Use secondary data routinely collected in the EMR and EMR-embedded 
navigation software to evaluate implementation strategies and outcomes over time. 
iii. 
Sampling: Oncology financial navigation is a high priority for the UAB Cancer Service Line 
and will be implemented as standard of care, independent of this study. Oncology financial 
navigators will approach all patients receiving systemic cancer treatment (chemotherapy, 
immunotherapy, targeted therapy). No consent will be required as this will be a standard-of-
care intervention offered to all patients. The oncology financial navigator will review the 
patient-reported financial distress and difficulty data and if necessary, triage to appropriate 
care team members (psycho-oncology, lay navigation, social work). Dr. Williams (PI) has 
been working closely with the Medical Director of Quality for the UAB Cancer Service Line 
(Dr. Rocque; primary mentor), Director of Program Planning & Performance Improvement 
for the UAB Cancer Service Line, and Manager of UAB Ambulatory Oncology Social Work & 
Lay Navigation to develop the oncology financial navigator program, including evidence-
based20 core components specific for the UAB oncology financial navigators. These include 
(1) individualized estimations of out-of-pocket costs based on each patient’s health 
insurance plan, (2) patient education on insurance, billing, and employment, and (3) patient 
assistance with copay assistance or charity care requests. As oncology financial navigation 
will be implemented as standard of care, implementation outcomes will be evaluated for (1) 
all patients with cancer seen at the UAB Medical Oncology clinic, and (2) UAB oncology 
financial navigators. 
iv. 
Training: In addition to standard onboarding from the UAB Health System, Dr. Williams (PI) 
and key implementation team members (including Dr. Pisu [collaborator]) will conduct 
training specific for oncology financial navigators. Training materials will include modules 
from the Association of Community Cancer Centers Financial Advocacy Bootcamp, George 
Washington University’s Oncology Financial Navigation Training, and Triage Cancer’s Legal 
and Financial Navigation Program.  
v. 
Data collection: Implementation outcome data will be abstracted from the EMR and 
HealtheCare, the EMR-embedded navigation software. Data uncaptured by the EMR and 
navigation software will be captured during implementation meetings with the 
implementation team and oncology financial navigators. 
vi. 
Implementation strategies: Implementation strategies (Table 1) were identified a priori by the 
implementation team. During implementation, Dr. Williams (PI) will use the LISTS36 tool to 
track implementation strategy utilization using the Expert Recommendations for 
Implementing Change (ERIC37) compilation. Implementation strategies will be assessed 
quarterly through formal tracking using the LISTS REDCap38 tool and reviewed with Dr. 
Zubkoff (co-mentor) and the larger mentorship team (GR, JT). 
 
Table 1. Potential implementation barriers, selected implementation strategies, planned actions, and potential interview prompts.   
Barrier 
Implementation strategy 
Action 
Aim 3 interview prompts 
Clinical staff unaware of 
financial navigators 
Identify and prepare champions 
Implementation team 
trains staff champions 
What have you done to build buy-in 
for the financial navigation program? 
Financial navigators are 
untrained 
Conduct ongoing training 
Implementation team 
trains all financial 
navigators 
What were the strengths and 
weaknesses of the financial 
navigation training? 

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Resources for financial 
navigators are 
uncharacterized 
Develop resource sharing 
agreements 
Implementation team 
creates baseline set of 
resources  
What resources were needed to 
address patient financial needs? 
Patient financial needs 
historically addressed by 
social workers 
Revise professional roles 
Clinical team will 
introduce financial 
navigator to patient 
What was the level of patient 
awareness regarding financial 
navigation services? 
Implementation strategies 
not addressing contextual 
needs 
Purposely reexamine the 
implementation 
Implementation team 
adjusts implementation 
strategies 
How did adjustment of 
implementation strategies respond to 
financial navigation program needs? 
 
vii. 
Implementation outcomes: Implementation outcomes (Table 2) will be anchored in the RE-
AIM Extension for Equitable Sustainability.27 All patient outcomes will be assessed both for 
the overall population of interest, and for inequities by patient subgroups, including race 
(white, Black/person of color), residence (rural, urban), and insurance status (private, 
Medicare, Medicaid, other, uninsured). Implementation reach, adoption, fidelity, and 
adaptation will be captured monthly, while implementation maintenance will be captured 
annually. 
 
