Characterizing and Addressing Financial Toxicity in AYAs With Cancer

NCT06072833 | Completed Results

• 2 other identifiers: AAAU24055KL2TR001874
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cancer in Adolescence

Keywords

Cancer; Adolescents; Young Adults; Financial Needs; Social Needs; Minority health; Caregivers

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 6 months

Secondary Outcomes (1)

• Comprehensive Score of Financial Toxicity (COST Measure) Score

  Baseline, 6 months

Study Arms (1)

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.

Behavioral: Patient Financial Education / Navigation

Interventions

Patient Financial Education / Navigation BEHAVIORAL

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.

Patients Eligible (screened positive)

Eligibility Criteria

• Age: 15 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Unable to complete financial survey questions or contraindicated (as outlined in Protection of Human Subjects)

Sponsors & Collaborators

• Patient Advocate Foundation: collaborator
• Columbia University: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (9)

• 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.

  PMID: 23442307 BACKGROUND

• Altice 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.

  PMID: 27754926 BACKGROUND

• Yabroff 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.

  PMID: 26644532 BACKGROUND

• Parsons 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.

  PMID: 22614977 BACKGROUND

• Nipp 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.

  PMID: 28817372 BACKGROUND

• de 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.

  PMID: 27716900 BACKGROUND

• Danhauer 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.

  PMID: 34699110 BACKGROUND

• Beauchemin 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.

  BACKGROUND

• 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.

  PMID: 40726516 DERIVED

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Melissa Beauchemin
• Organization: Columbia University School Of Nursing

mmp2123@cumc.columbia.edu

212-342-4111

Study Officials

• Melissa Beauchemin

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Nursing

Model Details: Participants who screen positive all move forward to receive the intervention.

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 10, 2023
• Study Start: November 15, 2023
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: March 16, 2026
• Results First Posted: March 16, 2026

Record last verified: 2026-02

Locations

US (1)