Needs Navigation for Caregivers of AYAs (Cope-CAYAC)

February 29, 2024 updated by: Melissa Beauchemin, Columbia University

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
        • Contact:
          • Melissa Beauchemin, PhD, MSN,CPNP-PC, CPO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Needs Navigation Intervention
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of (OR percentage of) participants who completed the intervention
Time Frame: up to 6 months
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.
up to 6 months
Percentage of eligible participants who consented to be in study
Time Frame: Up to 6 months
This is to measure interest and the need for help by the intervention that can provide caregiver / patient financial education and navigation
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Personal Financial Wellness Scale (PFWS) / Comprehensive Score of Financial Toxicity (COST measure)
Time Frame: Baseline, 6-months
The PFWS/ COST is a participant-reported outcome measure that describes financial distress in cancer patients or their caregivers.
Baseline, 6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

February 29, 2024

First Submitted That Met QC Criteria

February 29, 2024

First Posted (Actual)

March 6, 2024

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AAAU9477

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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