Developing a Health Insurance Navigation Program for Survivors of Childhood Cancer
Phase: NA
Conditions: Health Insurance, Childhood Cancer Survivors
Sponsor: Massachusetts General Hospital

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Partners Human Research Committee 
Detailed Protocol 
 
TITLE: Understanding and Improving Health Insurance Coverage among Long-Term 
Follow-Up Study Cohort Participants 
PI: Elyse R. Park, PhD, MPH 
 
GRANT NUMBER: RSGI-18-135-01 - CPHPS 
VERSION DATE:  5/20/22 
I. BACKGROUND AND SIGNIFICANCE  
 
a. Historical Background 
Childhood Survivors are a growing population in need of medical surveillance. 
Children diagnosed with cancer have experienced improved survival rates over time, 
with more than three-fourths becoming long-term survivors.1 However, survivors of 
childhood cancer often face new and continued health care challenges and require 
ongoing care to monitor and treat long-term effects of their cancer and treatment 
throughout adulthood. Ongoing medical treatment and surveillance, with access to 
quality healthcare and coverage, are critical.   
Although quality health insurance coverage is critical to this population, it has 
been complex to obtain. Given their ongoing health care needs, obtaining and 
navigating health insurance coverage is vital to ensure access to needed survivorship 
care. However, this can be difficult for individuals with pre-existing conditions such as a 
cancer diagnosis, who have historically faced denials of coverage, steep premiums, or 
“job lock” that keeps them from changing jobs for fear of losing coverage.2,3 At the same 
time, childhood survivors have had higher rates of uninsurance, unmet health care 
needs, and burdensome costs.4-10 These survivors are also less likely than siblings to 
be employed, married, and have a higher household income.11-13 Dr. Park found that 
childhood survivors and siblings had similar rates of coverage, yet they differed by types 
of coverage and experiences obtaining coverage.4 Uninsured survivors in particular 
were more likely to experience financial burdens from medical care that affected their 
care utilization. 
Health care reform offers opportunities for childhood survivors to obtain quality 
coverage. The ACA14 was signed into law in 2010 and is intended to increase access to 
affordable, quality health care. ACA policies offer considerable opportunities for 
populations with pre-existing conditions like childhood survivors to obtain coverage and 
improve access to needed care. Dr. Park and colleagues delineated the implications of 
specific ACA provisions for insurance coverage for childhood survivors.15 

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Although the ACA has increased coverage rates, uninsurance and 
underinsurance may remain a problem for childhood survivors. The ACA and other 
unprecedented changes to the health care landscape offer both opportunities and risk to 
childhood survivors regarding insurance adequacy and underinsurance. From Dr. Park’s 
2011-2012 CCSS (Childhood Cancer Survivor Study) health insurance survey we found 
that childhood survivors lacked awareness about the ACA16 and had concerns that the 
ACA would increase their costs and threaten their quality and continuity of coverage.5, 
16,17  While the ACA requires coverage with no out-of-pocket costs for preventive 
services with “A” or “B” U.S. Preventive Services Task Force (USPSTF) ratings, these 
guidelines are not based on survivor-specific preventive guidelines and, as such, may 
not cover personalized screening recommendations.18 
 
Limitations in health insurance literacy can make choosing and using health 
insurance challenging. With the complex and confusing array of evolving insurance 
designs, being able to understand and navigate insurance benefits is crucial for 
survivors to obtain the health care they need. However, many people have inadequate 
understanding of available insurance benefits and resources, and have limited health 
insurance literacy (i.e. perceived knowledge, ability, and confidence to make informed 
decisions about choosing and using health insurance).19 Vulnerable populations, such 
as those with low income and poorer health, are more likely to have limited health 
insurance literacy.20-22 Understanding specific insurance benefits and larger ACA 
policies may help survivors maximize coverage and prevent unmet need and 
burdensome costs. 
 
Patient navigation interventions help patients overcome health care barriers. 
Patient navigation is a patient advocacy approach that was introduced in 1990, by Dr. 
Harold Freeman, to decrease high rates of breast cancer death among Black women in 
Harlem.28 Patient navigation aims to reduce cancer disparities and negative health 
outcomes among vulnerable patient populations. Patient navigators were envisioned as 
proactive patient advocates who provided logistic and emotional support to promote 
patients’ access to timely care.  
 
Existing navigator programs offer limited assistance with understanding and 
managing health insurance benefits and costs. The US healthcare system is 
complex. Even with reform under the ACA, understanding insurance options remains 
complicated and a source of frustration for consumers.24 While addressing insurance 
barriers to accessing care may be a component of some navigator programs, navigators 
focused specifically on helping patients understand and use their insurance benefits are 
rare. Navigator services mandated by the ACA in health insurance exchanges are 
available to help consumers choose and enroll in coverage, but their reach does not 
extend beyond enrollment. Many exchange enrollees have sought navigation services 
post-enrollment to help understand their new insurance plans, but such post-enrollment 
services are unavailable.25 At the same time, cost-sharing under the ACA will continue 
to increase as coverage was not stabilized by Congress via payments to insurers to 

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reduce costs for consumers. Survivors in particular are going to need comprehensive 
assistance with insurance in future years. 
 
b. Previous Studies 
Childhood survivors and health insurance. In 2005 Dr. Park published findings in the 
Journal of Clinical Oncology demonstrating that CCSS survivors, compared to siblings, 
were significantly more likely to be uninsured and have difficulties obtaining health 
insurance.4 In 2009-2010 she conducted in-depth interviews with a subset of CCSS 
survivors2,5 and with Drs. Kirchhoff, Donelan, and Kuhlthau found that survivors had low 
coverage expectations, had difficulties understanding how to utilize their coverage, and 
inevitably worried about future health care costs. This team surveyed a randomly 
selected sample of CCSS participants and siblings about their health insurance 
coverage and perspectives about the ACA.26,27 Survivors were significantly less likely to 
have employer-sponsored coverage (79.4% vs. 86.0%; p=0.04) and more likely to be 
covered by Medicaid/State (12.3% vs. 4.4%; p=0.002). 15.4% of survivors vs. 1.6% of 
siblings had recently been denied insurance (p<0.001). Survivors were more likely to 
borrow money to pay medical expenses (17.3% vs. 9.0% siblings; p=0.002) and not fill a 
prescription due to cost (15.7% vs. 9.0% siblings; p=0.02). Only 27.3% of survivors and 
26.2% of siblings reported familiarity with the ACA.  Concerns about the ACA included 
costs, decreased access to quality coverage, and employment. The majority of 
survivors, across different types of insurances, indicated strong interest in an insurance 
education program. 
 
