Characterizing and Addressing Financial Toxicity in Adolescents and Young Adults With Cancer
Phase: NA
Conditions: Cancer in Adolescence
Sponsor: Columbia University

Characterizing and Addressing Financial 
Toxicity in Adolescents and Young Adults with 
Cancer 
***This study has completed the first phase of beta testing the intervention to determine logistical 
processes, and will now move to the full pilot study with an accrual goal of n=60 AYAs. During 
the beta testing, 18 individuals were screened, representing 11 AYAs, and of these 11 AYAs, 6 
screened positive and moved on to receive the intervention. The intent of the beta phase was to 
establish processes and procedures to identify, enroll, and navigate participants to the 
intervention, including to our community partner, the Patient Advocate Foundation (see below). 
We have established such procedures as reflected in the study procedures here, and will now 
move forward with the full pilot study.*** 
Aim 1: Among AYAs receiving cancer treatment or diagnosed with cancer in the last 6 
months, to screen for financial and health-related social health needs (HRSN). We will 
administer a baseline needs assessment to all eligible AYAs and caregivers who consent to 
participate in the study. The survey will assess financial distress, HRSN, and the participant’s 
desire to receive support to address unmet needs.   
Aim 2: Among AYAs with a positive social health screen, to determine the feasibility and 
utility of direct provision and navigation to community resources on reducing financial 
distress and HRSN.   
We will deliver the resource provision and navigation intervention to as many as N=30 AYAs 
and assess feasibility by evaluating program completion (6-months), participant-reported 
acceptability. We will gather evidence of efficacy by measuring change in average financial 
distress score between baseline and 6-month time points; and by measuring change in HRSN 
score.  
Study Overview: Through the knowledge gained during the Columbia Nursing Pilot Award, and 
the interview data from n=20 AYAs and caregivers about their financial experiences and 
healthrelated social needs during cancer treatment, we have developed the preliminary 
components of an intervention to reduce financial distress and health-related social health needs 
(HRSN) for AYAs and caregivers. We will conduct a baseline needs assessment among all eligible 
and interested AYAs with cancer, and caregivers; then, we will deliver the intervention to AYAs 
and caregivers who screen positive for financial or HRSN and assess the feasibility and efficacy 
of the intervention. Feasibility will be assessed through participation and completion rates, and 
participant feedback; the impact of the intervention will be explored by the change in financial 
distress and improvement in HRSN scores.  
Subjects and eligibility: We will enroll up to 60 AYA and caregiver pairs; non-paired AYAs will also 
be eligible to participate (see Human Subjects). AYAs who were diagnosed with cancer or began 
treatment for cancer within the past 6-months or those who are still on first treatment for cancer 
(non-relapse) will be eligible to participate; caregivers will be eligible to co-participate with an 
enrolled AYA. We will aim to recruit across age (15 - 25, 26 - 39), race/ethnicity, and language 
to 
Date: 11/21/24
NCT06072833

achieve at least representativeness of the AYA catchment in upper NYC. Given our preliminary 
data on younger AYAs, we will make every attempt to oversample from the 15 – 25 and related 
caregivers to ensure an understanding of potentially unique needs for these younger AYAs.  
Procedures: We will obtain consent from interested participants; all will complete the baseline 
financial and HRSN assessment (Table 1), and those who screen positive (defined below) will 
receive the intervention.  
