Clinical trial · Interventional
Needs Navigation for Caregivers of AYAs
Leveraging COmmunity Partnered nEeds Navigation to Reduce Unmet Health-related Social Needs Among Caregivers for Adolescent and Younger Adult Cancer Survivors
NCT06296641CI-TRIAL-00124674Cope-CAYACcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer in Adolescence | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Needs navigation intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Needs Navigation Intervention
- description
- 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.
- interventionNames
- Behavioral: Needs navigation intervention
Primary outcomes (2)
- measure
- Number of (OR percentage of) participants who completed the intervention
- timeFrame
- up to 6 months
- description
- 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.
- measure
- Percentage of eligible participants who consented to be in study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 26 Years
Show eligibility criteria text
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 Exclusion Criteria: * 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
References
Publications (10)
- BACKGROUNDZafar 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
- BACKGROUNDAltice 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
- BACKGROUNDYabroff 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
- BACKGROUNDRamsey 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
- BACKGROUNDParsons 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
- BACKGROUNDDanhauer 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.