Recruiting

Hybrid Intervention

Sponsor:

Columbia University

Code:

NCT06950983

Conditions

Cancer in Adolescence

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Accepted

Interventions

AYA-NAV

Study Details

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

Study ID

NCT06950983

Start date

Jul 23, 2025

Status verified date

Jul, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Interventions

AYA-NAV

Support for AYA and vocational navigation sessions from clinical team

Primary outcome measure

  • Recruitment rate (feasibility) [ Time Frame: Up to 6 months ]
  • Consent rate (feasibility) [ Time Frame: Up to 6 months ]
  • Retention rates (feasibility) [ Time Frame: Up to 6 months ]
  • Comprehensive Score of Financial Toxicity (COST) score [ Time Frame: baseline, 6-months ]

Central Contacts and Locations

Central contacts

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

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

Rhea Khurana, BS

9173970773rk3320@cumc.columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

More Information

Sponsor

Columbia University

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • Cancer
  • Adolescents
  • Young adults
  • Financial needs
  • Social needs

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-07-23.