A Virtual Health Insurance Navigation for Colorectal Survivors
Phase: NA
Conditions: Health Insurance, Colorectal Cancer Survivors
Sponsor: Massachusetts General Hospital

 
Version 2021.12.22 
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Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
 
Principal Investigator: 
Elyse R. Park, PhD, MPH 
 
Project Title: 
Using a Virtual Health Insurance Navigation Program to Understand and 
Improve Health Insurance Coverage 
 
Version Date: 
1/29/25 
 
 
For Intervention/Interaction studies, submit a Detailed Protocol that includes the following sections.  If 
information in a particular section is not applicable, omit and include the other relevant information.   
 
1. Background and Significance 
 
Colorectal Cancer in the United States 
Rates of colorectal cancer, particularly for those under the age of 50 have been increasing.1 This trend 
will likely lead to an increase in the number of survivors of colorectal cancer, due to relatively high 
survival rates.2 Interventions are needed to ensure the health and wellbeing of this growing population, 
particularly around the areas of health insurance, financial burden, and cancer surveillance and follow-
up care.  
 
Health Insurance Specifics and Financial Burden Among Cancer Survivors. Cancer survivors experience 
a high degree of financial burden related to medical care, particularly in relation to health insurance. 
Such financial burden impacts the health-related quality of life of cancer survivors.3 Cancer survivors 
with high deductible insurance plans, for instance, tend to postpone or go without medical care, have 
higher financial barriers to care access, and skipping or taking less medication.4-7 Additionally, survivors 
and their partners often make employment decisions that are motivated by the need to maintain health 
insurance, pointing to the importance of the relationship between medical cost, financial burden, and 
health insurance in this population.8 
  
Financial Burden and Health Insurance Among Survivors of Colorectal Cancer. Patients diagnosed with 
colorectal cancer have a higher risk of experiencing financial burden related to health care costs when 
compared to patients diagnosed with other typed of cancer.9 While many cancer survivors report 
experiencing financial burden3,8, financial burden is particularly acute among survivors of colorectal 
cancer.10,11 Outcomes of financial burden among colorectal cancer survivors include lower health related 
quality of life, employment concerns, and delay or lack of engagement in needed surveillance and 
follow-up care.10-12 Type of health insurance, which may be related to offsetting of burdensome medical 
costs, has been shown to be related to engagement in follow-up and surveillance care among colorectal 
cancer survivors.13 Private health insurance, for instance, has been shown to be a protective factor for 
receipt of surveillance care among colorectal cancer survivors. Low health insurance literacy has also 
been linked with a higher degree of financial burden among colorectal cancer survivors.14 This obligates 
practitioners and interventions to target health insurance literacy among this population to reduce 
financial burden and improve adherence to needed cancer surveillance and follow-up care.  

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Previous Study 
In 2018, the American Cancer Society funded a project to develop and pilot a health insurance 
navigation intervention with childhood cancer survivors from the Childhood Cancer Survivor Study 
(Protocol # 2018P003088- “Understanding and Improving the Health Insurance Coverage Among Long 
Term Follow-up Study Cohort Participants”. The present study builds on the project to adapt the 
intervention for adult survivors of colorectal cancer.  
 
Rationale of Proposed Research 
Health care reform under the Patient Protection and Affordable Care Act (ACA) offers considerable 
opportunities for colorectal 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).15 Misperceptions 
about which services require out-of-pocket costs may lead some enrollees to avoid services that are in 
fact exempt from cost sharing. For colorectal cancer survivors are particularly vulnerable to financial 
burden related to low health insurance literacy.14 For colorectal cancer survivors, having a proficient 
understanding of health insurance is necessary for obtaining adequate health insurance to meet follow-
up and surveillance needs without experiencing a significant degree of financial burden 
 
2. Specific Aims and Objectives  
 
Aim 1: To conduct an open pilot of a videoconferencing-based randomized trial of the health 
insurance navigation tools program with approximately 5 colorectal cancer survivors. 
A1a: To assess the preliminary feasibility and acceptability of the HINT intervention via the measures 
and methods described below  
A1b: To utilize open pilot feasibility and acceptability data to inform Aim 2 (RCT) methodology 
 