Table 2. Project aim outcomes, concepts, units of assessment, evaluation metrics, and evaluation timing. 
Aim 
Outcome* 
Concept 
Unit of 
assessment 
Evaluation metrics 
Evaluation 
timing 
1 
Utilization of 
implementation 
strategies 
Expert Recommendations for 
Implementing Change (ERIC) 
implementation strategies37 
Patients,  
providers, 
health system 
Longitudinal Implementation Strategy 
Tracking System (LISTS)29 
Quarterly 
 
Implementation 
outcomes 
Reach 
Patients 
Proportion who receive OFN; 
Characteristics of participants vs. non-
participants 
Monthly 
Adoption 
Oncology 
Financial 
Navigators 
Proportion who participate in training; 
Average positive financial hardship screens 
addressed; Time to response; Type of 
response to positive screens 
Implementation fidelity and 
adaptation 
Oncology 
Financial 
Navigators 
Proportions of core components 
completed; Consistency of OFN-delivered 
core components across patient 
subgroups; Adaptations to OFN; Reasons 
for adaptations 
Maintenance 
System 
Proportion of OFN with ≥3 months of ≥60% 
of positive financial hardship screens 
addressed with ≥60% of OFN core 
components completed 
Annually 
2 
Effectiveness 
outcomes 
Financial distress 
Patients 
COmprehensive Score for financial 
Toxicity17 
Six-month 
change 
scores 
Financial difficulties 
Proportion reporting ten individual domains 
of financial difficulty 
Quality of life 
PROMIS v1.1 Global Health30 
Psychological distress 
National Comprehensive Cancer Network 
Distress Thermometer31 
3 
Patient, 
provider, and 
health system 
perspectives 
Implementation barriers  
addressed via  
implementation strategies 
Patients 
Patient subgroups unreached by OFN; 
Effectiveness of OFN-delivered services for 
certain patient subgroups 
Annually 
Providers and 
health system 
Consistency of OFN-delivered core 
components; OFN capacity and resources 
*Outcomes will be assessed overall and by patient race, residence, and insurance status. OFN=Oncology Financial Navigation 
 
b. Aim 2. Evaluate oncology financial navigation effectiveness. 
i. Objectives: To evaluate the effectiveness of oncology financial navigation overall and for 
inequities by race, residence, and insurance status using the change in patient-reported 
financial distress, financial difficulties, quality of life, and psychological distress for 
patients receiving oncology financial navigation compared to historical controls (“usual 
care”). 
ii. Approach: To use existing, routinely collected, patient-reported data to compare 
outcomes from patients receiving oncology financial navigation to matched historical 
controls. 

7 
 
iii. Sampling: This will be a secondary data analysis of patient-reported data routinely 
collected since 2020 for patients with cancer seen at the UAB Medical Oncology clinic. 
All patients with data will be included in the analysis, as this is an evaluation of oncology 
financial navigation integration into real-world clinical teams. Therefore, due to a lack of 
comparable controls during the oncology financial navigation intervention, we will use 
historical controls matched by sociodemographic and cancer characteristics for 
comparison. To minimize confounding, we will use data reported by UAB Medical 
Oncology patients from the previous 3 years. Patient data and sources are shown in 
Table 3. 
 
c. Aim 3. Assess how implementation 
strategies were utilized to overcome 
barriers to oncology financial 
navigation. 
i. Objectives: Assess perceptions of 
how selected implementation 
strategies were used to address 
implementation barriers from the 
patient, provider, and health system 
perspectives. 
ii. Approach: Conduct semi-structured 
qualitative interviews from diverse 
perspectives to assess 
implementation barriers and 
adequacy of strategies to overcome 
barriers. 
iii. Sampling: We will identify individuals to participate in 30-60 minute-long interviews. 
Patient participants (N=20) will be purposively selected using maximum variation 
sampling to ensure representation of differing races, residences, and insurance 
statuses. Provider (oncology financial navigators, social workers, nurse managers, 
oncologists; N=10) and health system (billing specialists, cancer service line leadership; 
N=10) participants will be selected using purposive sampling of individuals involved with 
the oncology financial navigation program. A $50 participation incentive will be provided. 
 
