Cancer in AdolescenceNCT06072833
Characterizing and Addressing Financial Toxicity in AYAs With Cancer
A study testing Patient Financial Education / Navigation in people with Cancer in Adolescence, run by Columbia University at 1 site in United States.
Trial summary
The overall aims of this study are to address two important gaps in care for AYA cancer patients: 1) a financial toxicity measurement tool to assess AYA-specific needs, and 2) an intervention for mitigating financial toxicity in this population. Read more about this study
- Who is it for?
- Ages 15 to 39 years
- Conditions the study is for
- Cancer in Adolescence
- What is being tested?
- Patient Financial Education / Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2023to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- AYA patient participants:
- Age 15 - 39 years old
- English or Spanish-speaking
- Diagnosed with cancer that required treatment within past 18 months
- Not currently on hospice care
- Caregiver/financial partner participants:
- Parent or financially-responsible adult of non-adult AYA (<18 years) OR
- Identified by the AYA as caregiver, parent, or partner who is financially-responsible or a financial partner for AYA
Who cannot join
- Unable to complete financial survey questions or contraindicated (as outlined in Protection of Human Subjects)
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Characterizing and Addressing Financial Toxicity in Adolescents and Young Adults With Cancer
The overall aims of this study are to address two important gaps in care for AYA cancer patients: 1) a financial toxicity measurement tool to assess AYA-specific needs, and 2) an intervention for mitigating financial toxicity in this population. Aim 1 involves adapting the COSTA measure and assessing the psychometric properties of the measure for a racial/ethnically diverse group of AYAs. Aim 2 and 3 involve the development and pilot testing of our novel financial education/ navigation (FE/FN) intervention.
Read the detailed description
Financial toxicity is the harmful personal financial burden faced by patients due to healthcare needs. A prevalent adverse outcome of cancer therapy, financial toxicity is associated with poorer health outcomes and increased mortality in adults with cancer. Among cancer survivors, financial burden disproportionately impacts adolescents and young adults (AYA: 15 - 39 years). Lack of financial security, insurance gaps or under-insurance, and interruptions in education or careers caused by cancer therapy make AYA cancer survivors particularly vulnerable to financial burden. Financial toxicity of cancer care is an actionable factor impacting outcomes among vulnerable AYA populations. In order to improve outcomes and reduce the burden of care among these populations, targeted, appropriate measures and then, age-specific interventions are needed. The study includes the following aims: Aim 1 involves the adaptation of the COST measure and assessment of the psychometric properties of the measure for a racial/ethnically diverse group of AYAs. The study team will administer COST and additional AYA-specific financial toxicity candidate items to N=150 AYAs. The study will assess validity of original COST through confirmatory factor analysis; assess reliability through test/retest; conduct exploratory factor analysis on modified COST incorporating added items; and describe AYA-reported acceptability of AYA financial toxicity assessment.
In Aim 2, an adapted FN/FE intervention will be adapted for a racial/ethnically diverse group of AYAs. 6 focus groups (6 - 8 per group) will be conducted with a diverse AYAs and caregivers, and brief stakeholder discussions to understand unique AYA FE/FN needs and inform intervention refinement.
Aim 3 will include a pilot test of our novel FE/FN intervention to AYAs. A FE/FN intervention will be delivered to at least N=30 AYAs, and assess feasibility by evaluating program completion (6-months), participant-reported acceptability. Evidence of efficacy will be recorded by measuring improvement in average financial toxicity score between baseline and 6-month time points.
- Conditions
- Cancer in Adolescence
- Being tested
- Patient Financial Education / Navigation
- Keywords
- Cancer, Adolescents, Young Adults, Financial Needs, Social Needs, Minority health, Caregivers
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Financial Education / NavigationBehavioural
The investigator anticipates that this will include a baseline financial assessment and educational content, likely using a virtual platform. Participants will be connected with a PAF case manager. There will be monthly follow-ups to the participant for 6-months to address any financial concerns through additional counseling/navigation.
| Study group | Role | What they receive |
|---|---|---|
| Patients Eligible (screened positive) | Experimental | Individuals who screen positive will all move forward to receive the intervention. This intervention includes partnering with community-based organizations to deliver financial education, connection to resources, and counseling tailored to individual patients and spouses for 6-months. Receives: Behavioral: Patient Financial Education / Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Completed the Intervention
This is to assess the feasibility of intervention completion. Intervention completion is defined as participants who have demonstrated contact with community partners at any time before the end of 6 months.