Aim 2: To conduct a videoconferencing-based randomized trial of the health insurance navigation 
tools program (HINT) (n= approximately 60). 
A2a: To assess the feasibility (number of eligible enrolled and sessions completed) and acceptability 
(satisfaction, perceived support) of participants undergoing a health insurance navigation tools program 
(HINT). 
A2b: At 3-month post-program follow-up, to assess the efficacy of the HINT to assist participants with 
accessing and utilizing coverage and managing costs. Primary outcomes are 1) health insurance literacy 
and 2) financial distress related to medical costs. A2b Hypothesis: The HINT, compared to enhanced 
usual care, will improve participants’ health insurance literacy and decrease financial distress. 
 
3. General Description of Study Design 
 
Open Pilot Design: We will recruit approximately 5 colorectal cancer survivors from Massachusetts 
General Hospital via the Research Patient Data Registry (RDPR) to take part in a health insurance 
navigation intervention. Recruitment, consent, and intervention approach for the pilot will mirror the 
trial design, as described below. The purpose of the open pilot is to inform any changes in the trial and 
program approach prior to implementing the randomized pilot trial.   
 

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Randomized Trial Design: We will recruit and randomize approximately 60 colorectal cancer survivors 
from Massachusetts General Hospital via the Research Patient Data Registry (RDPR) 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 HINT intervention period (in other words approximately 5-
months post pilot trial enrollment). Participants will be remunerated $20 for each survey. 
 
Study Arms 
 
Enhanced Usual Care  
Enhanced usual care will consist of a mailed or emailed copy of a health insurance booklet.  
 
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 5, approximately 30-minute sessions 
delivered every week or two, over the span of approximately one month (See Table 1: Proposed 
HINP Intervention). The sessions will occur one-on-one between the navigator and the 
participant and will be interactive (i.e. participants will be able to ask questions and respond to 
content throughout the sessions). The proposed program content was informed by the 
following: 1) aforementioned research on the associations between financial burden and health 
insurance literacy among colorectal cancer survivors, 2) CCSS health insurance survey, 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), and 4) an 
ongoing randomized pilot trial of the program with survivors of childhood cancer. The 
navigation intervention group will also receive a mailed copy of the health insurance booklet 
given to the enhanced usual care arm. 
 
Table 1: Proposed HINT 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 
Session Four: Managing Care Costs 
 
4. Subject Selection 
 
Participants: Inclusion and Exclusion Criteria 
Study participants will be identified via the online query tool of the RDPR for both the open pilot and 
randomized trial. Patients who are 1) approximately 6 months to 5 years posttreatment for stages I-III 
colon or rectal cancer or 2) approximately more than 3 months post-diagnosis for stage IV colon or 
rectal cancer at the time of screening will be eligible.  We will constrain records to patients who have (a) 
had a medical visit at a MGH Cancer Center (ie. MGH Boston, Danvers, Waltham or Mass General Cancer 
Center at Newton-Wellesley) in the past two years, (b) an ICD diagnostic code of colorectal cancer (i.e., 

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malignant neoplasm of the colon, rectum, or rectosigmoid junction), and (c) a pathology report with the 
terms “stage I”, “stage one”, “stage II, “stage two”, “stage III” or “stage three”. 
 
Records include patient’s medical record numbers, demographic characteristics, diagnoses (code and 
encounter date), inpatient and outpatient encounters, and other medical care. Approximately 65 (5 for 
the open pilot, 60 for the RCT) participants meeting these criteria will be identified and recruited. We 
will exclude participants who: (1) do not speak English, (2) do not have health insurance, (3) are under 
the age of 18, (4) are over the age of 65, (5) are unable to give informed consent due to psychiatric, 
cognitive, or medical (ie. Patient in hospice at end of life) impairment as determined in consultation with 
study PI, patient navigator, or oncology social worker, and (6) do not have access to a smartphone, 
computer or tablet with internet access. The rationale for the third exclusion criterion is that an 
intervention with a large number of Medicaid-eligible survivors would be outside the scope of the 
current intervention. The rationale for the fifth exclusion criterion is that the health insurance navigation 
intervention is delivered via an MGB-approved video-conferencing system (ie. Zoom).  
 