5. Data Analysis 
a. Aim 1. Track oncology financial navigation implementation strategies and their effect on 
implementation outcomes. 
i. Statistical analysis: Descriptive statistics will be calculated for oncology financial 
navigator sociodemographics, patient sociodemographics and clinical characteristics, 
and implementation outcomes. Oncology financial navigation will be delivered as 
standard of care. However, patient sociodemographics who decline oncology financial 
navigation will still be collected and compared to examine the implementation outcome 
of reach using bivariate measures of association (e.g. Cohen’s d, Cramer’s V). For 
patient-level outcomes, the oncology financial navigator will be treated as a fixed effect 
when needed. Primary analyses will use binomial logit models to estimate proportions of 
implementation outcomes (Table 2). Models will estimate time trends for implementation 
outcomes using a categorical coefficient for quarter. Model-predicted means and 
inverse-link transformations will be used to estimate proportions of implementation 
outcomes and respective 95% confidence intervals. Secondary analyses for patient-level 
outcomes will use logit models to evaluate the association between implementation 
outcomes and patient subgroups, including race (white, Black/person of color), 
residence (rural, urban), and insurance status (private, Medicare, Medicaid, other, 
uninsured). For secondary, oncology financial navigator-level outcomes, generalized 
linear mixed models with random effect for within-oncology financial navigator repeated 
measurements will be used to estimate the number of and time to positive financial 
hardship screens addressed. SAS Version 9.4 will be used for data analysis. 
Table 3.  Patient data and sources. 
Sources 
Patient data 
Electronic 
medical 
record-
abstracted 
data 
Sociodemographics (age, race, sex, home 
address [to calculate socioeconomic proxies: 
Area Deprivation Index,39 Social Vulnerability 
Index40], insurance status) 
Clinical characteristics (cancer type, cancer 
stage, cancer diagnosis date, comorbidities) 
Patient-
reported 
data 
Financial distress (COmprehensive Score for 
financial Toxicity17) 
Financial difficulties (trouble paying for basic 
needs, utilities, transportation or lodging for 
treatment, medications, medical supplies, 
upfront medical payments, insurance or 
medical bills, child or eldercare, and 
employment or disability issues) 
Quality of life (PROMIS v1.1 Global Health30) 
Psychological distress (National 
Comprehensive Cancer Network Distress 
Thermometer31) 

8 
 
ii. Sample size: As Aim 1 is a secondary analysis of pragmatic, clinic-based, administrative 
data, these sample sizes are simply estimates dependent on implementation of oncology 
financial navigation within the UAB Medical Oncology clinic—there will be no true 
enrollment. As UAB is expecting to hire a minimum of 5 oncology financial navigators, 
our study will be powered on our primary analyses using patient-level data. UAB treats 
approximately 5,000 new patients with cancer per year. The UAB Cancer Service Line is 
planning to roll-out this service sequentially by cancer type, thus we anticipate ~1400 
patients targeted to receive oncology financial navigation per year during the first two 
years of roll-out. As oncology financial navigation is standard of care provided to all 
patients and thus an opt-out program, we anticipate that 90% of patients will be willing to 
receive oncology financial navigation if approached. Thus, we anticipate at least 2,500 
patients will receive oncology financial navigation over the 2-year duration of the funding 
period (n=1250/year). Under these assumptions, for patient-level analyses, the expected 
large sample size provides high power and precision to support our analysis of 
implementation outcomes.  
 
b. Aim 2. Evaluate oncology financial navigation effectiveness. 
i. Statistical analysis: To compare outcomes for patients receiving oncology financial 
navigation and historical controls (patients with financial hardship screening data from 
2020 to pre-oncology financial navigation implementation), we will use non-linear 
modeling (e.g. a Random Forest approach41) to estimate a propensity score to match 
navigated patients with historical controls using radius matching. If needed, we will use 
matching with replacement (i.e., a control patient could be matched with >1 patient 
receiving oncology financial navigation) to include as many patients receiving oncology 
financial navigation as possible. We will then use generalized linear or generalized linear 
mixed models to conduct between-group comparisons on financial and psychological 
outcomes. If matching with replacement is conducted, then cluster-level bootstrapping42 
(clusters indicated by the individual control patients) will be used to provide inference on 
these procedures. A False Discovery Rate approach will be used to correct for multiple 
inferences when appropriate (10% FDR). We will conduct sensitivity analyses to assess 
for changes in outcomes due to implementation strategies, local site changes, and 
national changes. SAS Version 9.4 will be used for data analysis. 
ii. Sample size: Given 800 historical controls with 6-month change scores, an estimated 
800 navigated patients with 6-month change scores, and assuming a two-sided t-test 
between change scores with ICC=0.5, we expect a detectable effect size d=0.14 at 80% 
power and α=0.025. Using our UAB Medical Oncology historical patient-reported 
financial hardship screening data, this effect size corresponds to a difference in mean 6-
month COST change scores of 1.5.   
 