Measured: Up to 6 months
Number of Eligible Participants Who Received the Intervention
This is to measure interest and the need for help by community partners that can provide patient financial education and navigation.
Measured: Up to 6 months
Secondary outcomes (1)
Comprehensive Score of Financial Toxicity (COST Measure) Score
The COST is a patient-reported outcome measure that describes the financial distress experienced by cancer patients. It is a 11-item questionnaire with a score range of 0-44. Lower COST values indicate higher toxicity. Higher scores indicate lower financial toxicity .
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start15 Nov 2023
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cancer in AdolescenceStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants who screen positive all move forward to receive the intervention.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient Advocate Foundation, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Melissa Beauchemin, Columbia University
- Investigators
- Melissa Beauchemin, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072833
- Sponsor's protocol ID
- AAAU2405
- Other IDs
- 5KL2TR001874
- Status last verified
- Feb 2026
- First submitted
- 3 Oct 2023
- Last updated
- 16 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zafar SY, Peppercorn JM, Schrag D, Taylor DH, Goetzinger AM, Zhong X, Abernethy AP. The financial toxicity of cancer treatment: a pilot study assessing out-of-pocket expenses and the insured cancer patient's experience. Oncologist. 2013;18(4):381-90. doi: 10.1634/theoncologist.2012-0279. Epub 2013 Feb 26.
PubMed 23442307Altice CK, Banegas MP, Tucker-Seeley RD, Yabroff KR. Financial Hardships Experienced by Cancer Survivors: A Systematic Review. J Natl Cancer Inst. 2016 Oct 20;109(2):djw205. doi: 10.1093/jnci/djw205. Print 2017 Feb.
PubMed 27754926Yabroff KR, Dowling EC, Guy GP Jr, Banegas MP, Davidoff A, Han X, Virgo KS, McNeel TS, Chawla N, Blanch-Hartigan D, Kent EE, Li C, Rodriguez JL, de Moor JS, Zheng Z, Jemal A, Ekwueme DU. Financial Hardship Associated With Cancer in the United States: Findings From a Population-Based Sample of Adult Cancer Survivors. J Clin Oncol. 2016 Jan 20;34(3):259-67. doi: 10.1200/JCO.2015.62.0468. Epub 2015 Dec 7.
PubMed 26644532Parsons HM, Harlan LC, Lynch CF, Hamilton AS, Wu XC, Kato I, Schwartz SM, Smith AW, Keel G, Keegan TH. Impact of cancer on work and education among adolescent and young adult cancer survivors. J Clin Oncol. 2012 Jul 1;30(19):2393-400. doi: 10.1200/JCO.2011.39.6333. Epub 2012 May 21.
PubMed 22614977Nipp RD, Kirchhoff AC, Fair D, Rabin J, Hyland KA, Kuhlthau K, Perez GK, Robison LL, Armstrong GT, Nathan PC, Oeffinger KC, Leisenring WM, Park ER. Financial Burden in Survivors of Childhood Cancer: A Report From the Childhood Cancer Survivor Study. J Clin Oncol. 2017 Oct 20;35(30):3474-3481. doi: 10.1200/JCO.2016.71.7066. Epub 2017 Aug 17.
PubMed 28817372de Souza JA, Yap BJ, Wroblewski K, Blinder V, Araujo FS, Hlubocky FJ, Nicholas LH, O'Connor JM, Brockstein B, Ratain MJ, Daugherty CK, Cella D. Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST). Cancer. 2017 Feb 1;123(3):476-484. doi: 10.1002/cncr.30369. Epub 2016 Oct 7.
PubMed 27716900Danhauer SC, Canzona M, Tucker-Seeley RD, Reeve BB, Nightingale CL, Howard DS, Puccinelli-Ortega N, Little-Greene D, Salsman JM. Stakeholder-informed conceptual framework for financial burden among adolescents and young adults with cancer. Psychooncology. 2022 Apr;31(4):597-605. doi: 10.1002/pon.5843. Epub 2021 Nov 5.
PubMed 34699110Beauchemin MP, Elkin EB, Wright JD, Kukafka R, Hershman DL, Kahn J. Incorporating systematic financial screening into the electronic health record. Journal of Clinical Oncology. 2021;39(28_suppl):184-184.