Table 1: Proposed Measures and Brief Description 
Measure 
Brief description and completion time 
Analytic approach 
Aim(s) 
Sociodemographic 
assessment 
Participant-reported 
Includes race, ethnicity, sex, age, employment 
status, household income, insurance type, 
education completed, health literacy,1 
relationship status, and relation to AYA, if 
applicable (5-min) 
Each discrete covariate 
approached as 
categorical 
1  
Financial distress 
measures 
AYA: Original Cost measure, Financial burden 
survey (optional)(10-min) 
Scored and analyzed as 
continuous scale (range 
1  
Caregiver: InCharge/Personal Financial 
Wellness Scale (PFWS), Financial burden 
survey (optional) (10-min) 
depends on final number 
of items) 
Financial and health 
related social needs 
(HRSN) assessment 
Household material hardship (HMH),2 out-
ofpocket costs, coping behaviors (NCI-2021- 
03567) (5-min) 
Each covariate 
approached as 
categorical 
1  
Global Health 
(Physical, Mental & 
Social Health) 
PROMIS Global Health3 (18y and older): 10items 
PROMIS Pediatric Global Health4 (< 18 years): 9-
items scored on Likert scale (5-min) 
Scored and analyzed as 
categorical scale 
1  
Resilience 
Connor-Davidson Resilience Scale (CD-RISC- 
10): 10-items (5-min)5 
Scored and analyzed as 
continuous scale (range 
depends on final number 
of items) 
1 
Feasibility measures 
Acceptability of Intervention Measure (AIM), 
Intervention Appropriateness Measure (IAM), and 
Feasibility of Intervention Measure (FIM)5 scored 
on a 5-point Likert scale, 12-items (5-min) 
Scored and analyzed as 
categorical scale 
2 
Aim 1 and 2: AYAs and Caregivers: 
We will conduct a baseline needs assessment among n=60 AYAs/caregiver pairs, and then, 
among those who screen positive for financial and HRSN, we will administer the Financial 
Education/Financial Navigation (FE/FN) intervention to tracas many as 30 AYA and caregiver 
pairs; up to N=45 participants will be included to allow for non-paired AYAs. English and Spanish 
language preferers will be eligible.  
The process for the intervention will include the following: 
Baseline assessment (all participants): Each AYA or caregiver will complete a baseline financial 
and social health risk assessment. Surveys will be completed using a secure, REDCap link either 
via a virtual platform (e.g. zoom or WhatsApp, both encrypted) using a REDCap link, or in-
person 

either using an iPad or paper version, per the participant’s preference and comfort level. The 
study coordinator will be available to navigate the participant through the questions, if needed.  
Positive screen: AYAs will be considered “positive screens for financial/HRSN” if they meet any 
of the following criteria: (screening status will be determined within 1 week of study enrollment)  
•
AYA who scores < 22 on the COST measure, below the median score in validation studies
for financial distress8
•
Caregiver who scores “high” on the PFWS measure (score range 1-4)9
•
AYA or caregiver who respond “yes” to any of the 4 material hardship domains (food,
housing, transportation, energy)
•
AYA or caregiver who respond “yes” to the question asking if they have unmet financial or
social needs that they would like help addressing.
Participants with a “positive screen” as above will proceed with the intervention. Those who do 
not screen positive will be given a resource sheet that has been developed with the social work 
team at CUIMC and will be asked to complete a follow-up assessment 6-months after initial study 
entry (+/- 1 month).  
We have established partnerships with local CBOs through the HICCC Community Outreach & 
Engagement (COE) Core, and the Patient Advocate Foundation (PAF). PAF is a nonprofit 
organization geared towards solving the issues faced by patients facing chronic illness. They have 
a case management program that is available to the public, but patients often are unaware or 
unable to connect with PAF for various reasons, our research shows. In this study, we will identify 
patients experiencing financial or health-related social needs and then connect them directly with 
PAF and their case management team. We will share minimal information (patient name, age, 
diagnosis, and needs for which they screened positive) and patient preferred contact phone 
number with PAF to ensure their team is aware that our enrolled participant is in need of case 
management services. This Data Use Agreement (attached) will allow us to share minimal 
information between teams to ensure resource referrals are made for the patient and to 
understand and study how we can better improve this care delivery intervention. From prior 
qualitative research, we have developed this intervention and training and monitoring procedures 
to ensure intervention fidelity. These are all organizational capabilities both locally within our 
community and through national collaborations. 
In our beta testing phase, we learned that for some AYAs and caregivers, connecting by telephone 
with PAF is perceived to be difficult; some participants never connected with the organization to 
receive needs navigation support. We have explored the use of a digital network of community 
resources that is publicly available through findhelp.org, and in this next phase of development, 
we will incorporate this platform to understand participants’ perception, uptake, and engagement 
with findhelp.org.  
