Needs Navigation for Caregivers of AYAs

NCT06296641 | Enrolling By Invitation

• 1 other identifier: AAAU9477
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of the study is to address unmet health-related social needs and reduce outcome disparities among AYA (adolescent and young adult) cancer survivors. Aim 1 aimed to refine a needs navigation model in partnership with expert consultants. Aim 2 and 3 will involve the deployment and pilot testing of the adapted needs navigation intervention among caregivers of younger AYAs with cancer.

Conditions

Cancer in Adolescence

Keywords

Cancer; Adolescents; Young adults; Financial needs; Social needs; Minority health; Caregivers

Outcome Measures

Primary Outcomes (2)

• Number of (OR percentage 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 for consultation and with community partners at any time before the end of 6 months.

  up to 6 months

• Percentage of eligible participants who consented to be in study

  This is to measure interest and the need for help by the intervention that can provide caregiver / patient financial education and navigation

  Up to 6 months

Secondary Outcomes (1)

• Personal Financial Wellness Scale (PFWS) / Comprehensive Score of Financial Toxicity (COST measure)

  Baseline, 6-months

Study Arms (1)

Needs Navigation Intervention

EXPERIMENTAL

Individuals who screen positive will all move forward to receive this intervention. This includes connection to community partners with financial education and easily accessible resources, and a vocational navigation and support consultation for caregivers for 6-months.

Behavioral: Needs navigation intervention

Interventions

Needs navigation intervention BEHAVIORAL

The investigator anticipates that this will include a baseline financial, education and vocational assessment, likely using a virtual platform. Participants who screen positive will be connected to community resources and for consultation. There will be a 1-month, 3-month and 6-month check-in to address any financial concerns through additional counseling/navigation.

Needs Navigation Intervention

Eligibility Criteria

• Age: 15 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• AYA patient participants:
• Age 15 - 26 years old
• English or Spanish-speaking
• In between 3-months of diagnosis of cancer date and up to 1-year post-treatment completion without progression or recurrence of cancer
• 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:

• Dyad with caregiver or younger AYA that previously participated in study AAAU2405
• Unable to complete financial survey questions or contraindicated (as outlined in Protection of Human Subjects)
• Dyad with younger AYAs who are enrolled on hospice or receiving other end-of-life care

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (10)

• 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

• Ramsey SD, Bansal A, Fedorenko CR, Blough DK, Overstreet KA, Shankaran V, Newcomb P. Financial Insolvency as a Risk Factor for Early Mortality Among Patients With Cancer. J Clin Oncol. 2016 Mar 20;34(9):980-6. doi: 10.1200/JCO.2015.64.6620. Epub 2016 Jan 25.

  PMID: 26811521 BACKGROUND

• Parsons SK, Keegan THM, Kirchhoff AC, Parsons HM, Yabroff KR, Davies SJ. Cost of Cancer in Adolescents and Young Adults in the United States: Results of the 2021 Report by Deloitte Access Economics, Commissioned by Teen Cancer America. J Clin Oncol. 2023 Jun 10;41(17):3260-3268. doi: 10.1200/JCO.22.01985. Epub 2023 Feb 24.

  PMID: 36827624 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

• Guy GP Jr, Yabroff KR, Ekwueme DU, Smith AW, Dowling EC, Rechis R, Nutt S, Richardson LC. Estimating the health and economic burden of cancer among those diagnosed as adolescents and young adults. Health Aff (Millwood). 2014 Jun;33(6):1024-31. doi: 10.1377/hlthaff.2013.1425.

  PMID: 24889952 BACKGROUND

• Shah K, Zafar SY, Chino F. Role of financial toxicity in perpetuating health disparities. Trends Cancer. 2022 Apr;8(4):266-268. doi: 10.1016/j.trecan.2021.12.007. Epub 2022 Jan 13.

  PMID: 35034866 BACKGROUND

• Beauchemin MP, Solomon S, Michaels CL, McHenry K, Turi E, Khurana R, Sanabria G. Toward identification and intervention to address financial toxicity and unmet health-related social needs among adolescents and emerging adults with cancer and their caregivers: A cross-cultural perspective. Cancer Med. 2024 Apr;13(8):e7197. doi: 10.1002/cam4.7197.

  PMID: 38659403 BACKGROUND

• Beauchemin MP, DeStephano D, Raghunathan R, Harden E, Accordino M, Hillyer GC, Kahn JM, May BL, Mei B, Rosenblat T, Law C, Elkin EB, Kukafka R, Wright JD, Hershman DL. Implementation of Systematic Financial Screening in an Outpatient Breast Oncology Setting. JCO Clin Cancer Inform. 2023 Mar;7:e2200172. doi: 10.1200/CCI.22.00172.

  PMID: 36944141 BACKGROUND

MeSH Terms

Conditions

Neoplasms

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: February 29, 2024
• First Posted: March 6, 2024
• Study Start: February 16, 2024
• Primary Completion: July 31, 2026
• Study Completion: July 31, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (1)