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

Trial Summary

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 safety data exists for AYA-NAV in 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 challenges and long-term health outcomes of adolescent and young adult cancer survivors, but do not mention specific safety evaluations for AYA-NAV. ^{1 2 3 4 5}

How is the AYA-NAV treatment different from other treatments for young adult cancer survivors?

The AYA-NAV treatment is unique because it specifically addresses the comprehensive follow-up care needs of adolescent and young adult cancer survivors, focusing on their high risk for late effects of cancer-directed therapy. Unlike standard treatments, it emphasizes personalized survivorship care, considering the unique medical and psychosocial needs of this age group. ^{2 6 7 8 9}

What is the purpose of this trial?

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).

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Knowledge of Required Medical Surveillance Among Adolescent and Young Adult Survivors of Childhood Cancer. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Is the Adolescent and Young Adult Cancer Survivor at Risk for Late Effects? It Depends on Where You Look. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Research challenges in adolescent and young adult cancer survivor research. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Survivorship in adolescents and young adults. [2014]

5. United States pubmed.ncbi.nlm.nih.gov

Prevalence of Adverse Event Reporting in Adolescents and Young Adults Enrolled in Cancer Clinical Trials. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Adolescent and young adult cancers: unmet needs and closing the gaps. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Assessing the health care needs of adolescent and young adult cancer patients and survivors. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Children's Oncology Group's 2013 blueprint for research: adolescent and young adult oncology. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Adolescent and Young Adult Oncology, Version 2.2018, NCCN Clinical Practice Guidelines in Oncology. [2022]