c. Aim 3. Assess how implementation strategies were utilized to overcome barriers to 
oncology financial navigation. 
i. Qualitative data collection and analysis: Videocall-based interviews will elucidate 
oncology financial navigation (1) implementation barriers, and (2) perceptions of how 
selected implementation strategies addressed barriers (Table 1). Interviews will be 
conducted by Dr. Williams (PI) using interview guides developed in conjunction with Dr. 
Turan (co-mentor) and the larger mentorship team (GR, LZ). Interviews will be recorded 
and digitally transcribed. The analytic strategy will be primarily informed by content 
analysis, which classifies text into categories that represent key concepts within 
interviews.43 Qualitative coding and content analysis will consist of identifying quotations 
that express themes related to strategies utilized to overcome barriers to oncology 
financial navigation implementation. Two independent coders (CW, TP) will develop an 
initial open coding scheme, which is the process of labeling portions of text to identify all 
ideas and themes suggested by the data.44 Analytic codes constructed in the context of 
open coding are provisional and will be grounded within the data.45 The final version of 
the coding schema will be reviewed and finalized by the mentorship team (JT, GR, LZ). 
The two primary coders will then conduct “focused coding,” which includes a detailed 

9 
 
analysis of themes identified during open coding. Any discrepancies in coding will be 
discussed among the team and resolved. Dr. Rocque (primary mentor) has used this 
approach in prior studies and found it to be a useful strategy in evaluating program 
implementation.46-48 The process will be repeated until thematic saturation is reached, 
where no new categories or relevant themes emerge.49 Data from interviews will be 
analyzed at an aggregate and participant-specific level. Summaries will be reviewed with 
the mentorship team and used to understand implementation strategy effectiveness. 
DeDoose Version 9.0 will be used for qualitative analysis. 
ii. Sample size: Qualitative sampling is often sequential, targeted to individuals who can 
provide insights on the processes under study, and typically involves <50 participants.50 
If thematic saturation is not reached at a sample level, we will increase the number of 
participants until saturation is achieved. Access to a diverse group of participants will 
provide a sufficient participant pool to carry out analyses. If an unexpected perspective is 
observed within a specific patient subgroup, we will interview an additional 5 participants 
from the subgroup to conduct negative case analysis.51 
 
6. Data and Safety Monitoring  
This study is intentionally designed to be an evaluation of largely secondary health system data used in 
routine patient care. Best judgment is required of all oncology financial navigators in entering, 
interpreting, and/or acting upon information gathered from the patient-reported data. Therefore, a data 
safety and monitoring board is not necessary, but a data and safety monitoring plan is required. Prior to 
study initiation, University of Alabama at Birmingham Institutional Review Board (IRB) approval will be 
obtained.  
a. Aims 1&2: Data included in Aims 1&2 consist of electronic medical record (EMR)-abstracted 
sociodemographic and clinical data, EMR-embedded navigation software data, and EMR-
embedded patient-reported data. There will be no primary data collection from patients or 
oncology financial navigators for this quantitative portion of the study. Therefore, a waiver of 
consent will be requested for this portion of the study. Patient monitoring, including financial 
hardship screening data, will be conducted as part of standard of care. If an oncology financial 
navigator notices any indication of financial distress or reasons for concern, s/he will conduct 
timely follow-up with the patient in accordance with standard protocols. Data for implementation 
outcomes and patient outcomes are also collected as part of standard of care. Access to patient 
data will be limited to the patient care teams and relevant study staff. Data will be de-identified 
when possible and encrypted to enhance security. When unique patient identifiers (unrelated to 
any patient characteristics) are required to track patient-level outcomes, the files will be sent via 
secure transfer and stored on secure encrypted network drives. 
b. Aim 3: Qualitative interview data will be collected for Aim 3. All patient, provider, and health 
system participants will consent to study participation. All interview data from patient, provider, 
and health system interviews will be de-identified and securely stored on encrypted network 
drives at UAB. Access to interview data will be limited to the relevant study staff. Data will be 
de-identified when possible and encrypted to enhance security. 
 
