Khurana Rhea K, Valera Kathryn, Raghunathan Rohit, Gallagher Kathleen D, Angove Rebekah Sm, Bradshaw Erin, Patton Janet, Alvarado Sabrina, Crespo Stephen, Judon Kimberly, DiCola Katie, Steinberg Dara M, Wang Shikun, Hershman Dawn L, Beauchemin Melissa P
School of Nursing, Columbia University Irving Medical Center, New York, NY, USA.
Herbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center, New York, NY, USA.
Contemp Clin Trials Commun. 2025 Jul 16;47:101523. doi: 10.1016/j.conctc.2025.101523. eCollection 2025 Oct.
Adolescent and young adult (AYA: 15-39 years) cancer survivors face high financial toxicity risk. Addressing unmet health-related social needs (HRSN: financial strain, food, housing, transportation, or utility difficulties) may reduce health and financial disparities. This pilot study examines the feasibility and preliminary impact of a needs navigation intervention (AYA-NAV) for AYAs with cancer who screen positive for financial toxicity or unmet HRSN.
This single-arm study involves 30 AYAs receiving cancer treatment at a large, diverse academic institution. After a baseline assessment to determine eligibility, those screening positive for financial toxicity or unmet HRSN will receive AYA-NAV, including resource provision and hybrid needs navigation via a referral to the Patient Advocate Foundation (PAF) and a digital platform, findhelp.org. Data will be collected at baseline (preintervention), monthly check-ins (months 2-5), and 6-month follow-up (postintervention) through surveys using validated scales to measure financial toxicity, HRSN, quality of life, and implementation outcomes. Feasibility will be evaluated with predetermined acceptability measures.
This protocol assesses the feasibility of AYA-NAV, a hybrid needs navigation intervention for AYAs with cancer. Findings will inform future randomized studies on efficacy and impact. Additionally, this study may guide sustainable community-partnered navigation research to improve cancer care delivery and patient outcomes.
Clinicaltrials.gov registry: NCT06072833. The study was registered on October 3, 2023.
青少年及青年（15 - 39岁）癌症幸存者面临较高的经济毒性风险。满足未得到满足的与健康相关的社会需求（HRSN：经济压力、食品、住房、交通或公用事业困难）可能会减少健康和经济差距。这项试点研究考察了针对筛查出经济毒性或未得到满足的HRSN呈阳性的癌症青少年及青年的需求导航干预措施（AYA - NAV）的可行性和初步影响。
这项单臂研究涉及30名在一家大型多元化学术机构接受癌症治疗的青少年及青年。在进行基线评估以确定 eligibility 后，那些筛查出经济毒性或未得到满足的HRSN呈阳性的患者将接受AYA - NAV，包括通过转介到患者权益倡导基金会（PAF）和数字平台findhelp.org提供资源和混合需求导航。将在基线（干预前）、每月签到（第2 - 5个月）以及6个月随访（干预后）通过使用经过验证的量表进行调查来收集数据，以测量经济毒性、HRSN、生活质量和实施结果。将使用预定的可接受性指标评估可行性。
本方案评估了AYA - NAV的可行性，AYA - NAV是一种针对癌症青少年及青年的混合需求导航干预措施。研究结果将为未来关于疗效和影响的随机研究提供信息。此外，本研究可能会指导可持续的社区合作导航研究，以改善癌症护理服务和患者结局。
Clinicaltrials.gov注册库：NCT06072833。该研究于2023年10月3日注册。