Therefore, when participants who screen positive are contacted to assess their interest in 
continuing with the intervention, we will offer connection to PAF and findhelp.org. As in the beta 
testing, we will conduct monthly check-ins with participants and will ask if they accessed 
findhelp.org, if they used the search engine to identify community resources, if they connected 
with the community partner, and what the outcome of the connection was. These data will be 
important to inform future scaling of the intervention and understand the capacity of findhelp.org 
in addressing unmet financial and social needs. 

Intervention Group: 
1. AYAs with self-reported or caregiver-reported HRSN, specifically food or transportation
insecurity, will be given a direct provision (e.g. voucher) to support immediate costs by the
coordinator.
2. AYAs with self-reported or caregiver-reported HRSN will be navigated by the coordinator
to our partner community-based organization (Patient Advocate Foundation, publicly
available via a phone or web-based access) who will conduct their standard intake
assessment and subsequent navigation with the individual patient and, if participating, the
caregiver.
a. The study team will communicate at regular intervals (weekly, more often as
needed) with PAF team to notify them of newly-participating subject. Study team
will share subject’s name, age, language preference, and reported needs from the
needs assessment to facilitate PAF in determining the case manager who will be
in contact with the subject throughout the study period.
b. PAF will share information with the study team including but not limited to: number
of contacts with subject, uptake with recommended resources, need for additional
support services, outstanding needs, and resolved needs.
c.
Study team will follow-up with the AYA, and if applicable, caregiver, at least
monthly for 6-months for a brief structured survey interview to assess participant
satisfaction, needs addressed, and need for additional navigation or support.
3.
Given the limitations identified in our beta testing in connecting participants with
PAF, as well as PAF is not available to non-U.S. citizens, the study team will offer the
AYA/caregiver the resource sheet, as described above, and will further provide direct
navigation support to the findhelp.org website, which is a repository of locally-available
resources that can be sorted by citizenship.
As with those who do not have a positive screen, another needs assessment survey, including 
12-items to assess the acceptability, feasibility, and implementability of the intervention, will be
administered to all participants at 6-months. 
Identification and Recruitment of Eligible AYA Participants and Caregivers 
AYA patients and caregivers will be recruited through the AYA Program at CUIMC. This 
collaborative clinical effort includes the Division of Pediatric Hematology/Oncology/Stem Cell 
Transplantation, and the Division of Hematology/Oncology. We also have existing collaborations 
with Gynecologic Oncology and will recruit through their division. We will leverage these 
collaborations to identify and recruit eligible participants. To avoid selection bias, a list of 
potentially-eligible patients will be created from the electronic health record (EHR) every month. 
All potentially-eligible participants will be screened for participation; however, we will review 
accrual data monthly and if certain groups are underrepresented (age, race/ethnicity, tumor type), 
we will make every attempt to improve our recruitment strategies to these groups of patients. A 
TRAC request will also be submitted for the results of the SDOH screener implemented in the 
Pediatric Oncology and Breast Oncology clinic. The SDOH screener is a part of SOC and has 
been in-progress of undergoing integration into oncology clinics at CUIMC. These results will be 
used to justify our target groups. Patients on the original list created from the EHR that screened 
positive for food, transit, or housing insecurity will be recruited for the study.  

As a Minority/Underserved NCI-Community Oncology Research Program (NCORP) institution, 
we have established procedures in place for partnering with the clinical teams, utilizing 
patientfacing recruitment materials, and ultimately recruiting more than 40% of clinical study 
participants from racial/ethnic minority backgrounds. We will actively promote the study at CUIMC 
and will hold informational sessions with primary clinical teams to introduce the study. After initial 
discussions with the primary clinical teams through flyers, emails, or telephone, we will approach 
the AYAs and caregivers to present and discuss the research study.  
All eligible patients be recruited one of two ways: 
1.
Patients will be approached by a treating clinician to gauge interest in the study. The
patient will provide permission to the clinician to have us approach them about participation in the
study prior to contacting the patient.
2.