Recent study team reports of childhood survivors’ underinsurance and its effects 
on financial burden and health care utilization. Dr. Kuhlthau led analyses describing 
patterns of health insurance coverage and care accessibility and affordability in an NHIS 
sample of adult childhood cancer survivors compared to adults without cancer during 
2010-2014. Significantly more childhood survivors reported being uninsured, delaying 
medical care (24.7% vs 13.0%), needing but not getting medical care (20.0% vs 10.0%), 
and having trouble paying medical bills (40.3% vs 19.7%), compared to controls 
(ps<0.0001).28 In 2017, Dr. Park and the study team published findings in JAMA Internal 
Medicine and JCO documenting that, compared to siblings, childhood survivors were 
significantly more likely to endorse indications of being underinsured, including being 
84% more likely to borrow money because of medical expenses, 80%more likely to 
worry about being unable to pay for a needed treatment, and 74% more likely to worry 
they wouldn’t be able to afford to fill a prescription. In addition, childhood survivors were 
more likely to report spending a higher percentage of their income on out-of-pocket 
medical costs. Survivors reported spending almost more than $1000 annual out-of-
pocket costs compared to siblings. A higher percentage of income spent on out-of-
pocket medical costs was significantly associated with survivors’ problems paying 
medical bills (OR, 8.9; 95% CI, 4.4 to 18.0); deferring care for a medical problem (OR, 
3.0; 95% CI, 1.6 to 5.9); skipping a test, treatment, or follow-up (OR, 2.1; 95% CI, 1.1 to 
4.0); and thoughts of filing for bankruptcy (OR, 6.6; 95% CI, 3.0 to 14.3).29,30  
 
Intervention and program development with childhood cancer survivors.  Dr. Park 
has studied the health behaviors and perceptions of childhood cancer survivors.31-34 

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She directed an NCI-funded trial to decrease smoking rates among 796 CCSS smokers 
that was found to be efficacious.31 She published a qualitative paper that had shaped 
the intervention,33 as well as a process evaluation paper which examined intervention 
characteristics associated with cessation success.32 Dr. Park also has extensive 
experience conducting qualitative research to inform survivorship program 
development.35-38 Dr. Kirchhoff is leading the development and testing of a childhood 
cancer survivor transition program with a focus on the provision of survivorship care 
plans for patients and families.39 
 
Health insurance and individuals with chronic conditions. Dr. Kuhlthau has 
extensive experience studying health insurance issues for individuals with chronic 
conditions, including Medicaid populations and groups with high expenditures.40-51 She 
has also studied unmet need, a commonly used measure of underinsurance.52-54 She 
conducted work on the private health insurance and work-life benefit systems for 
children with chronic conditions55,56 which resulted in guides for employers, families, and 
state employees. Dr. Galbraith’s work has demonstrated that children and families with 
chronic conditions are vulnerable to health insurance designs with high levels of cost-
sharing and may reduce use of needed care due to cost.57-59 Dr. Kirchhoff published on 
coverage gaps, financial burden, and medical costs, and their impact on access to care 
among childhood, adolescent and young adult cancer patients and survivors.60-62 
 
Effects of new insurance designs and health reform policies. Dr. Galbraith led one 
of the first studies of health insurance exchange plans, which documented problems for 
exchange enrollees with financial burden and unexpected costs;63 this study also 
identified challenges with understanding and choosing plans for families, many of whom 
wished for greater assistance navigating plan options.23 Dr. Galbraith has conducted 
studies of unmet health care need and financial burden among children and families 
with chronic conditions in high-deductible and other insurance plans.59, 64-66 She has 
examined the impact of increased cost-sharing on health care decision making and use 
of recommended health care services.67-72 She is conducting a trial to evaluate how a 
price transparency tool can help high-deductible plan enrollees manage costs. 
 
Peer counselor and navigator-based interventions. Dr. Park directed a smoking 
cessation trial, in collaboration with the Long-Term Follow-Up (LTFU) study at St. Jude 
Children’s Research Hospital, in which she trained childhood cancer survivors to be 
smoking cessation peer counselors and deliver a phone-based intervention.32 Dr. 
Galbraith conducted a randomized trial of a patient navigator intervention to reduce 
readmissions for high-risk patients discharged from a safety-net hospital.72,73 Dr. 
Donelan has conducted extensive survey research examining patient barriers to cancer 
screening and follow-up and physician referral communication with patients.74-77 She 
examined the effectiveness of a patient navigation program in improving minority 
patients’ follow-up of an abnormal mammogram. 
 
 
c. Rationale of Proposed Research 
 

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Health care reform under the Patient Protection and Affordable Care Act (ACA) offers 
considerable opportunities for childhood cancer survivors to obtain coverage and 
improve access to needed care.  However, in the general population, many people have 
low understanding of available insurance benefits and resources, and have limited 
health insurance literacy (i.e. perceived knowledge, ability, and confidence to make 
informed decisions about choosing and using health insurance). Misperceptions about 
which services require out-of-pocket costs may lead some enrollees to avoid services 
that are in fact exempt from cost sharing. Even with coverage protections from the ACA, 
barriers to obtaining quality coverage (e.g., in states without Medicaid expansion) and 
accessing needed care may remain for childhood survivors. Understanding and 
navigating insurance benefits is crucial for cancer survivors to obtain the health care 
they need. In this new post-reform landscape, the degree to which coverage and costs 
have changed for childhood cancer survivors is still largely unknown. 
 
d. Study Site Roles 
 
The sites in this study, MGH, St. Jude Children’s Research Hospital, and the University 
of Utah will each have different, complementary roles. The Partners IRB will be the IRB 
of record for this study, and the collaborating IRBs of St. Jude and the University of 
Utah will CEDE review to the Partners IRB. Site and IRB roles are described below.  
 
MGH Site Roles  
As the IRB of record and lead site for this study, MGH will be responsible for the 
development and regulation of all study-related materials, documents, assessments, 
and interventions. For Phase 1 of the study, MGH will be specifically responsible for the 
facilitation of advisory board and participant focus group interviews, and the qualitative 
analysis this data. Utilizing the data garnered from these interviews, MGH will further 
develop and tailor the intervention content (though MGH will work with collaborators on 
this aspect of the study, MGH will lead in the development and final submission of this 
piece).  
 
