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

NCT06950983 | Recruiting

• 2 other identifiers: AAAV3629R21NR021310
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Cancer in Adolescence

Keywords

Cancer; Adolescents; Young adults; Financial needs; Social needs

Outcome Measures

Primary Outcomes (4)

• Recruitment rate (feasibility)

  Percent eligible out of total screened

  Up to 6 months

• Consent rate (feasibility)

  Percent consented out of eligible total

  Up to 6 months

• Retention rates (feasibility)

  Percent of enrolled that completed the 6-month assessment

  Up to 6 months

• 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.

  baseline, 6-months

Secondary Outcomes (3)

• Patterns of engagement

  Up to 6 months

• Implementation outcomes

  6 months

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

  Baseline, 6-months

Other Outcomes (2)

• Connor Davidson Resilience Scale (CD-RISC)

  Baseline, 6-months

• Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical Health

  Baseline, 6-months

Study Arms (2)

AYA-NAV

EXPERIMENTAL

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

Enhanced Usual Care

NO 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.

Interventions

AYA-NAV BEHAVIORAL

Support for AYA and vocational navigation sessions from clinical team

AYA-NAV

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

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

CONTACT

212-342-4111; mmp2123@cumc.columbia.edu

Rhea Khurana, BS

CONTACT

9173970773; rk3320@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Nursing

Model Details: Focus groups for aim 1. Parallel study model for aim 2 and 3

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: April 30, 2025
• Study Start: July 23, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

US (1)