A member of the research team will review the electronic medical record (i.e., EPIC) to ensure that 
identified patients are eligible for the study before proceeding with outreach. A team member will 
confirm that the patient is alive and has not been hospitalized within the past year due to psychiatric 
reasons.   
 
Sources of Subjects and Recruitment Methods 
The Research Patient Data Registry is a centralized clinical data registry that stores and gathers patient 
information from across the Mass General Brigham system. It provides clinical researchers the ability to 
perform population queries and identify target subpopulations for research studies.  Research Options 
Direct to You [RODY] patients and self-referred within the RDPR will be contacted about the study.  
 
5. Subject Enrollment 
 
Methods of Enrollment 
Potential participants will be identified via the Mass General Brigham RDPR. Patients among the 
Research Options Direct to You (RODY) designation within the RDPR will receive an opt-out letter from 
the study team. This letter (See Recruitment Letters) will describe the study procedures and ask patients 
to contact the study team within 3 days if they would not like to be contacted further about the study. 
Those who do not opt-out will be contacted via encrypted email or by phone by the PI or by a trained 
and CITI-certified research staff member, and they will be read or sent a brief description of the study 
(See Study Description Documents). 
 
Patients may also express interest in the study by contacting the research team directly.  
 
Patients who are interested will be screened for eligibility, and those who are eligible will undergo 
informed consent. Specifically, eligible and interested patients will be asked to review the study fact 
sheet by phone with a study team member. Once that is completed, the study fact sheet will be sent to 
participants in an encrypted / unencrypted email, depending on their preference (see HINT C Short 
Consent). This method of obtaining consent has been used in other IRB-approved trials, like 
2018P000539). Following consent, enrollees will be assigned a unique study identification number and 
will complete a baseline assessment. Patients who consent and complete the baseline assessment will 
then be randomized into the intervention or control arm.  

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The study interventionist will contact consented participants randomized to the intervention via 
unencrypted or encrypted email to schedule the HINT sessions, again depending on patient preference. 
To facilitate communication with the oncology team, the interventionist will complete a summary 
documentation note within EPIC informing clinicians of the patients’ participation in the program. We 
will send reminder notices via calls, emails, mail, and Patient Gateway for participants who have not 
completed the baseline survey or for those in the intervention arm who have not scheduled their 
sessions, as needed (see “HINT C Difficult to Reach Letter”).  
 
Privacy protection: To address security issues related to email communication, participants will be 
informed about security in the opt-out letter itself via inclusion of the following text:  
 
“Please note that emails sent to the study staff from your personal email address may not be secure and 
could result in the unauthorized use or disclosure of your information. If you want to email the study 
team despite these risks, Partners HealthCare will not be held responsible. If you do not want to email 
the study team, you may instead call [XXX RA’s phone number]”.  
 
For any emails sent by the study team, they will be encrypted using Send Secure unless patients verbally 
agree to receive unencrypted email, which we will document. Patients will receive the following 
information:  
 
“The Partners HealthCare standard is to send email securely. This requires you to initially set up and 
activate an account with a password. You can then use the password to access secure emails sent to you 
from Partners HealthCare.  If you prefer, we can send you “unencrypted” email that is not secure and 
could result in the unauthorized use or disclosure of your information. If you want to receive 
communications by unencrypted email despite these risks, Partners HealthCare will not be held 
responsible. Your preference to receive unencrypted email will apply to research studies for emails sent 
to you from research staff in this study. If you wish to communicate with other research staff at Partners 
regarding additional studies, your preference will have to be documented with each research group." 
 
Informed Consent 
Eligible and interested patients will be asked to review the study fact sheet by phone with a study team 
member. Once that is completed, the study fact sheet will be sent to participants in an encrypted / 
unencrypted email, depending on their preference (see HINT C Short Consent). This method of obtaining 
consent has been used in other IRB-approved trials, like 2018P000539).  
 
