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AzTrials

Cancer in AdolescenceCope-CAYACNCT06296641

Needs Navigation for Caregivers of AYAs

A study testing Needs navigation intervention in people with Cancer in Adolescence, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 26 yearsHealthy volunteers can take part
Conditions the study is for
Cancer in Adolescence
What is being tested?
Needs navigation intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
16 Feb 2024to 28 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

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 26 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

None listed.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Columbia University Irving Medical Center

    New York, New York, 10032

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Being tested
Needs navigation intervention
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.

  • Needs navigation interventionBehavioural

    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.

Study groups in NCT06296641
Study groupRoleWhat they receive
Needs Navigation InterventionExperimentalIndividuals 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.
Receives: Behavioral: Needs navigation intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 6 months

  2. 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

    Measured: Up to 6 months

Secondary outcomes (1)

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

    The PFWS/ COST is a participant-reported outcome measure that describes financial distress in cancer patients or their caregivers.

    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.

  1. First posted6 Mar 2024
  2. Study start16 Feb 2024
  3. Primary completion28 Jun 2026
  4. Study completion28 Jun 2026

Resources

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
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06296641
Sponsor's protocol ID
AAAU9477
Acronym
Cope-CAYAC
Status last verified
Aug 2026
First submitted
29 Feb 2024
Last updated
31 Aug 2026
Results posted
No
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 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.

    PubMed 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 Dec 7.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 35034866

  • 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.

    PubMed 38659403

  • 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.

    PubMed 36944141

Questions about this trial

What is this clinical trial studying?

A study testing Needs navigation intervention 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 0 inclusion and 3 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 31 Aug 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 (OR percentage 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 NCT06296641, which also lists 10 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 31 Aug 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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