Khurana RK, Valera K, Raghunathan R, Gallagher KD, Angove RS, Bradshaw E, Patton J, Alvarado S, Crespo S, Judon K, DiCola K, Steinberg DM, Wang S, Hershman DL, Beauchemin MP. Pilot feasibility of a financial and health-related social needs navigation intervention (AYA-NAV) for adolescents and young adults with Cancer: Study protocol for a prospective, single-arm study. Contemp Clin Trials Commun. 2025 Jul 16;47:101523. doi: 10.1016/j.conctc.2025.101523. eCollection 2025 Oct.
PubMed 40726516
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing and Addressing Financial Toxicity in Adolescents and Young Adults With Cancer
- ClinicalTrials.gov ID
- NCT06072833
- Acronym / sponsor ID
- AAAU2405
- Conditions
- Cancer in Adolescence
- Keywords
- Cancer, Adolescents, Young Adults, Financial Needs, Social Needs, Minority health, Caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Patient Advocate Foundation, National Center for Advancing Translational Sciences (NCATS)
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Posted 16 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall aims of this study are to address two important gaps in care for AYA cancer patients: 1) a financial toxicity measurement tool to assess AYA-specific needs, and 2) an intervention for mitigating financial toxicity in this population. Aim 1 involves adapting the COSTA measure and assessing the psychometric properties of the measure for a racial/ethnically diverse group of AYAs. Aim 2 and 3 involve the development and pilot testing of our novel financial education/ navigation (FE/FN) intervention.
Detailed description
Financial toxicity is the harmful personal financial burden faced by patients due to healthcare needs. A prevalent adverse outcome of cancer therapy, financial toxicity is associated with poorer health outcomes and increased mortality in adults with cancer. Among cancer survivors, financial burden disproportionately impacts adolescents and young adults (AYA: 15 - 39 years). Lack of financial security, insurance gaps or under-insurance, and interruptions in education or careers caused by cancer therapy make AYA cancer survivors particularly vulnerable to financial burden. Financial toxicity of cancer care is an actionable factor impacting outcomes among vulnerable AYA populations. In order to improve outcomes and reduce the burden of care among these populations, targeted, appropriate measures and then, age-specific interventions are needed. The study includes the following aims: Aim 1 involves the adaptation of the COST measure and assessment of the psychometric properties of the measure for a racial/ethnically diverse group of AYAs. The study team will administer COST and additional AYA-specific financial toxicity candidate items to N=150 AYAs. The study will assess validity of original COST through confirmatory factor analysis; assess reliability through test/retest; conduct exploratory factor analysis on modified COST incorporating added items; and describe AYA-reported acceptability of AYA financial toxicity assessment.
In Aim 2, an adapted FN/FE intervention will be adapted for a racial/ethnically diverse group of AYAs. 6 focus groups (6 - 8 per group) will be conducted with a diverse AYAs and caregivers, and brief stakeholder discussions to understand unique AYA FE/FN needs and inform intervention refinement.
Aim 3 will include a pilot test of our novel FE/FN intervention to AYAs. A FE/FN intervention will be delivered to at least N=30 AYAs, and assess feasibility by evaluating program completion (6-months), participant-reported acceptability. Evidence of efficacy will be recorded by measuring improvement in average financial toxicity score between baseline and 6-month time points.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants who screen positive all move forward to receive the intervention.
| Arm | Type | Receives |
|---|---|---|
| Patients Eligible (screened positive) | Experimental | Behavioral: Patient Financial Education / NavigationIndividuals who screen positive will all move forward to receive the intervention. This intervention includes partnering with community-based organizations to deliver financial education, connection to resources, and counseling tailored to individual patients and spouses for 6-months. |
Who may qualify
- Ages
- 15 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Age 15 - 39 years old
- English or Spanish-speaking
- Diagnosed with cancer that required treatment within past 18 months
- Not currently on hospice care
- Parent or financially-responsible adult of non-adult AYA (<18 years) OR
Key exclusion criteria (1 listed)
- Unable to complete financial survey questions or contraindicated (as outlined in Protection of Human Subjects)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Financial Education / NavigationThe investigator anticipates that this will include a baseline financial assessment and educational content, likely using a virtual platform. Participants will be connected with a PAF case manager. There will be monthly follow-ups to the participant for 6-months to address any financial concerns through additional counseling/navigation. | Behavioural | Patients Eligible (screened positive) |
Primary outcome
Number of Participants Who Completed the Intervention
Time frame: Up to 6 months
This is to assess the feasibility of intervention completion. Intervention completion is defined as participants who have demonstrated contact with community partners at any time before the end of 6 months.
