Navigating Financial and Health-Related Social Needs in Adolescent and Young Adult Cancer Survivors (AYA-NAV) (AYA-NAV)

July 29, 2025 updated by: Melissa Beauchemin, Columbia University

Navigating Financial and Health-Related Social Needs in Adolescent and Young Adult Cancer Survivors (AYA-NAV): A Digital Intervention Pilot Study

Aim 1: Refine the HRSN navigation model to integrate a digital platform (Findhelp.org) to meet the needs of AYAs. The investigators will conduct iterative co-design sessions with AYAs and caregivers to understand their views on the existing Findhelp.org website and the likely need for other human-to-human and digital strategies to augment platform engagement (e.g., text reminders) and to address vocational needs.

Aim 2: Evaluate the feasibility and acceptability of the refined hybrid intervention that includes digital + person-to-person HRSN navigation.

Aim 3: Explore the preliminary impact of the refined hybrid intervention, compared to elevated usual care (a one-time referral to FindHelp.org alone), on reduction in financial distress (AYA and caregiver) and on AYA global health (i.e., mental, social, physical).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Nearly 90,000 adolescent and young adults (AYA: defined by the National Cancer Institute [NCI] as age 15-39 years) are diagnosed with cancer annually in the United States (US), 85% of whom are expected to become long-term survivors. Compared to their peers, these survivors have an increased burden of chronic health conditions. AYAs also face devastating financial toxicity, defined as the negative personal financial impact of healthcare costs, resulting not only from the cost of care, but also from interrupted education, exclusion from the workforce, and developmental disruption in achieving or maintaining independence. In fact, AYA cancer survivors experience disproportionately higher rates of financial toxicity and unemployment, associated with poorer overall survival and bankruptcy, compared to older cancer survivors. Among AYA survivors, those with public insurance, who live in areas of high deprivation, and/or who are Black or Hispanic/Latino (hereafter Hispanic) have lower rates of 5- and 10-year survival, likely due in part to adverse social determinants of health (SDOH) and unmet health-related social needs (HRSN: financial strain, food insecurity, un/underinsurance, unstable housing, and suboptimal education).

The research team has studied financial toxicity and HRSN among Spanish- and English-preferring AYAs and their caregivers to develop participant-informed interventions to address unmet HRSN. This study is pilot testing a needs navigation model, adapted from an adult-directed model, among Spanish- and English-speaking AYAs who screen positive for high financial toxicity or unmet HRSN and are receiving care at Columbia University Irving Medical Center (CUIMC) in New York City. This model includes tailored needs navigation delivered over 6 months by a community organization that provides telephone-based case management to people facing life-limiting illness. Though AYA participants are initially interested in this AYA-HRSN navigation model (consent rates >85%), uptake and sustained engagement are rarely observed. During monthly check-ins with participants, investigators identified two gaps in the current model. First, AYAs do not perceive the model to be acceptable in addressing their needs because it is not accessible digitally. Findhelp.org is an established, digital network of local resources that can be leveraged to address this gap. Second, AYAs and caregivers request support to address educational and vocational needs, a resource not available through our community partner. Informed by these preliminary findings and given that AYAs are digital experts, the objective of this R21 proposal is to adapt the needs navigation model to a digital platform, while adding vocational navigation, to better engage AYAs and address their unmet HRSN. Using mixed methods, the investigators will refine the intervention (Aim 1) and conduct a randomized pilot study to measure its feasibility and acceptability (Aim 2) and compare the impact of the digital HRSN navigation intervention with elevated usual care (Aim 3). This study will enroll and randomize (1:1) 80 English- and Spanish-speaking AYAs who are within 6 months of completing curative-intent cancer treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Aim 1:

  • AYAs (age 18-39) who have/had a diagnosis of cancer are eligible to participate.
  • English or Spanish-speaking

Aim 2 and 3:

  • AYAs (age 15-39) who were diagnosed with cancer or began treatment for cancer within the past 6 months, or those who are still on first treatment for cancer (non-relapse)
  • English or Spanish-speaking
  • For AYAs who are < 18 years, caregiver participation will be required; for AYAs > 18 years, caregivers may co-participate if desired; the primary unit of focus is the AYA patient.

Exclusion Criteria:

  • Dyad with caregiver or younger AYA that previously participated in study AAAU2405 or AAAY9477
  • 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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AYA-NAV

Stratified by age (15-25 years and 26-39 years). Participants will receive the following intervention components:

  1. A voucher to provide nominal support for immediate needs
  2. A standard resource sheet that has been co-developed with the social work team at CUIMC and lists available community resources for people living with cancer
  3. Direct support from the study team to set up their Findhelp.org account and to navigate through the available resources
  4. A 3-month check-in session with the study team by telephone, text message, or directly through findhelp.org
  5. A referral option to the Patient Advocate Foundation for individualized case management services
  6. If the participant reports educational/vocational needs, they will receive person-to-person vocational navigation and support consultation, which will provide referrals and navigation support to educational resources.

The 6-month study survey will include implementation outcomes and optional interview.
Behavioral: AYA-NAV
Support for AYA and vocational navigation sessions from clinical team
No Intervention: Enhanced Usual Care
Stratified by age (15-25 years and 26-39 years). Participants will receive information on Findhelp.org and a resource sheet. Follow-up surveys will be administered at 6 months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment rate (feasibility)
Time Frame: Up to 6 months
Percent eligible out of total screened
Up to 6 months
Consent rate (feasibility)
Time Frame: Up to 6 months
Percent consented out of eligible total
Up to 6 months
Retention rates (feasibility)
Time Frame: Up to 6 months
Percent of enrolled that completed the 6-month assessment
Up to 6 months
Comprehensive Score of Financial Toxicity (COST) score
Time Frame: baseline, 6-months
The COST is a patient-reported outcome measure that describes the financial distress experienced by cancer patients. It is a 11-item questionnaire with a score range of 0-44. Lower COST values indicate higher toxicity. Higher scores indicate lower financial toxicity.
baseline, 6-months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patterns of engagement
Time Frame: Up to 6 months
Engaged with an intervention component at least once
Up to 6 months
Implementation outcomes
Time Frame: 6 months
12-item AIM/IAM/FIM (Acceptability of Intervention Measure; Intervention Appropriateness Measure; Feasibility of Intervention Measure). Each item gets a score of 1-5. A higher score indicates greater acceptability, appropriateness, or feasibility.
6 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Mental Health Measure
Time Frame: Baseline, 6-months
PROMIS Global Health measure. Quality of Life Measure (scale 1-5; higher number indicating better QoL)
Baseline, 6-months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Connor Davidson Resilience Scale (CD-RISC)
Time Frame: Baseline, 6-months
Resiliency measure. Total score ranges 0-40. Higher score indicates higher resiliency.
Baseline, 6-months
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical Health
Time Frame: Baseline, 6-months
PROMIS Global Health measure. Quality of Life Measure (Scale 1-5; higher number indicates better quality of life;
Baseline, 6-months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 23, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAAV3629
  • R21NR021310 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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