For Phase 2 of the study, MGH will be responsible for the delivery of the intervention 
content. Through the platform of MGH telehealth (Zoom), approximately 40 intervention 
arm participants (recruitment processes are described below) will receive brief health 
insurance educational sessions by a health insurance navigator. MGH will be 
responsible for the training and supervision of the navigator.  
 
For Phase 3 of the study, MGH will be responsible for the facilitation and analysis of exit 
interviews conducted with the Phase 2 intervention arm participants (MGH will not be 
conducting the exit interviews. See University of Utah Phase 3 roles for more 
information).  
 
St. Jude Site Roles  
As one of the collaborating sites for this study, St. Jude will be responsible for all 
recruitment activities. St. Jude Children’s Research Hospital is the site of the Long-Term 
Follow-up Study (LTFU), and study participants will be exclusively recruited from the 

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eligible members of this cohort. St. Jude will be responsible for recruiting, randomly 
selecting, and consenting participants for the focus group interviews, the open pilot of 
the study intervention, and the pilot randomized trial. Once recruited and consented, St. 
Jude will securely send relevant participant information to the study staff at the 
University of Utah and MGH.  
 
University of Utah Site Roles 
 As one of the collaborating sites for this study, the University of Utah will be responsible 
for all participant assessments during the study. During Phase 1 of the study, after 
receipt of participant information from St. Jude, the University of Utah will coordinate 
with MGH to set up and schedule participant focus groups. For the open pilot of the 
study, St. Jude will distribute baseline and follow up surveys to participants and will lead 
all quantitative analyses of these assessments. Lastly, the University of Utah will 
schedule and facilitate exit interviews with all open pilot participants and will securely 
send qualitative data to MGH for analysis. The University of Utah will also be 
responsible for remuneration of subjects during all phases of the study.  
 
For Phase 2 of the study, the University of Utah study roles mirror those of Phase 1, 
with the distribution of baseline and follow-up surveys to participants, and the collection 
and analysis of said data.  
 
For Phase 3 of the study, the University of Utah and MGH will coordinate to schedule 
exit interviews with the Phase 2 intervention arm participants. 
 
II. SPECIFIC AIMS 
Aim 1: To develop a psychoeducational health insurance navigation program 
(HINP). 
A1a: To qualitatively assess LTFU participants’ reports of 1) barriers to accessing 
and using quality health insurance2) resources to support health insurance access and 
use,  3) navigation program content, 4) intervention structure and dose,  5) program 
delivery, 6) program acceptability, 7) aspects of coverage that are not well understood 
A1b: Aim 1b: To qualitatively assess approximately  3 advisory boards’ and 
approximately 10 individual experts’ feedback 1) barriers, 2) resources, 3) content, 4) 
intervention structure and dose, 5) delivery and 6) selection criteria A1c: To pilot the 
intervention with LTFU participants (approximate n=10). 
 
Aim 2: To conduct a videoconferencing-based pilot randomized trial of the HINP 
(n= approximately 80). 
A2a: To assess the feasibility (number of eligibles enrolled and sessions 
completed) and acceptability (satisfaction, perceived support) of participants undergoing 
the HINP. 
A2b: At 3-month post-program follow-up, to assess the efficacy of the HINP to 
assist participants with accessing and utilizing coverage and managing costs. Primary 

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outcomes are 1) health insurance literacy and 2) financial distress related to medical 
costs 
A2b Hypothesis: The HINP, compared to enhanced usual care, will improve 
participants’ health insurance literacy and decrease financial distress. 
 
Aim 3: To refine the HINP program for future use. 
A3a: To explore HINP intervention arm participants’ 1) satisfaction with the 
intervention, 2) recommendations for modifications on delivery modality, and 3) 
recommendations for intervention topics and content modifications.   
 
Study Design Overview: The proposed study will take place in 3 phases and will 
involve a total of approximately 122 participants recruited from the Long-Term Follow-
Up (LTFU) study cohort (See Section III below)-  
 
• In Phase 1 we will develop a psychoeducational health insurance navigation 
program (HINP) through participant input and a series of advisory board 
meetings and individual interviews. We will also refine the program by recruiting 
a small group of LTFU study cohort members for an open pilot of the 
intervention.  
• In Phase 2 we will pilot the feasibility, acceptability, and preliminary efficacy of 
the videoconferencing-based HINP with LTFU study cohort members.  
• In Phase 3 we will further refine the program through study participant feedback. 
 
Below we describe the activities for the three study phases. Detail on participant 
enrollment and consent procedures for all three phases is included in Section IV. 
 
Phase 1 
Participant Focus Groups  
Four focus group interviews (approximately n=8 per group) will be conducted with 
randomly selected LTFU study participants (see Participant Focus Group Interview 
Guide); selection will be stratified according to Medicaid expansion status (Y/N), which 
we will determine based on participant demographic information from the LTFU data 
records. LFTU participants from the original and expansion cohort will be eligible and 
consented (Please refer to Sections III and IV for information on subject selection and 
consent procedures); we will assure inclusion of men and women.  Groups will last 
about 60 minutes, and may be conducted through Zoom, a HIPAA compliant 
videoconferencing platform (see Maintaining Confidentiality in Section VII) or in-person. 
Participants will be provided $50 remuneration by the University of Utah. Groups will be 
co-facilitated by co-investigators via a semi-structured interview guide (See Participant 
Focus Group Guide). The interviews will be recorded.  
 
Advisory Board Input on HINP 
Three advisory board meetings will be conducted, specifically, with national oncology 
clinicians and researchers and Boston-based experts. These groups will be co-
facilitated by investigators via a semi-structured interview guide that contains the 
following domains: 1) barriers, 2) resources, 3) content, 4) intervention structure and 

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dose, 5) delivery and 6) selection criteria (See Advisory Interview Board Guide). 
Advisory board meetings will also be conducted through Zoom Videoconferencing, via 
phone, or in person. The advisory board focus groups will be recorded and used for 
quality improvement purposes of the HINP.  
 
