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Cancer in AdolescenceAYA-NAVNCT06950983

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

A study testing AYA-NAV in people with Cancer in Adolescence, run by Columbia University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 15 years and olderHealthy volunteers can take part
Conditions the study is for
Cancer in Adolescence
What is being tested?
AYA-NAV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
23 Jul 2025to 31 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Melissa Beauchemin, PhD, MSN,CPNP-PC, CPO contact

212-342-4111

mmp2123@cumc.columbia.edu

Rhea Khurana, BS contact

9173970773

rk3320@cumc.columbia.edu

United States1 site, 1 recruiting
  • Columbia University Irving Medical Center

    New York, New York, 10032

    Melissa Beauchemin, PhD, MSN,CPNP-PC, CPO

    Recruiting

Other trials in United States

About this study

Official title: 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).

Read the 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.

Being tested
AYA-NAV
Keywords
Cancer, Adolescents, Young adults, Financial needs, Social needs
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AYA-NAVBehavioural

    Support for AYA and vocational navigation sessions from clinical team

Study groups in NCT06950983
Study groupRoleWhat they receive
AYA-NAVExperimentalStratified 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.
Receives: Behavioral: AYA-NAV
Enhanced Usual CareNo interventionStratified 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 being measured

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

  1. Recruitment rate (feasibility)

    Percent eligible out of total screened

    Measured: Up to 6 months

  2. Consent rate (feasibility)

    Percent consented out of eligible total

    Measured: Up to 6 months

  3. Retention rates (feasibility)

    Percent of enrolled that completed the 6-month assessment

    Measured: Up to 6 months

  4. Comprehensive Score of Financial Toxicity (COST) score

    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.

    Measured: baseline, 6-months

Secondary outcomes (3)
  1. Patterns of engagement

    Engaged with an intervention component at least once

    Measured: Up to 6 months

  2. Implementation outcomes

    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.

    Measured: 6 months

  3. Patient-Reported Outcomes Measurement Information System (PROMIS) Global Mental Health Measure

    PROMIS Global Health measure. Quality of Life Measure (scale 1-5; higher number indicating better QoL)

    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 posted30 Apr 2025
  2. Study start23 Jul 2025
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Focus groups for aim 1. Parallel study model for aim 2 and 3
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06950983
Sponsor's protocol ID
AAAV3629
Other IDs
R21NR021310
Acronym
AYA-NAV
Status last verified
Jul 2026
First submitted
5 Mar 2025
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing AYA-NAV 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 7 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: looking for participants now, as of the sponsor's last update on 23 Jul 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Melissa Beauchemin, PhD, MSN,CPNP-PC, CPO (212-342-4111, mmp2123@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate (feasibility) (time frame: Up to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 23 Jul 2026.

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