Intervention Assignment and Randomization 
Using the RDPR, MGH staff will outreach to patients meeting the eligibility criteria and query terms. For 
the randomized pilot trial, the 60 participants will be randomized to either enhanced usual care (n=40), 
or the health insurance navigation intervention (n=40). Randomization will employ a random plan 
generator, with consented patients being randomly assigned to either the enhanced usual care or the 
health insurance navigation intervention, stratified by age (18-39 and 40-65). 
 
6. Study Procedures 
 
Navigation Intervention 

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After baseline survey completion, consented intervention arm participants will be contacted by the 
health insurance navigator to schedule their health insurance navigation sessions. The sessions will 
occur weekly or every other week, depending on participant availability. The health insurance navigator 
will utilize encrypted email (unless the participant agrees to communicate via unencrypted email) and 
phone calls to schedule health insurance navigation sessions. The navigator may also use a Partners 
approved text messaging service to contact patients who have agreed to be sent text messages during 
the consent process, which will be utilized for session reminders.  
 
Upon completion of the intervention, the interventionist will document within EPIC the number of 
sessions a participant attended so that the clinicians may be aware of their patients’ participation.  
 
Data Management, Collection, and Transfer 
 
 
Recruitment  
The RDPR allows for HIPAA-compliant recruitment and contact of potential research subjects. 
Participants will be contacted securely via encrypted recruitment emails. If patients consent to 
enroll in the study, the patient’s RDPR information (e.g., demographics, health insurance type) will 
be imported into a REDCap database, which is a secure-web based portal housed within the Mass 
General Brigham fire wall. Other information pertaining participant recruitment will be stored on 
password-protected excel spreadsheets within Secure File Areas, which will only be accessible to 
study team members.  
 
 
Assessments 
All study participants will complete a baseline survey and a follow up survey approximately 3 
months post-program completion. Participants will be remunerated $20 for the completion of each 
survey. MGH extracted medical record data will provide information on sociodemographics and 
cancer history (e.g., cancer diagnosis, age at diagnosis, and type of treatment). These data will be 
extracted from EPIC records by CITI and EPIC-trained study staff after participant consent.  
 
 
Quantitative Data 
MGH study staff will oversee the scheduling participants to health insurance navigation sessions and 
will ensure completion of the baseline survey and follow-up surveys. Survey data will be collected 
via a secure web-based portal (REDCap). Research Electronic Data Capture (REDCap) is a web-based 
platform that allows for HIPAA-compliant storage of protected health information.16 RCT 
participants will complete the study measures.  
 
Intervention Fidelity  
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:17,18 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 approximately 15% of patient navigation 
encounters using these quality indicator criteria. Navigation sessions will be recorded following patient 
assent to facilitate these fidelity assessments. The recordings will be audio and not video.  
 
Measures 

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To evaluate the pilot, we will use a mixed methods data collection approach, using both quantitative 
survey items and open-ended questions.26 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 modifications and inclusions of national 
survey questions26-32 and a cognitive testing phase. Using data collected previously by the RDPR via 
abstraction of medical records, data will be used to provide information on cancer diagnosis, age at 
diagnosis, and cancer treatment. Data from the RDPR 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 (From RPDR and/or study surveys) 
Characteristics: Age, Gender, Education, Race/Ethnicity, Partnership/Marital Status 
Enabling Characteristics: Zip Code, Familiarity with ACA Policies  
Health Insurance Literacy: Likert scale assessments of- Confidence in Understanding of Terms (e.g. 
Coinsurance), Confidence in Choosing, Comparing, and Using Insurance, Household and Personal 
Income  
Cancer Diagnosis, Treatment Type  
 
Outcome Measures  
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).20-24 
 
Secondary Outcomes: Efficacy. 
 The ACS’s National Patient Navigator Leadership Summit recommend patient-navigation outcome 
measures, which include: 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 costs24 and preventive services among those having a visit during this 
interval (2-item y/n questions). 
 