Expert Individual Interviews 
We will conduct approximately 10 30-minute individual interviews with experts at the 
intersection of health insurance, navigation, cancer, and survivorship. Experts will 
include clinicians, oncology social workers, and health insurance specialists. Interviews 
will be recorded and used for tailoring and improvement of the HINP. Individual 
interviews will be facilitated by investigators using a semi-structured interview guide 
containing the same domains as the advisory board interviews. These interviews will 
also be conducted through Zoom Videoconferencing via phone, or in-person.  
 
For both Advisory Board and Expert interviews, we will assent experts for participation 
in the interviews (See Advisory Board Interview Guide)  
 
Qualitative Analyses to Inform HINP Development  
For qualitative analyses of focus group, advisory board meetings, and individual 
interviews, all data will be analyzed by MGH and Utah study staff using NVivo 
qualitative software. Content analyses will be conducted including a structural thematic 
framework, categories, and coding plan. For focus group data, a coding framework will 
be developed for themes and codes according to participants’ feedback on 1) barriers to 
accessing and using health insurance 2) resources to support health insurance access 
and use,  3) navigation program content, 4) intervention structure and dose,  5) program 
delivery, 6) program acceptability, 7) aspects of coverage that are not well understood 
(See Participant Interview Guide) For advisory board and individual interview feedback, 
a coding framework will be developed for themes and codes according to the domains 
of: 1) barriers, 2) resources, 3) content, 4) intervention structure and dose, 5) delivery 
and 6) selection criteria. To ensure coding reliability, coding discrepancies for 
participant focus groups will be resolved through discussion and comparison of raw 
data. Coding will continue until a high level of reliability (Kappa= >0.80) is established. 
Co-investigators will provide an expert review of the results. For expert and advisory 
board interviews, a Rapid Analysis method will be used.   
 
Open Pilot with Participants  
With feedback from the focus groups, advisory boards, and individual interviews, results 
will be interpreted, summarized, and finalized; the investigators will refine the HINP. 
Then, approximately 5-10 participants will be randomly selected to participate as pilot 
subjects (Please see Sections III and IV for information on subject selection and 
consenting procedures). Aspects of the study that will be piloted include the surveys, 
intervention, and  exit interview. Participants will be remunerated $20 for the completion 
of a baseline survey,a follow-up survey and the exit interview by the University of Utah. 
Final intervention and survey modifications will be made. 
 
Phase 2  

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Pilot Trial Design  
We will recruit and randomize approximately 80 LTFU participants to a health insurance 
navigation intervention or to enhanced usual care (Please see Sections III and IV for 
information on subject selection and consenting procedures). We have selected this 
sample size of approximately 40 per arm to enable evaluation of feasibility and 
acceptability goals as well as explore meaningful differences in the outcomes.78 Surveys 
will be conducted at baseline and 3-month post program completion follow-up via 
REDCap or mail. All participants will be asked to complete a follow-up survey 
approximately 3-months after the HINP intervention period (in other words 
approximately 5-months post pilot trial enrollment).). After completion of the follow-up 
survey, HINP participants will be contacted for an exit interview (see Phase 3 below). 
Participants will be remunerated $20 for each survey and the exit interview by the 
University of Utah 
 
Study Arms 
 
Enhanced Usual Care  
Enhanced usual care will consist of a mailed or online copy of a health insurance 
resource guide.  
 
Navigation Intervention 
The intervention will be delivered via synchronous videoconferencing (real-time delivery 
and communication between the navigator and the participant) by a trained patient 
navigator (See Intervention Fidelity in Section VI) and will consist of 4, 30-minute 
sessions delivered every week, over the span of one month (for intervention 
development purposes, the pilot sessions will occur every week, over the course of one 
month). The navigation intervention group will also receive a mailed copy of the 
brochure.  
 
Proposed Navigation Intervention Structure and Content  
The program will be delivered via videoconferencing by a navigator over a 1-month 
period. Accordingly, patient navigation is delivered until the desired endpoint is 
achieved; we propose that this will be accomplished with 4 navigation sessions (See 
Table 1: Proposed HINP Intervention). The proposed program content was informed by: 
1) aforementioned research identifying childhood survivors’ difficulties with accessing 
and utilizing one’s coverage and managing costs, 2) CCSS health insurance survey, 
and 3) ACA provisions that are relevant to survivors (e.g., prevention services exempted 
from cost sharing, sources of available coverage and eligibility, benefits policies that 
have cost-related implications like OOP costs, and essential health benefits such as 
prescription medications. Based on advisory board and individual interview feedback, 
the content and tailoring of information will be modified. 
 
Table 1: Proposed HINP Intervention 
Session One: Learning About Survivorship Healthcare Needs  
Sessions Two: Learning About Your Plan in Relation to Policy 
Session Three: Navigating One's Own Plan 

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Session Four: Managing Care Costs 
 
 
Phase 3 
Exit Interviews 
For HINP participants after the follow-up survey, the study co-investigators  will conduct  
in-depth interviews (see Participant Exit Interview Guide) via videoconferencing with the 
40 intervention participants to assess survivors’ 1) satisfaction with the intervention, 2) 
recommendations for modifications on overall session topics and intervention content 
(e.g., physician communication, cost management strategies).  and 3) 
recommendations for modifications on delivery modality (e.g., number and length of 
sessions, videoconferencing delivery). These will last about 20 minutes and participants 
will be remunerated $20 for their time by the University of Utah. The exit interviews will 
be recorded.  
 
Exit interview data will be transcribed and analyzed using NVivo qualitative 
software. Content analyses will be conducted and co-investigators will provide an 
expert review. 
 
III. SUBJECT SELECTION  
Participants: Inclusion and Exclusion Criteria 
LTFU study staff at St. Judy Children’s Research Hospital keep updated participant 
contact records for this study, which allows for participants to be approached for 
additional research studies. For Phases 1 and 2, the LTFU study staff will recruit a total 
of approximately 122 participants from the Long-Term Follow-Up Study cohort.  
Phase 1 will involve recruitment of 32 participants for four focus groups and 
approximately 5-10 participants for the open pilot. Phase 1 participants will not be 
eligible for Phase 2 participation. For the focus group activities of this Phase, 
participants will be randomly selected stratified according to whether they reside in a 
state with or without Medicaid expansion, which LFTU staff will determine based on 
participant addresses available from the LTFU data records. 
Phase 2 will involve recruitment of 80 randomly-selected participants for the pilot 
randomized trial. Participants will be randomly selected stratified according to whether 
they reside in a state with or without Medicaid expansion, which LFTU staff will 
determine based on participant addresses available from the LTFU data records. 
Phase 3 participants will be recruited from the Intervention Arm of Phase 2 
(approximately n=40).  
For both Phases, we will exclude participants who : (1) do not have health insurance, 
(2) are under the age of 18, (3) are unable to give informed consent due to psychiatric 
or cognitive impairment as determined in consultation with study PI, patient navigator, or 
oncology social worker, and (4)  do not have access to an smartphone, computer or 
tablet with internet access. Importantly, we will closely document and monitor the 

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numbers of individuals who are unable to participate given this final criterion, as it will 
further inform the feasibility of this intervention modality. 
 