Number of Eligible Participants Who Received the Intervention
Time frame: Up to 6 months
This is to measure interest and the need for help by community partners that can provide patient financial education and navigation.
1 secondary outcome
Comprehensive Score of Financial Toxicity (COST Measure) Score
Time frame: Baseline, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23442307Zafar SY, Peppercorn JM, Schrag D, Taylor DH, Goetzinger AM, Zhong X, Abernethy AP. The financial toxicity of cancer treatment: a pilot study assessing out-of-pocket expenses and the insured cancer patient's experience. Oncologist. 2013;18(4):381-90. doi: 10.1634/theoncologist.2012-0279. Epub 2013 Feb 26.
- Background: PubMed 27754926Altice CK, Banegas MP, Tucker-Seeley RD, Yabroff KR. Financial Hardships Experienced by Cancer Survivors: A Systematic Review. J Natl Cancer Inst. 2016 Oct 20;109(2):djw205. doi: 10.1093/jnci/djw205. Print 2017 Feb.
- Background: PubMed 26644532Yabroff KR, Dowling EC, Guy GP Jr, Banegas MP, Davidoff A, Han X, Virgo KS, McNeel TS, Chawla N, Blanch-Hartigan D, Kent EE, Li C, Rodriguez JL, de Moor JS, Zheng Z, Jemal A, Ekwueme DU. Financial Hardship Associated With Cancer in the United States: Findings From a Population-Based Sample of Adult Cancer Survivors. J Clin Oncol. 2016 Jan 20;34(3):259-67. doi: 10.1200/JCO.2015.62.0468. Epub 2015 Dec 7.
- Background: PubMed 22614977Parsons HM, Harlan LC, Lynch CF, Hamilton AS, Wu XC, Kato I, Schwartz SM, Smith AW, Keel G, Keegan TH. Impact of cancer on work and education among adolescent and young adult cancer survivors. J Clin Oncol. 2012 Jul 1;30(19):2393-400. doi: 10.1200/JCO.2011.39.6333. Epub 2012 May 21.
- Background: PubMed 28817372Nipp RD, Kirchhoff AC, Fair D, Rabin J, Hyland KA, Kuhlthau K, Perez GK, Robison LL, Armstrong GT, Nathan PC, Oeffinger KC, Leisenring WM, Park ER. Financial Burden in Survivors of Childhood Cancer: A Report From the Childhood Cancer Survivor Study. J Clin Oncol. 2017 Oct 20;35(30):3474-3481. doi: 10.1200/JCO.2016.71.7066. Epub 2017 Aug 17.
- Background: PubMed 27716900de Souza JA, Yap BJ, Wroblewski K, Blinder V, Araujo FS, Hlubocky FJ, Nicholas LH, O'Connor JM, Brockstein B, Ratain MJ, Daugherty CK, Cella D. Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST). Cancer. 2017 Feb 1;123(3):476-484. doi: 10.1002/cncr.30369. Epub 2016 Oct 7.
- Background: PubMed 34699110Danhauer SC, Canzona M, Tucker-Seeley RD, Reeve BB, Nightingale CL, Howard DS, Puccinelli-Ortega N, Little-Greene D, Salsman JM. Stakeholder-informed conceptual framework for financial burden among adolescents and young adults with cancer. Psychooncology. 2022 Apr;31(4):597-605. doi: 10.1002/pon.5843. Epub 2021 Nov 5.
- BackgroundBeauchemin MP, Elkin EB, Wright JD, Kukafka R, Hershman DL, Kahn J. Incorporating systematic financial screening into the electronic health record. Journal of Clinical Oncology. 2021;39(28_suppl):184-184.
- Derived from this study: PubMed 40726516Khurana RK, Valera K, Raghunathan R, Gallagher KD, Angove RS, Bradshaw E, Patton J, Alvarado S, Crespo S, Judon K, DiCola K, Steinberg DM, Wang S, Hershman DL, Beauchemin MP. Pilot feasibility of a financial and health-related social needs navigation intervention (AYA-NAV) for adolescents and young adults with Cancer: Study protocol for a prospective, single-arm study. Contemp Clin Trials Commun. 2025 Jul 16;47:101523. doi: 10.1016/j.conctc.2025.101523. eCollection 2025 Oct.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Beauchemin principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Financial Education / Navigation in people with Cancer in Adolescence, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Completed the Intervention (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06072833, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.