Needs Navigation for Caregivers of AYAs

Trial Title: Needs Navigation for Caregivers of AYAs

NCT ID: NCT06296641

Condition: Cancer in Adolescence

Conditions: Keywords:
Cancer
Adolescents
Young adults
Financial needs
Social needs
Minority health
Caregivers

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Participants who screen positive all move forward to receive the intervention

Primary purpose: Health Services Research

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Needs navigation intervention
Description: 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.
Arm group label: Needs Navigation Intervention

Summary: The overall aim of the study is to address unmet health-related social needs and reduce outcome disparities among AYA 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.

Detailed description: Financial toxicity, the negative personal financial impact of healthcare,13 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. Our team has focused on addressing unmet HRSN and reducing outcome disparities among AYA cancer survivors, many of whom live in areas of persistent poverty. We 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 our local community. We 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, we will refine (Aim 1 - already completed) and pilot test (Aims 2 and 3) a tailored version of our intervention among 30 English and Spanish-speaking caregivers of younger AYAs who screen positive for severe financial toxicity or unmet HRSN.

Criteria for eligibility:
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

Gender: All

Minimum age: 15 Years

Maximum age: 26 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Columbia University Irving Medical Center

Address:
City: New York
Zip: 10032
Country: United States

Status: Recruiting

Contact:
Last name: Melissa Beauchemin, PhD, MSN,CPNP-PC, CPO

Start date: February 16, 2024

Completion date: May 2025

Lead sponsor:
Agency: Columbia University
Agency class: Other

Source: Columbia University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06296641