Sources of Subjects and Recruitment Methods 
The Long-Term Follow-Up Study (LTFU) is an NIH-funded multi-institutional study of 
individuals who were diagnosed before 21 years of age with leukemia, CNS 
malignancies, Hodgkin's disease, non-Hodgkin's lymphoma, Wilm’s tumor, 
neuroblastoma, soft tissue sarcoma, bone cancer or serious illness who survived at 
least five years after diagnosis. Eligible participants for the LTFU were identified through 
medical records and clinic lists at participating centers in the U.S., yielding a 
retrospectively ascertained cohort of adult childhood survivors with ongoing, longitudinal 
follow-up. The LTFU includes individuals diagnosed with cancer or serious illness 
between 1970-1999, recruited from over 25 pediatric oncology institutions in North 
America. Eligible participants for our study include 21,841 LTFU participants who are 
still alive and have available contact information.  
IV. SUBJECT ENROLLMENT  
Methods of Enrollment 
Prospective participants for each phase of the study from the LTFU study cohort will be 
identified via LTFU records and recruited and consented at the CCSS Coordinating 
Center at St. Jude Children’s Research Hospital (Supporting Facility for the LTFU) by 
LTFU staff. Prospective participants will receive an invitation to the study through email 
and mail (See LTFU Focus Group, Open Pilot, and Pilot Intervention Recruitment 
Letters). CCSS participants have consented to be contacted by the study and agreed to 
email communication by voluntarily providing us with their email address. St. Jude 
employs a system called Emma to administer and deliver email campaigns. Emma 
(myemma.com) is a secure email marketing platform that allows for multi-level 
campaigns with all or segments of our participants.  It allows for contact management, 
simple HTML template design with piping and logical integration, tracking of email 
campaign receipts, errors, and opt-outs, and drilling down to review participant level 
activity  If eligible and interested, prospective participants will read over an enclosed 
Research Consent Form, which they will have the option to either fill out via an online 
DatStat survey link (the system that St. Jude Children’s Research Hospital uses for 
LTFU consenting procedures, see Data Management in V. Study Procedures) or to fill 
out the hard copy of the form and mail it back to LTFU staff at St. Jude Children’s 
Research Hospital. Additionally, participants may also be recruited through telephone, 
with outreach being done by CCSS Coordinating Center, and a mailed version of the 
recruitment letter might be sent out, with instructions being provided for how to access 
the online consent portal. Potential participants will also be able to get more information 
about the study via a St. Jude website (which will also have a link to the online consent 
form). Following consent, the assignment of a unique study identification number to 
each participant, and randomization into intervention vs. control arms for Phase 2, 
participant information will be sent securely to Dr. Kirchhoff via SharePoint, an 
encrypted system used to transfer data. Dr. Kirchhoff’s team will lead the focus group 
scheduling and survey facilitation, while both MGH and University of Utah study staff will 

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coordinate the navigation intervention. The study interventionist may contact consented 
participants via telephone and email in to schedule intervention sessions.  
 
Informed Consent 
For the participant focus groups, open pilot, and pilot trial, informed consent will be 
facilitated by LTFU study staff using an IRB approved consent form for each piece of 
the study (See Focus Group, Open Pilot, and Pilot Intervention Consent Forms. The 
consent form will describe the study in detail, including the purpose of the research, 
clinical procedures, risks and discomforts, benefits, reimbursements, and alternatives to 
participation. Confidentiality, the right of each subject to request further information, and 
the right of each subject to withdraw from the study at any time, is fully detailed in each 
consent form. Patients will be informed via the consent form that they can freely choose 
not to participate. We will exclude participants who, as determined by the study PI or 
navigator, are unable to give consent due to psychiatric or cognitive impairment. There 
will be two separate consenting procedures for Phase 1 of the study. One consenting 
procedure will be for the focus group participants (n=32), and one consenting procedure 
will be for the open pilot participants (n=10). For Phase 2 of the study, there will be a 
single consent form for the pilot randomized trial participants (n=80). The intervention 
arm participants of Phase 2 (n=40) constitute the Phase 3 participants, so they will be 
consented for Phase 3 during the Phase 2 consent process. There will be separate 
consent forms that correspond to the described procedures.   
 
 
Intervention Assignment and Randomization 
 
Pilot Trial  
The CCSS Coordinating Center LTFU study staff will randomly select 80 participants 
among the LTFU cohort (original and expanded together). To do this, CCSS will use 
stratified random sampling, where we will divide the sample of LTFU participants into 
two groups: residing in a Medicaid expansion state or not. Random samples will then be 
selected from each of the two strata until 80 participants are consented and enrolled. 
The 80 selected participants will be randomized to either enhanced usual care (n=40), 
or the health insurance navigation intervention (n=40). After obtaining informed consent, 
participant information will be sent securely to Dr. Kirchhoff via SharePoint, an 
encrypted system used to transfer data. Dr. Kirchhoff’s team will lead the pilot trial 
procedures. 
V. STUDY PROCEDURES  
 
Recruitment and 
consent 
Scheduling 
activity 
Procedures 
Data - qualitative 
Data – 
quantitative  
Phase 1 
 
 
 
 
 
Focus 
groups 
LTFU staff 
identifies 
Medicaid vs. not 
Medicaid from 
LTFU records; 
Kirchhoff team 
receives 
consented list 
from LTFU via 
SharePoint; they 
set up FG time 
MGH runs FG via 
Zoom; records 
and transcribes 
the data 
Per grant -
Content analyses 
will be conducted 
by Drs. Park and 
None collected 

13 
 
Randomly selects 
and consents 
Goal: 4 FG x 8 
people -> 32 or so 
participants 
working with MGH 
team to schedule 
the research 
assistant 
 
