Clinical trial NCT06950983: Navigating Financial and Health-Related Social Needs in Adolescent and Young Adult Cancer Survivors (AYA-NAV)
Official title: Navigating Financial and Health-Related Social Needs in Adolescent and Young Adult Cancer Survivors (AYA-NAV): A Digital Intervention Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer in Adolescence
Keywords: Cancer
Adolescents
Young adults
Financial needs
Social needs
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2025-04-30
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Focus groups for aim 1. Parallel study model for aim 2 and 3
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate (feasibility)
timeFrame: Up to 6 months
measure: Consent rate (feasibility)
timeFrame: Up to 6 months
measure: Retention rates (feasibility)
timeFrame: Up to 6 months
measure: Comprehensive Score of Financial Toxicity (COST) score
timeFrame: baseline, 6-months
Secondary outcomes:
measure: Patterns of engagement
timeFrame: Up to 6 months
measure: Implementation outcomes
timeFrame: 6 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global Mental Health Measure
timeFrame: Baseline, 6-months
Other outcomes:
measure: Connor Davidson Resilience Scale (CD-RISC)
timeFrame: Baseline, 6-months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical Health
timeFrame: Baseline, 6-months
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
References: