Needs Navigation for Caregivers of AYAs

Официальное название

Leveraging COmmunity Partnered nEeds Navigation to Reduce Unmet Health-related Social Needs Among Caregivers for Adolescent and Younger Adult Cancer Survivors

Обзор

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.

Подробное описание

Financial toxicity, the negative personal financial impact of healthcare, is a highly prevalent adverse effect of cancer treatment, and AYA cancer survivors experience disproportionately higher rates of financial toxicity compared to older cancer survivors. Financial toxicity is associated with poorer overall survival and bankruptcy, and AYA survivors are 10 times more likely to file for bankruptcy than older cancer survivors. Thus, financial toxicity and unmet HRSN (health-related social needs) are key contributors to employment and health outcome disparities seen among AYA survivors living in areas of persistent poverty.

The study team has focused on addressing unmet HRSN and reducing outcome disparities among AYA cancer survivors, many of whom live in areas of persistent poverty. The investigators have adapted a model of financial navigation that reduces financial toxicity among older adults with cancer, informed by qualitative research among Spanish- and English-speaking AYAs and their caregivers from the local community. The investigators have identified community and clinical partners poised to address these unique unmet needs. These partners have expertise in educational navigation and caregiver community resources - both cited as unmet needs in our pilot study. Using mixed methods, this study will refine (Aim 1 - already completed) and pilot test (Aims 2 and 3) a tailored version of the intervention among 30 English and Spanish-speaking caregivers of younger AYAs who screen positive for severe financial toxicity or unmet HRSN. Aim 3 will also be achieved by having caregivers complete qualitative and quantitative assessments measured at baseline, 3 and 6 months to identify factors that are associated with financial toxicity. Qualitative data will be collected from participants in this study as well as participants from our AYA-NAV trial to better understand these factors and explore AYAs/Caregiver perception on screening for school-based needs and educational guidance sessions.

Вмешательства

• Поведенческое Needs navigation intervention
  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.

Первичные конечные точки

• Number of (OR percentage of) participants who completed the intervention [Срок оценки: up to 6 months]
• Percentage of eligible participants who consented to be in study [Срок оценки: Up to 6 months]

Вторичные конечные точки (1)

• Personal Financial Wellness Scale (PFWS) / Comprehensive Score of Financial Toxicity (COST measure) [Срок оценки: Baseline, 6-months]

Критерии участия

Inclusion Criteria: We are enrolling dyads (AYA and caregivers) for this study.

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Columbia University Irving Medical Center — New York

Публикации

• 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
• 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
• 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 D PMID 26644532
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06296641 · AAAU9477

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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