The PI will contact the treating physicians to introduce the study and inquire about allowing
access to their patients. Before the research team contacts the patient, the research team will
review a TRAC report (with an approved HIPAA form D - preparatory to research) and select
eligible individuals. The treating physicians will be asked to view and approve a list of potential
patients gathered from the TRAC request.. Eligible patients identified through this process will
first be sent the introductory letter via postal mail or email. The letter, signed by the relevant
medical director of the clinic that the treating physician of the patient (potential subject) is from,
will explain that the purpose of the study. The letter will explain what is being asked of them,
highlight the voluntary nature of the participation, and that non-participation will not impact their
relationship with their provider. The patient will be asked to opt-out if they are not interested in
participating. If, after 1 week, there is no response from the patient, we will make contact by
telephone to assess interest in participation - up to 3 calls. Patients interested in participating will
be consented over the phone or in person.
Informed Consent and Enrollment 
We will replicate procedures for minimal risk research using verbal consent procedures as are 
currently utilized for a similar study currently in place (3P30CA013696-45S2; IRB AAAT2937) to 
recruit, consent and retain AYA participants and caregivers.  
Eligible participants (who have not opted out) will be approached by a member of the research 
team either in person (clinic or hospital), or by telephone/video; participants will have the option 
to decline further information at that time.    
The research team will then begin with a concise and focused presentation of the key information 
about the research study including risks and benefits, study goals, and methods. The informed 
consent process will present the research study information in sufficient detail. The participant will 
also have time to ask questions and discuss the information provided with their family. If, after 
being introduced to the research and having had the opportunity to ask questions, participants 
are willing to participate, the study team will obtain and document the consent of the AYA and 
caregiver, and assent for AYAs < 18 years, and provide them with the information sheet either in 
paper form or electronically, depending on participant preference. Participants will be informed 
that they have the right to stop participating in the study at any time. AYA participants <18 years 

will be required to have parental participation; all other AYA participants will be encouraged, but 
not required, to identify a caregiver.   
Consent may take place either through in-person or over the phone or a videoconference. When 
electronically sending the verbal information sheet, all communication will be transmitted from an 
approved University Email System. Participants have reported this to reduce the burden and 
increase their satisfaction with our ongoing research studies that utilize this approach.   
To encourage study recruitment and retention as applicable, AYA and caregiver participants will 
each be offered gift card(s) to thank them for their time. These will be available as either physical 
gift cards or e-gift cards, depending on participant preference.   
Compensation will be as follows: $25 for Aim 1, a baseline needs assessment (25 minutes). $100 
for Aim 2, a one-time voucher to address food or transportation needs. $25 per time point 
completed (max $150) for Aim 2, monthly assessments x5 (15-45 min); 6-month follow-up (15-20 
min).  
To reduce participant burden and given COVID-19 restrictions, study operations will be conducted 
virtually wherever possible. We will utilize existing procedures for AAAT8368, Dr. Beauchemin’s 
CUSON Intramural Pilot Award study, offering remote consent form signing and survey 
participation using REDCap® database. This procedure includes sending a secure link to a 
participants’ email or mobile phone number, and the participant is able to view and sign the 
consent remotely, or able to complete surveys remotely, as study procedures indicate. This has 
been reported by participants to reduce the burden and increase their satisfaction with our 
ongoing research studies that utilize this approach.   
Table 2: Study recruitment goal and compensation for each aim 
Related Study Aim and Brief 
Description  
Expected commitment 
Compensation 
Aim 1: Screening for financial 
and health-related social 
needs. (N = 60 AYA; N = 60 
caregivers)  
Baseline needs assessment (25 
min)  
$25 
Aim 2: Financial and HRSN  
Navigation Pilot (N = 30 AYA; 
N = 30 caregivers)  
One-time voucher to address food 
or transportation needs  
$100 
Aim 2: Financial and HRSN  
Navigation Pilot (N = 30 AYA; 
N = 30 caregivers)  
Monthly assessments x5 (15 – 
45min); 6-month follow-up (15 – 
20min)  
$25 per time point 
completed (max $150) 
C.2. Potential Risks and Adequacy of Protection Against Risks

Aim 1 
Physical risks: There are no physical risks to subjects in the proposed study. 