7. Benefits 
Patients receiving standard-of-care oncology financial navigation may benefit by receiving support for 
cancer-related financial distress and/or difficulties.  
 
8. Potential Risks and Solutions 
a. Aims 1&2: Participants will not receive any clinical treatment as part of this study, minimizing 
physical risks. This project will utilize health and other personal information about the study 
participants. The primary risk to the participants will be loss of confidentiality leading to potential 
psychological, financial, or legal consequences. However, we believe the likelihood of 
confidentiality breach is very low.  
b. Aim 3: It is possible that some patients may be unwilling to participate in interviews due to 
embarrassment or concern about sharing responses regarding financial navigation; however, 
participation is entirely voluntary. For providers and health system participants, their choice to 
participate in interviews will not impact their employment in any way. Participants may also drop 

10 
 
out at any time, which will be indicated in the consent form. Interviews will be kept as brief as 
possible to minimize participant burden. If participants have any questions or concerns, the PI 
will address them in a sensitive and professional manner. 
 
9. Confidentiality 
a. Aims 1&2:  
i. All human subjects research described in this application will take place at UAB by 
investigators trained in the ethical conduct of human subjects research and in the use of 
protected health information. Protocols will be approved by the UAB IRB.  
ii. The PI and quantitative data manager will meet weekly to discuss any issues pertaining 
to data handling, protection, confidentiality, and to provide additional training as needed 
during these discussions.  
iii. Data will be protected for confidentiality as described in the Data Safety and Monitoring 
Plan. In previous experiences, the plans in place work well to protect against loss of 
confidentiality, and we anticipate they will continue to be effective. We will continue to 
review and update the plan as necessary, and we will maintain a work culture which 
stresses the importance of maintaining study participant confidentiality.  
b. Aim 3: 
i. Transcribed interviews will be de-identified and assigned a patient ID number. A list of 
assigned patient ID numbers will be kept on a password-protected UAB computer in a 
location different than where the transcribed files are stored. The videocall recording will 
be stored on an encrypted, password-protected computer at UAB. Names of persons, 
locations, and other personal identifying information will be replaced by generic codes 
following a coding scheme.  
ii. The PI and qualitative data manager will meet weekly to discuss any issues pertaining to 
data handling, protection, confidentiality, and to provide additional training as needed 
during these discussions.  
iii. Data will be protected for confidentiality as described in the Data Safety and Monitoring 
Plan. In previous experiences, the plans in place work well to protect against loss of 
confidentiality, and we anticipate they will continue to be effective. We will continue to 
review and update the plan as necessary, and we will maintain a work culture which 
stresses the importance of maintaining study participant confidentiality.  
 
10. References 
1. 
Altice CK, Banegas MP, Tucker-Seeley RD, Yabroff KR. Financial Hardships Experienced by Cancer 
Survivors: A Systematic Review. J Natl Cancer Inst. Feb 2017;109(2)doi:10.1093/jnci/djw205 
2. 
Hastert TA, Banegas MP, Hamel LM, et al. Race, financial hardship, and limiting care due to cost in a 
diverse cohort of cancer survivors. J Cancer Surviv. Jun 2019;13(3):429-437. doi:10.1007/s11764-019-00764-y 
3. 
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Program in Brain Cancer Patients. J Am Coll Radiol. Oct 2019;16(10):1420-1424. doi:10.1016/j.jacr.2019.07.014 
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navigators on patient out-of-pocket spending. Am J Manag Care. Mar 2018;24(5 Suppl):S74-S79.  
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Page 1 of 4 
Version 1 
10/07/2022 
CONSENT FORM TO BE PART OF A RESEARCH STUDY 
 
Title of Research: 
Evaluating the implementation and impact of standard-of-care 
delivered oncology financial navigation 
 
UAB IRB Protocol #: 
IRB-300012763 
 
Principal Investigator: 
Courtney P. Williams, DrPH 
 
Sponsor: 
UAB Department of Medicine Research Excellence 
Advancement and Mentorship (DREAM) Council 
 