Secondary Outcomes: Program Satisfaction.  
Program satisfaction outcomes will include Likert scale (very poor, poor, average, good, excellent) 
on items including communication with the navigator, scheduling convenience, number of sessions, 
length of sessions, the health insurance booklet, the overall quality of the program. Satisfaction with 
the virtual format delivery of the program will also be assessed on a Likert scale, and will include 
items on the MGB-approved video-conferencing system (ie. Zoom) and the material presented via 
PowerPoint during the navigation sessions. We will also assess likelihood of program 
recommendation for other colorectal cancer survivors (definitely would recommend, probably 
would recommend, neutral, probably would not recommend, definitely would not recommend). 
Program helpfulness will be assessed on a 1-10 scale. Lastly, open ended questions will be asked 
about helpfulness of the program and aspects of improve upon. Program satisfaction questions will 
be asked only of intervention arm participants. 

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7. 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) Answering questions about or 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 
MGB IRB.  
 
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 
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 study personnel. Similarly, names 
will be removed from all RDPR abstracted information. Study participants are informed of the potential 
risks and benefits regarding the security of their personal information. Utilizing an MGB-approved video-
conferencing system (ie. Zoom) enables connection through virtual HIPAA-compliant videoconferencing 
technology. The virtual visits will be conducted via MGB-approved video-conferencing system (ie. 
Zoom).  
 
 
8. Benefits 
 
The consent form states that there may be no direct benefit to the participants from study participation. 
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 5 video-
based sessions. As an alternative to the intervention, participants may explore health insurance support 
options at their current primary care center. 
 
9. Statistical Analysis 
 
Dr. Kirchhoff, and the study team at University of Utah will complete the analyses. The team 
will be blinded to treatment allocation until trial analyses completion. Dr. Kirchhoff’s team will 
receive de-identified study data. 

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Open Pilot  
Pilot data is meant to inform and test the function of the study procedures, so no formal analyses 
will be performed. We will use preliminary feasibility and acceptability data (as outlined below) to 
inform necessary changes to our approach.  
 
Randomized Trial  
 
Quantitative Data  
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 (e.g., type of diagnosis, age at diagnosis, cancer treatment18, cancer 
treatment (e.g., cranial radiation yes/no, anthracycline exposure yes/no) associated with 
feasibility, acceptability and preliminary efficacy outcomes. 
 
10. 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. Park’s study team at the Health Policy Research Center. Data will be 
collected via mailed/phone-based survey and through a secure web-based portal (REDCap). Electronic 
participant tracking databases will be stored on a secure server (Shared File Area) accessible only by IRB-
approved members of Dr. Park’s study staff. 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 Dr. Park by study staff 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 

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11. Select the Privacy and Confidentiality measures that apply to this research: 
☒ Study procedures will be conducted in a private setting 
☒ Only data and/or specimens necessary for the conduct of the study will be collected 
☒ Data collected (paper and/or electronic) will be maintained in a secure location with appropriate 
protections such as password protection, encryption, physical security measures (locked 
files/areas) 
☐ Specimens collected will be maintained in a secure location with appropriate protections (e.g. 
locked storage spaces, laboratory areas) 
☒ Data and specimens will only be shared with individuals who are members of the IRB-approved 
research team or approved for sharing as described in this IRB protocol 
☒  Data and/or specimens requiring transportation from one location or electronic space to 
another will be transported only in a secure manner (e.g. encrypted files, password protection, 
using chain-of-custody procedures, etc.) 
☒   All electronic communication with participants will comply with Mass General Brigham secure 
communication policies 
☒ Identifiers will be coded or removed as soon as feasible and access to files linking identifiers 
with coded data or specimens will be limited to the minimal necessary members of the research 
team required to conduct the research 
☒ All staff are trained on and will follow the Mass General Brigham policies and procedures for 
maintaining appropriate confidentiality of research data and specimens 
☒ The PI will ensure that all staff implement and follow any Research Information Service Office 
(RISO) requirements for this research 
☐ Additional privacy and/or confidentiality protections 
 
 
 
Describe below: 
 
 
12. References 
 
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5. Zheng Z, Jemal A, Han X, et al. Medical financial hardship among cancer survivors in the United 
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