Psychological risks: There is a possibility of anxiety or emotional distress for the AYAs or 
caregivers because of Aim 1 participating in surveys and, for Aim 2 financial/HRSN intervention, 
about cancer care, finances, and financial toxicity. Family finances are known to be a source of 
stress. The emotional risk of anxiety because of participating in surveys about this topic is 
expected to be minimal based on data from our prior research. There may be emotional risk of 
anxiety or distress because of discussing and learning about financial aspects of cancer care, 
including insurance, medication co-payment assistance, household material hardship, or other 
financial considerations and resources. However, prior work on this topic has revealed that 
patients and family members are eager to discuss this subject and do not report significant stress 
or anxiety because of participation; furthermore, patients and caregivers participating in prior 
studies on financial toxicity have identified an opportunity to speak about financial stresses as 
being beneficial to them. Participants may decide at any time and for any reason not to participate 
in the proposed study. To protect against this risk, those who express discomfort or stress during 
the survey or intervention will be referred to a psychosocial clinician for evaluation.   
Privacy risks (AYAs, caregivers): There is a risk of privacy violation or loss of confidentiality; 
however, this is anticipated to be minimal given that survey data will be collected using an 
institutional approved program (REDCap®), and that survey data will not be linked to patient data 
except in a locked datafile with codes to link patient information. This will only be used to collect 
clinical data for AYA participants (cancer type, date of diagnosis, treatment regimen). To protect 
PHI, participants will be approached and consented to enrollment in private settings, and surveys 
will be administered either through a unique link sent to the participant’s email or mobile phone, 
per participant preference; if neither is preferred, a study team member will be available to conduct 
the survey using a tablet in a private space in clinic. All study form hard copies will be kept in 
participants’ study files in locked drawers to which only the designated study team member has a 
key. All electronic data will be kept on secured servers as managed by the Columbia University 
School of Nursing.   
Survey Data will be collected using a RedCap® database. Confidentiality of each patient will be 
maintained, although chart review of the patients’ histories will be required. All study participants 
will be assigned a unique study ID. Their survey responses will be linked to this study ID. All study 
information will be stored in locked file cabinets and in password-protected computer files. Only 
authorized study personnel will have access to these files. This is a minimal risk study focused 
on collection of patient-reported survey data for research. There is a small risk of release of 
medical data that is not intended.  
C.3. Potential Benefits of the Proposed Research to Human Subjects and Others
We hope that participation in Aim 2 may provide some benefit to subjects enrolled by reducing 
financial and HRSN; this is however a feasibility study and therefore this is not the primary 
outcome measure of Aim 2. In other research of this nature, we have found that participants 
appreciate the opportunity to discuss their worries about finances as pertains to cancer care. 
Thus, subjects may find the experience of participating in the interviews to be beneficial in 
this 
V

fashion. This study represents minimal risk to participants. Thus, the anticipated minimal risks are 
justified in balance with the importance of the knowledge to be gained and the potential future 
benefits to patients.  
C.4. Importance of Knowledge to be Gained and Justification for Human Subjects
Survivors of cancer are at risk of financial toxicity, and AYAs are disproportionately affected by 
this negative adverse effect of cancer treatment. Though measures exist for adults with cancer, 
and interventions are currently being tested and demonstrated early reduction of financial toxicity 
among adult cancer patients, to design measures and interventions to reduce financial toxicity 
among this vulnerable population, we need to understand their unique experience with financial 
costs of care and subsequent financial toxicity. AYAs with cancer, their parents, caregivers, and 
healthcare team members for AYAs with cancer represent the sole source of this information, and 
thus this research cannot be  
C.5 Inclusion of Women and Minorities
This study does not focus on any particular race, ethnicity, or gender. No potential research 
subjects will be excluded from enrollment on the basis of race, ethnic origin, or gender. This 
study focuses on AYAs (age 15 – 39 years) with cancer and will enroll racial and ethnic 
minorities in a manner that is proportional to the proportion of racial and ethnic minorities 
diagnosed with AYA cancer at CUIMC; currently over 40% of AYAs with cancer treated at 
CUIMC identify from racial or ethnic minority groups. As an NCI Minority-Underserved NCI 
Community Oncology Research Program, the HICCC has a robust infrastructure in place to 
recruit and retain underserved minority patients onto clinical trials. This includes availability of 
translation services (in case bilingual study members are unavailable), Community Outreach 
and Engagement Core collaborations within the HICCC and across the local community near 
the institution, including Northern Manhattan, Washington Heights/Inwood (of whom nearly 80% 
of the population identify as Hispanic/Latinx), and Harlem.   