General Information 
You are being asked to take part in a research study. This research 
study is voluntary, meaning you do not have to take part in it. The 
procedures, risks, and benefits are fully described further in the 
consent form. 
Purpose 
The purpose is to assess perceptions of how selected oncology 
financial navigation implementation strategies were used to address 
implementation barriers. 
Duration & Visits 
You will complete a 30-60-minute-long interview.  
Overview of 
Procedures 
Videocall-based interviews to understand oncology financial 
navigation (1) implementation barriers, and (2) perceptions of how 
selected implementation strategies addressed barriers. 
Risks 
The greatest risk is loss of confidentiality.   
Benefits 
None. 
Alternatives 
If you do not want to take part in the study, then your alternative is 
not to participate. 
 
Purpose of the Research Study 
We are asking you to take part in a research study. The purpose is to assess perceptions of 
how selected oncology financial navigation implementation strategies were used to address 
implementation barriers. This study will include patients who received oncology financial 
navigation, providers (oncology financial navigators, social workers, nurse managers, 
oncologists), and health system administrators (billing specialists, cancer service line 
leadership). We are planning to enroll approximately 20 patients, 10 providers, and 10 health 
system administrators from the University of Alabama at Birmingham (UAB). 
 
Study Participation & Procedures 
If you participate the study, you will also be asked to complete a 30-60-minute-long interview. 
During the interview, you will be asked questions about oncology financial navigation (1) 
implementation barriers, and (2) perceptions of how selected implementation strategies 
addressed barriers. This interview will take place over videocall. Your interview session will be 
audio-recorded, transcribed, and stored on secure and encrypted devices. 
 
Risks and Discomforts 
The greatest risk is breach of confidentiality. The study staff will protect your data so that your 
information will be kept private and will not release this information to anyone outside of authorized 
study personnel. The chance that this information will be given to someone outside of the 
authorized study personnel is very small. For patients, you do not have to answer any questions 
that you do not wish to answer as it may be uncomfortable talking and answering questions about 

Page 2 of 4 
Version 1 
10/07/2022 
your experience with oncology financial navigation. For providers and health system participants, 
your choice to participate in interviews will not impact your employment in any way. You may also 
drop out at any time. Interviews will be kept as brief as possible to minimize burden.  
 
Benefits 
Patients receiving standard-of-care oncology financial navigation may benefit by receiving 
support for cancer-related financial distress and/or difficulties. 
 
Alternatives 
Your alternative is not to participate in this study.  
 
Confidentiality and Authorization to Use and Disclose Information for Research Purposes 
Federal regulations give you certain rights related to your health information. These include the 
right to know who will be able to get the information and why they may be able to get it. The 
study scientist must get your authorization (permission) to use or give out any health information 
that might identify you. 
 
What protected health information may be used and/or given to others? 
All medical information, including but not limited to information and/or records of any diagnosis 
or treatment of disease or condition, which may include sexually transmitted diseases (e.g., HIV, 
etc.) or communicable diseases, drug/alcohol dependency, etc.; all personal identifiers, 
including but not limited to your name, social security number, medical record number, date of 
birth, dates of service, etc.; any past, present, and future history, examinations, laboratory 
results, imaging studies and reports and treatments of any kind, including but not limited to 
drug/alcohol treatment, psychiatric/psychological treatment; financial/billing information, 
including but not limited to copies of your medical bills; any other information related to or 
collected for use in the research study, regardless of whether the information was collected for 
research or non-research (e.g., treatment) purposes; records about any study drug you received 
or about study devices used; and consent forms from past studies that might be in your medical 
record. 
 
A description of this clinical trial will be available on www.ClinicalTrials.gov, as required by U.S. 
Law. This website will not include information that can identify you. At most, the website will 
include a summary of the results. You can search this website at any time. 
 
Who may use and give out information about you? 
Information about your health may be used and given to others by the study scientist and staff. 
They might see the research information during and after the study. 
• 
UAB staff involved with this research study 
 
Who might get this information? 
All individuals/entities listed in the informed consent document(s), including but not limited to, 
the scientists, physicians, nurses and staff and others performing services related to the 
research (whether at UAB or elsewhere). Your information may also be given to the sponsor of 
this research. “Sponsor” includes any persons or companies that are working for or with the 
sponsor, or are owned by the sponsor, or are providing support to the sponsor (e.g., contract 
research organization). 
 