Open 
pilot 
LTFU staff 
randomly selects 
& consents 
participants 
Goal: 5-10 
participants 
Kirchhoff team 
received 
consented list 
from LTFU via 
SharePoint; 
Kirchhoff team set 
up sessions with 
navigator 
Kirchhoff team 
collects baseline 
and FU surveys 
via REDCap 
 
Dr. Park and or/ 
study navigator 
and research 
assistant will 
conduct analyses  
Per grant - Dr. 
Kirchhoff will lead 
the analyses of 
surveys; will 
receive additional 
data from LTFU 
study as needed 
(demographics, 
etc) via 
SharePoint 
Phase 2 
 
 
 
 
 
Pilot 
LTFU staff 
identifies 
Medicaid vs. not 
Medicaid from 
LTFU records; 
Randomly 
selects; 
Randomizes 
Participants after 
they consent 
Goal: 80 
participants  
Kirchhoff team 
receives 
consented list 
from LTFU via 
Sharepoint;  
Kirchhoff team set 
up sessions with 
navigator 
Kirchhoff team 
collects baseline 
and FU surveys 
via REDCap 
None collected 
Per grant - Dr. 
Kirchhoff will lead 
the analyses of 
surveys; will 
receive additional 
data from LTFU 
study as needed 
(demographics, 
etc) via 
Sharepoint 
Phase 3 
 
 
 
 
 
Exit 
interviews 
No new 
recruitment 
Kirchhoff team will 
help schedule the 
interviews 
Exit interviews run 
by Utah team 
Content analyses 
will be conducted 
by Drs. Park and 
Galbraith 
None collected 
 
 
Data Management, Collection, and Transfer 
 
Recruitment  
During the recruitment periods of each phase of the study, St. Jude will track and obtain 
consent through DatStat, which allows researchers to configure online mobile 
responsive web surveys with tailored logic checks and requirements, data pre-
populating and piping, and portal access for quick reporting, analytics, and 
downloads.  The system is HIPAA compliant and fully validated for 21 CFR Part 11. 
Once participants are consented to the study, their information will be sent to Dr. 
Kirchhoff and her team at the Huntsman Cancer Institute at the University of Utah via 
SharePoint. SharePoint is a secure file sharing service supported by the Huntsman 
Cancer Institute that is encrypted and HIPAA certified. It is password protected and Dr. 

14 
 
Kirchhoff's SharePoint file sharing can only be accessed by other investigators through 
invitation to ensure data privacy. 
 
Quantitative Data 
For the pilot trial, Dr. Kirchhoff’s staff at the Huntsman Cancer Institute at the University 
of Utah will oversee the scheduling participants and will ensure the completion of the 
baseline survey and follow-up surveys for both Phase 1 and 2 of the study. Survey data 
will be collected via a secure web-based portal (REDCap). REDCap is maintained by 
the bioinformatics shared resource at the Huntsman Cancer Institute where Dr. 
Kirchhoff is an investigator. As such, she has access to survey and database support 
for REDCap for all data collection activities. Data transmissions will occur between Dr. 
Kirchhoff and the CCSS Coordinating Center and Statistics and Data Center via 
SharePoint to facilitate data access from the LTFU baseline and follow up surveys for 
inclusion in the statistical analysis (https://ccss.stjude.org/documents/original-cohort-
questionnaires). Dr. Kirchhoff will lead the pilot study survey data management and 
analyses, and transmit analytic data to MGH using SharePoint. Data will be managed 
and cleaned by Dr. Kirchhoff’s data manager and overseen by Dr. Kirchhoff. 
 
Focus Group and Exit Interview Qualitative Data  
Once the focus groups are scheduled by Dr. Kirchhoff’s team, the data collection efforts 
will be led via MGH’s Zoom program. The Phase 1 participant qualitative data will be 
collected and stored within MGH. Data will be collected by Dr. Park’s team at 
Massachusetts General Hospital using recording devices. Audio recording files will be 
saved and uploaded into NVIVO software on Shared File Areas in the Partners network, 
which will only be accessible to IRB-approved study staff.  NVIVO files will be sent 
securely via Partners Secure File Transfer or via SharePoint, which has been approved 
for use in this study. The Phase 3 qualitative data in the form of exit interviews will 
follow procedures detailed in Phase 1.  
 
Advisory Board and Expert Interview Qualitative Data  
After expert and advisory board interviews have taken place via Zoom, audio recordings 
will be stored on Shared File Areas in the Partners Network. Audio recordings will be 
directly uploaded into NVIVO and sent securely to study staff at the University of Utah 
for analysis. 
 
 
 
Intervention Arm Components 
Of the approximately 80 participants recruited for Phase 2 of the study, 40 will be 
randomized to enhanced usual care, and 40 will be randomized to the health insurance 
navigation intervention. As described above, the intervention arm will involve 4 sessions 
delivered by a navigator.  
 
Intervention Fidelity  

15 
 
The patient navigator (PN) will undergo training by the Co-investigators and pilot 
sessions. The NCI, with support from the ACS, established the Patient Navigation 
Research Program (PNRP) to implement and evaluate patient navigator programs. The 
PNRP developed a navigation performance checklist with 3 quality indicators of 
care:79,80 1) participant interaction (e.g., established rapport), 2) care management 
(assessed subjects’ understanding), and 3) intervention delivery (e.g., relevant 
information provided on insurance options, cost savings). Study investigators will review 
15% of patient navigation encounters using these quality indicator criteria. 
 
Assessments 
 
Phase 1 Assessments  
During the Open Pilot of the intervention, participants will complete a baseline survey 
and a 3-month post-program follow up survey. Participants will be remunerated $20 for 
the completion of each survey by the University of Utah. LTFU extracted medical record 
data will provide information on cancer diagnosis, age at diagnosis, years since 
diagnosis, and type of treatment. The open pilot will also involve an exit interview, which 
is described in further detail below.  
 
Phase 2 Assessments  
During the pilot trial, participants will complete a baseline survey, a 3-month post-
program follow up survey. LTFU extracted medical record data will provide information 
on cancer diagnosis, age at diagnosis, years since diagnosis, and type of treatment. 
 
