AYA-NAV for Young Adult Cancer Survivors

(AYA-NAV Trial)

Overseen By Rhea Khurana, BS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Previous study participation, Hospice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new support program called AYA-NAV for young adults who have had cancer, aiming to ease financial stress and improve overall health. The program combines online resources with personal assistance, such as setting up accounts on Findhelp.org and providing guidance for educational and vocational needs. Participants may receive direct support and check-ins over several months to evaluate the program's effectiveness compared to using the website alone. Suitable candidates are young adults aged 15-39 who have been diagnosed with cancer or started treatment within the last six months and speak English or Spanish. As an unphased trial, this study offers a unique opportunity to access innovative support resources and contribute to research that could benefit future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the AYA-NAV intervention is safe for young adult cancer survivors?

Research shows no specific safety information is available for AYA-NAV, the treatment under study in this trial. Sources do not provide details about side effects or how well individuals tolerate this type of treatment.

However, this trial does not test a new drug or invasive treatment. Instead, it aims to improve and test a support program for young adult cancer survivors, which is generally considered low-risk. These programs usually address social and financial needs and typically do not raise major safety concerns.

Although direct safety data is lacking, the trial's design suggests the treatment is likely safe, as it involves offering support and resources rather than administering drugs or performing medical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AYA-NAV approach for young adult cancer survivors because it offers personalized support that goes beyond traditional care. Unlike standard options, which typically focus on medical treatment alone, AYA-NAV provides a comprehensive support system, including vouchers for immediate needs, a co-developed resource sheet with community resources, and hands-on assistance with navigating these resources through Findhelp.org. Additionally, it offers a human touch with a 3-month check-in and personalized vocational support, aiming to address the diverse challenges young survivors face. This holistic and individualized approach has the potential to significantly improve the quality of life and long-term outcomes for young adults post-cancer treatment.

What evidence suggests that the AYA-NAV intervention could be effective for young adult cancer survivors?

Research has shown that AYA-NAV, a program designed to assist young cancer survivors, is promising. In this trial, participants will receive the AYA-NAV intervention, which includes personalized support and regular check-ins to address financial and social challenges. These survivors often face mental and physical health struggles, and AYA-NAV aims to improve their well-being by connecting them to helpful resources. Meanwhile, participants in the Enhanced Usual Care arm will receive information on Findhelp.org and a resource sheet. Although the full benefits of AYA-NAV are still under study, early results are encouraging. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adolescent and young adult cancer survivors who are navigating financial and health-related social needs. Specific eligibility criteria details are not provided, but typically participants would need to be within a certain age range and have a history of cancer.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 6 months

Intervention

Participants receive a digital and person-to-person HRSN navigation intervention, including a voucher, resource sheet, and support for setting up Findhelp.org account.

6 months

Monthly check-ins via telephone, text message, or findhelp.org

Follow-up

Participants are monitored for feasibility, acceptability, and impact of the intervention, with surveys administered at 6 months.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• AYA-NAV

Trial Overview The AYA-NAV intervention is being tested, which includes refining a digital platform (Findhelp.org) alongside person-to-person navigation support to help with financial distress and improve overall global health in young cancer survivors.

How Is the Trial Designed?

Group I: AYA-NAV Experimental Treatment 1 Intervention

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.

Group II: Enhanced Usual Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

A review of 182 phase II/III cancer trials published in 2021 found that none reported adverse event (AE) data specifically for adolescents and young adults (AYAs) aged 15-39, making it impossible to assess their treatment tolerance compared to older adults.

The lack of age-specific AE reporting may hinder the optimization of cancer treatments for AYAs, potentially leading to either undertreatment or overtreatment, which could delay improvements in their cancer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of Adverse Event Reporting in Adolescents and Young Adults Enrolled in Cancer Clinical Trials. Wayant, C., Fitzgerald, K., Hemmerich, C., et al.[2023]

Each year, around 26,000 adolescents and young adults in the USA are diagnosed with cancer, and over 80% of them are cured, leading to a growing population of cancer survivors.

These survivors face significant long-term health issues due to treatment side effects, which can lower their quality of life and increase the risk of early death, highlighting the need for targeted screening and prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survivorship in adolescents and young adults. Kishtagari, A., Tavakkoli, M., Park, JH.[2014]

Only 9.5% of adolescent and young adult cancer survivors demonstrated complete knowledge of their required surveillance testing, despite attending a survivorship clinic, indicating a significant gap in awareness.

Younger age at the survivorship visit was linked to better knowledge of testing needs, suggesting that earlier education and follow-up may improve understanding among survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge of Required Medical Surveillance Among Adolescent and Young Adult Survivors of Childhood Cancer. Goode, E., Shah, D., Ver Hoeve, ES., et al.[2022]

There are over 600,000 adolescent and young adult cancer survivors at high risk for late effects from their treatments, highlighting the need for effective survivorship care plans (SCPs).

Current guidelines for AYA cancer survivorship care show significant disagreements on key aspects such as treatment exposure links to late effects and screening protocols, which can complicate follow-up care and impact the quality of life for survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is the Adolescent and Young Adult Cancer Survivor at Risk for Late Effects? It Depends on Where You Look. Barthel, EM., Spencer, K., Banco, D., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5292773/

Health Status of Adolescent and Young Adult Cancer ... A greater proportion of AYA cancer survivors also reported more poor mental and physical health in the past 30 days compared with respondents who had no history ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2832217

Adolescent and Young Adult Cancer Representation in ... This cohort study evaluates the representation of adolescent and young adult patients with cancer in claims research based on continuous ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11194971/

Long-term health outcomes by cancer diagnosed age ... We aimed to examine the social, psychological, and physical well-being of AYA cancer survivors by age at diagnosis using a multinational representative dataset.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2451865425000973

Pilot feasibility of a financial and health-related social ... This pilot study examines the feasibility and preliminary impact of a needs navigation intervention (AYA-NAV) for AYAs with cancer who screen positive for ...

5. link.springer.com link.springer.com/article/10.1007/s11764-024-01597-0

Health-related conditions among long-term cancer ... With 5-year survival rates > 85%, gaining insight into the long-term and late health-related conditions of cancer survivors diagnosed in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9360450/

Cancer-Related Survival Disparities in Adolescent and ... This study found that AYA survivors, during a mean follow-up of 14.5 years, were nearly twice as likely to die from a new cancer than the general population.

7. withpower.com withpower.com/trial/phase-cancer-in-adolescence-4-2025-16767

AYA-NAV for Young Adult Cancer Survivors The research articles do not provide specific safety data for AYA-NAV or similar treatments in young adult cancer survivors. They focus on the general ...

8. healthcaredelivery.cancer.gov healthcaredelivery.cancer.gov/aya/

Adolescent & Young Adult Health Outcomes & Patient ... The adolescent and young adult (AYA) population between the ages of 15 and 39 years has seen little or no improvement in cancer survival rates for decades.

9. jons-online.com jons-online.com/issues/2021/august-2021-vol-12-no-8/understanding-the-needs-of-the-adolescent-and-young-adult-cancer-population

Understanding the Needs of the Adolescent and Young ... Prevalence of AYA Cancer in the United States. In 2020, the United States saw approximately 89,500 new cancer cases and over 9000 cancer deaths among AYAs.