Information about you and your health which might identify you may be given to: 
• 
the Office for Human Research Protections (OHRP) 
• 
the U.S. Food and Drug Administration (FDA) 

Page 3 of 4 
Version 1 
10/07/2022 
• 
Department of Health and Human Services (DHHS) agencies 
• 
Governmental agencies in other countries 
• 
Governmental agencies to whom certain diseases (reportable diseases) must be reported 
• 
the University of Alabama at Birmingham – the scientists, physicians, nurses and staff 
working on the research study (whether at UAB or elsewhere); other operating units of UAB, 
UAB Hospital, UAB Highlands Hospital, or University of Alabama Health Services 
Foundation, as necessary for their operations; the UAB IRB and its staff 
• 
the billing offices of UAB and UAB Health Systems affiliates and its billing agents 
 
Why will this information be used and/or given to others? 
Information about you and your health that might identify you may be given to others to carry out 
the research study. The sponsor will analyze and evaluate the results of the study. In addition, 
people from the sponsor and its consultants will be visiting the research site. They will follow 
how the study is done, and they will be reviewing your information for this purpose. 
 
What if I decide not to give permission to use and give out my health information? 
By signing this consent form, you are giving permission to use and give out the health 
information listed above for the purposes described above. If you refuse to give permission, you 
will not be able to be in this research. 
 
May I review or copy the information obtained from me or created about me? 
You have the right to review and copy your health information. However, if you decide to be in 
this study and sign this permission form, you will not be allowed to look at or copy your 
information until after the research is completed. 
 
May I withdraw or revoke (cancel) my permission? 
Yes, but this permission will not stop automatically. The use of your personal health information 
will continue until you cancel your permission. 
 
You may withdraw or take away your permission to use and disclose your health information at 
any time. You do this by sending written notice to the study scientist. If you withdraw your 
permission, you will not be able to continue being in this study. 
 
When you withdraw your permission, no new health information which might identify you will be 
gathered after that date. Information that has already been gathered may still be used and given 
to others. This would be done if it were necessary for the research to be reliable. 
 
Is my health information protected after it has been given to others? 
If you give permission to give your identifiable health information to a person or business, the 
information may no longer be protected. There is a risk that your information will be released to 
others, including others outside of UAB, without your permission. 
 
Voluntary Participation and Withdrawal 
Whether or not you take part in this study is your choice. There will be no penalty if you decide 
not to be in it. If you decide not to be in the study, you will not lose any benefits you are 
otherwise owed. 
 
You are free to withdraw from this study at any time. Your choice to leave the study will not 
affect your relationship with this institution. Contact the study scientist if you want to withdraw 
from the study. 

Page 4 of 4 
Version 1 
10/07/2022 
 
If you are a UAB student or employee, taking part in this research is not a part of your UAB 
class work or duties. You can refuse to enroll, or withdraw after enrolling at any time before the 
study is over, with no effect on your class standing, grades, or job at UAB. You will not be 
offered or receive any special consideration if you take part in this research. 
 
Cost of Participation 
There will be no cost to you for taking part in this study.  
 
Payment for Participation 
You will receive a $50 participation incentive. You will receive no other payment for your 
participation in the study. You are responsible for paying any state, federal, Social Security or 
other taxes on the payments you receive. You will receive a form 1099 in January of the year 
following your participation in this study. This form is also sent to the IRS to report any money 
paid to you. No taxes are kept from your payment. 
 
Questions 
If you have any questions, concerns, or complaints about the research. You may contact Dr. 
Courtney Williams by telephone at (205) 975-0462 or the study manager Ms. Stacey Ingram by 
telephone at (205) 934-5287. They will be glad to answer any of your questions. 
 
If you have questions about your rights as a research participant at UAB, or concerns or 
complaints about the research, you may contact the UAB Office of the IRB (OIRB) at (205) 934-
3789 or toll free at 1-855-860-3789. Regular hours for the OIRB are 8:00 a.m. to 5:00 p.m. CT, 
Monday through Friday. 
 
Legal Rights 
You are not waiving any of your legal rights by signing this consent form. 
 
Signatures 
Your signature below indicates that you have read (or been read) the information provided 
above and agree to participate in this study. You will receive a copy of this signed consent form. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Participant 
 
 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Person Obtaining Consent  
 
 
 
 
 
Date