Needs Navigation for Caregivers of AYAs (Cope-CAYAC)

Columbia University

Status: Suspended

Conditions: Cancer in Adolescence

Treatments: Behavioral: Needs navigation intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06296641

AAAU9477

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 15 to 26 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Needs Navigation Intervention

Experimental group

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.

Treatment:

Behavioral: Needs navigation intervention