The study sample for each Aim will be from the same source population, the AYA patient 
population at HICCC, which broadly reflects the HICCC catchment area (81% Hispanic/Latinx or 
non-White; 46% foreign-born; 20% below the poverty line).   
Aim 1 will include surveys that will be available in 2 language (English, Spanish) which represent 
the most frequent languages spoken at CUIMC.   
Based on HICCC tumor registry data, we expect eligible AYA participants will be approximately 
55% female and 45% male. Caregiver participation is expected to be a majority female as 
mothers are more likely to contribute research study information compared with fathers in our 
and others experience. However, because we include caregivers or other partners, we do not 
expect the traditional 75% female/25% male ratio; we anticipate 60% female and 40% male. 
Racial and ethnic minority participants will be eligible to participate. On the basis of HICCC 
tumor registry, we expect that approximately 50% of enrolled AYAs will be non-Hispanic White, 
and the other 50% non-White (20% Black/African American, 2% Asian, and 28% Other or more 
than one Race). We expect that approximately 40% of enrolled AYAs will be Hispanic/Latinx, 
55% Non-Hispanic, and 5% Unknown. Because of the current underrepresentation of non-White 
patients in the financial toxicity literature, and because of the current catchment area diversity at 

HICCC, we expect and will aim to achieve an overrepresentation of Black/African American and 
Hispanic/Latinx participants compared with national averages.  
For the Key Stakeholder discussions (Aim 3, will occur at later date), target populations for 
enrollment include members of the healthcare team (physicians, nurse practitioners, nurses, 
psychologists, child life specialists, social workers), who provide care for AYAs with cancer, and 
AYA patient advocates who have intimate knowledge about AYA cancer. No potential research 
subjects will be excluded from enrollment on the basis of race, ethnic origin or gender. Given 
the gender breakdown of the pediatric and medical oncology workforce at HICCC, we expect a 
slight overrepresentation of women in the eligible healthcare team sample. We will intentionally 
attempt to sample male clinicians when possible. We will purposefully sample to target a 
racial/ethnic minority breakdown reflective of the HICCC provider population  
C.7 Data and Safety Monitoring
The frequency and complexity of risks associated with these studies are overall expected to be 
minimal. As such, the PI, Dr. Melissa Beauchemin, and the CUIMC IRB will oversee Data and 
Safety Monitoring for the proposed studies. We will proactively review and evaluate the 
appropriateness of the data that is being generated from the proposed research aims, specifically 
Aim 2, intervention feasibility testing. This information will be utilized to inform process measures 
for future studies. We will check the quality of our data monthly to assess for 1) intervention fidelity, 
2) appropriate measurement of outcomes, 3) assess for adverse events, 4) analyze reasons for
attrition, 5) examine feasibility and acceptability, and 6) ensure that we are generating data that
is reproducible in future studies.
Study activity 
Month 
1 
Month 
2 
Month 
3 
Month 
4 
Month 
5 
Month 
6 
Approach, consent, and 
conduct baseline 
assessments for all eligible 
participants (i.e. AYAs 
diagnosed with cancer in the 
last 6 months or still on 
treatment)  
X 

Among participants with a 
positive social health screen, 
we will deliver the resource 
provision and navigation 
intervention with Patient 
Advocate Foundation or 
findhelp.org. 
Among participants who do 
not screen positive, we will 
provide a resource sheet  
X 
Monthly check-in. Conduct a 
brief survey with participants 
who have received navigation 
intervention to assess 
participant satisfaction, needs 
addressed, and need for 
additional navigation or  
support  
X 
X 
X 
X 
6-month survey.
Contact all participants to
complete needs assessment
survey; for intervention group,
also assess acceptability,
feasibility, and
implementability of the
intervention
X 
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