Phase 3 Assessments  
After the completion of the follow-up survey, investigators will conduct In-depth exit 
interviews with the 40 intervention arm participants to assess participants’ 1) satisfaction 
with the intervention, 2) recommendations for modifications on overall session topics 
and intervention content (e.g., physician communication, cost management 
strategies)and 3) recommendations for modifications on delivery modality (e.g., number 
and length of sessions, videoconferencing delivery)  . Participants will be remunerated 
$20 for their time by the University of Utah.  
 
VI. BIOSTATISTICAL ANALYSIS  
Analysis Plan 
 
Qualitative Data 
For qualitative analyses of participant focus groups advisory board meetings, individual 
expert interviews, and exit interviews, all data will be analyzed by MGH and University 
of Utah study staff using NVivo qualitative software. For qualitative analysis of advisory 
board and individual expert interviews, audio files will be uploaded into NVIVO software 
and analyzed using a Rapid Analysis method. Content analyses for the participant focus 
groups an exit interviews will be conducted including a structural thematic framework, 
categories, and coding plan. For focus group data, a coding framework will be 
developed. To ensure coding reliability, coding discrepancies will be resolved through 

16 
 
discussion and comparison of raw data. Coding will continue until a high level of 
reliability (Kappa= >0.80) is established. Co-investigators will provide an expert review 
of the results.  
 
Focus Group Data: A coding framework will be developed for themes and codes 
according to participants’ feedback 1) barriers to accessing and using health insurance 
2) resources to support health insurance access and use, 3) navigation program 
content4) intervention structure and dose, 5) program delivery, 6) program acceptability, 
7) aspects of coverage that are not well understood 
Advisory Board and Individual Interview Data: A coding framework will be developed for 
themes and codes according to the advisory board feedback on 1) barriers, 2) 
resources, 3) content, 4) intervention structure and dose, 5) delivery and 6) selection 
criteria 
 
Exit Interview Data: A coding framework will be developed for themes and codes 
according to participants’ feedback on 1) satisfaction with the intervention, 2) 
recommendations for modifications on overall session topics and intervention content 
(e.g., physician communication, cost management strategies). and 3) recommendations 
for modifications on delivery modality (e.g., number and length of sessions, 
videoconferencing delivery)   
 
Quantitative Data  
For quantitative data, Dr. Kirchhoff’s team at HCI will conduct the analyses with input 
from Dr. Park and her study team, and the LTFU study team. As discussed in 
Participants, we will sample by Medicaid expansion vs. non-expansion states. All 
analyses will be weighted using inverse sampling probabilities so that results are 
representative of the overall LTFU study cohort.   
 
At baseline, all pilot participants will complete a baseline. The HINP navigator will use 
each participant’s baseline survey responses to personalize and individualize sessions.  
At the 3-month post-program follow-up, participants will complete the Phase 1 survey 
Outcome questions, which will be asked within the 5-month time frame period after trial 
enrollment. Participants will also be asked questions below about feasibility and 
acceptability. 
 
We will use descriptive statistics to report on the following endpoints: intervention 
feasibility (percent of participants enrolled), acceptability (satisfaction, perceived 
support) and efficacy (e.g., ACA familiarity, health insurance literacy, intention to adhere 
to recommended survivorship care, provider communication, and coverage status). 
Descriptive statistics will examine group differences at baseline; any imbalances will be 
adjusted. We will use chi square and independent t-tests to compare end-of-intervention 
changes in preliminary efficacy outcomes between the two groups. Although a 3-month 
post intervention follow-up period is brief, we will also conduct exploratory comparisons 
with other study outcomes to see if trends change in the expected direction. We will 
compare pre/end-of-treatment, within groups, with paired t-tests. In addition, we will use 
bivariate statistics to examine sociodemographic and cancer-related factors (type of 

17 
 
diagnosis, age at diagnosis, years since diagnosis, cancer treatment, chronic 
conditions81, cancer treatment (e.g., cranial radiation yes/no, anthracycline exposure 
yes/no) associated with feasibility, acceptability and preliminary efficacy outcomes. 
 
Outcomes 
Primary Outcomes: Feasibility and Acceptability.  
1. Feasibility: Number of eligible enrollees and number of sessions completed. 2. 
Acceptability: 4-point scales of satisfaction with navigation services (To what extent has 
this program met your needs? Did you get the kind of health insurance assistance that 
you wanted? How helpful has this program been for you?) and perceived support 
(emotional/informational scale of the Medical Outcomes Study social support survey, an 
8-item scale widely used with cancer patients).82-86 
 
Secondary Outcomes: Efficacy. 
 The ACS’s National Patient Navigator Leadership Summit recommend patient-
navigation outcome measures, which included: perceived knowledge, perceived 
confidence in overcoming barriers to care, and satisfaction with patient navigation 
services. Accordingly, we will measure: 1) health insurance literacy, 2) financial distress 
related to medical costs. 
3) familiarity with healthcare reform policies, 4) insurance status (among those insured 
at study enrollment), and 5) discussion with providers about health care costs63 and 
preventive services among those having a visit during this interval (2-item y/n 
questions). 
Measures 
To evaluate the pilot, we will use a mixed methods data collection approach, using both 
quantitative survey items and open-ended questions .87 Most study measures will come 
from survey questions repeated from the 2011-2012 CCSS health insurance survey 
(see Appendix); some new questions will be added and are indicated as such. Survey 
development included a qualitative study conducted with a sample of LTFU 
participants,5 modifications and inclusions of national survey questions87-92 and a 
cognitive testing phase. Using data collected previously by the overall LTFU via 
abstraction of medical records, data will be used to provide information on cancer 
diagnosis, age at diagnosis, and cancer treatment. These data will be provided to Dr. 
Kirchhoff’s team via SharePoint, an encrypted system used to transfer data. Data from 
the LTFU surveys will provide information on sociodemographic and medical history 
since cancer treatment, and presence of a medical late effects and chronic health 
conditions including second cancers. The measures will include the following:  
 
Participant Characteristic Measures (see study surveys) 
Characteristics: Age, Gender, Education, Race/Ethnicity, Partnership/Marital Status 
Enabling Characteristics: State of Residence, Familiarity with ACA Policies  

18 
 
Health Insurance Literacy: Confidence in Understanding of Terms (e.g. Coinsurance), 
Confidence in Choosing, Comparing, and Using Insurance, Household and Personal 
Income  
Need: Cancer Diagnosis, Age at Diagnosis, Years Since Diagnosis, Treatment Type, 
Recurrence of Primary Cancer, Second Malignancy, Other Chronic Conditions.  
Outcome Measures  
Insurance Coverage: Insurance Status, Difficulty or Denial in Obtaining Coverage due to 
Health History (within past 2 years), Difficulty Finding and Choosing a Plan  
Underinsurance: Not Taking a New Job in Order to Keep Health Insurance, Difficulty 
Finding a Provider who Accepts Insurance/ Not Able to Obtain an Appointment as 
Needed, Unmet Healthcare Need Due to Cost, Provider Visits in Past Year, or Out of 
Pocket Healthcare Costs, Out of Pocket Healthcare Costs/Premium Costs, Problems 
Due to Medical Expenses, Worry Related to Medical Costs  
Coverage-Related Variables: Current Coverage and Coverage History 
VII. RISKS AND DISCOMFORTS  
Psychological Risks 
Individuals may find it stressful to answer questions about their experiences with health 
insurance coverage and care. The risks associated with these discussions are minimal, 
and do not rise above the level of harm encountered during daily activities.  
The potential risks to subject include: 1) Discussing health insurance coverage and care 
and participating in a program to discuss these issues with the navigator and the patient 
navigator has the potential for increasing psychological vulnerability. 
These risks will be described by the patient navigator and be clearly outlined in the 
consent form. Participants will be encouraged to discuss any concerns with the patient 
navigator. In the event of a psychiatric emergency, confidentiality may be suspended. If 
the patient navigator notes severe distress, Dr. Park will contact the participant to 
assess for safety and report concerns as soon as possible to the LTFU PI, Dr. Greg 
Armstrong, and the LTFU Project Director, Dr. Aaron McDonald, at St. Jude Children’s 
Research Hospital. Participants will be informed of the limits of confidentiality at the 
beginning of the study.   
Procedures for Minimizing Risk 
Every effort will be made to minimize the study burden. The time commitment will be 
explained to all participants prior to the focus groups and pilot trial study consent. Every 
effort will be made to minimize the length and maximize the convenience or the pilot 
surveys completion.  
 
Maintaining Confidentiality 

19 
 
There is a low risk that protected health information could be impermissibly disclosed or 
that the confidentiality of patient information may be breached. Stringent guidelines are 
established in order to assure the confidentiality of study subjects. A unique study 
identification number will serve as the primary identifier for study participants. Personal 
identifiers will not be part of the computerized data record. Names and addresses will 
be maintained in a password protected restricted data file accessible only to the 
principal investigator, study coordinator and designated personnel within the Data 
Coordinating Center. A hard copy of names and corresponding study ID numbers will be 
kept in a locked file cabinet within the CCSS Coordinating Center. The computerized file 
will only be used for generation of correspondence with the study subject. Personal 
identifiers will be removed from all survey booklets following completion of initial editing 
and scanning. Similarly, names will be removed from all LTFU abstracted information. 
Study participants are informed of the potential risks and benefits regarding the security 
of their personal information. MGH TeleHealth enables connection through virtual 
HIPAA-compliant videoconferencing technology including: phone, video, text, email, 
mobile applications and remote monitoring. These virtual visits are conducted via a 
Zoom videoconference platform. Zoom has been approved for use in this study by RISO 
review.  
 
VII. POTENTIAL BENEFITS 
The consent form for the overall LTFU study enrollment clearly states that there may be 
no direct benefit to the participants from study participation. For the pilot trial phase of 
the proposed study, participants in both groups will be given information that could 
improve their ability to access affordable coverage. Participants in the intervention 
group will also receive navigation support, for up to 4 phone-delivered sessions. As an 
alternative to the intervention, participants may explore health insurance support options 
at their current primary care center. 
 
IX. MONITORING AND QUALITY ASSURANCE 
 
Training of all Study Personnel in the Responsible Conduct of Human Studies 
Prior to recruiting subjects or handling study data, all study personnel will be required to 
pass an NIH-approved course that reviews regulatory and informational documents on 
human subject protection and the responsible conduct of human studies. In addition, all 
study personnel will sign a statement of commitment to the protection of the rights and 
welfare of human subjects participating in research. In addition, all study staff must 
complete and submit Conflict of Interest (COI) Disclosure forms to their respective 
institutions. 
 
Data Monitoring Plan  
Survey data will be collected via Dr. Kirchhoff’s team at the Huntsman Cancer Institute. 
Data will be collected via mailed/phone-based survey and through a secure web-based 
portal (REDCap). Data transmissions will be conducted between the CCSS coordinating 

20 
 
center and statistical center with Dr. Kirchhoff to generate the participant sample and to 
facilitate data access from the LTFU baseline and follow up surveys. While the majority 
of surveys will be done via web using REDCap, we will allow participants to complete 
the baseline and follow-up surveys through mail or phone to improve participation. To 
ensure security, participant data collected using paper and pencil records will be stored 
in a locked filing cabinet in a locked room at the Huntsman Cancer Institute at the 
University of Utah; electronic participant tracking databases will be stored on a secure 
server accessible only by IRB-approved members of Dr. Kirchhoff’s study staff. Data 
collected on paper and pencil forms or through phone-based surveys will be thoroughly 
cleaned and entered into the electronic REDCap database with a 10% check; 
discrepancies will be resolved by Dr. Kirchhoff. Dr. Kirchhoff will lead the pilot study 
data management and analyses, and transmit analytic data to MGH using the Hartwell 
Center's FTA protocol (located at http://fta.stjude.org), which is a web-based interface 
with a secure 128-bit encrypted web connection. Only study staff will have access to the 
study data on Shared File Areas. Data quality (including sessions participated in for the 
intervention group, data missingness, and recruitment rates) will be monitored monthly. 
Interim data analysis will be conducted throughout the trial and results will be reported 
in the annual ACS progress report.  
 
Adverse Events Reporting 
Serious adverse events will be reported to Drs. Park and McDonald (LTFU PI) 
immediately. Dr. Park will be responsible for the reporting of any adverse events to the 
Massachusetts General Hospital Institutional Review Board. The MGH IRB requires that 
serious adverse events are to be reported to the IRB as soon as possible, but no later 
than 10 working days from the date on which the investigator became aware of the 
event. Non-serious adverse events are to be reported within 20 working days. The St. 
Jude IRB reviews reports of unanticipated events involving risks to participants and 
others. The level and rapidity of review will depend upon factors such as the 
seriousness of the event. 
 
 
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24 
 
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