针对青少年和年轻癌症患者的财务和健康相关社会需求导航干预（AYA-NAV）的试点可行性：一项前瞻性单臂研究的研究方案

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-07-16 DOI:10.1016/j.conctc.2025.101523

Rhea K. Khurana , Kathryn Valera , Rohit Raghunathan , Kathleen D. Gallagher , Rebekah SM. Angove , Erin Bradshaw , Janet Patton , Sabrina Alvarado , Stephen Crespo , Kimberly Judon , Katie DiCola , Dara M. Steinberg , Shikun Wang , Dawn L. Hershman , Melissa P. Beauchemin

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引用次数: 0

摘要

青少年和年轻成人（AYA: 15-39岁）癌症幸存者面临很高的财务毒性风险。解决未满足的与健康相关的社会需求（HRSN：财政紧张、食物、住房、交通或公用事业困难）可能会减少健康和财务差异。本初步研究探讨了需求导航干预（AYA-NAV）对财务毒性或未达到HRSN的癌症aya患者的可行性和初步影响。方法：本单臂研究纳入了30名在大型多元化学术机构接受癌症治疗的aya。在基线评估确定资格后，那些财务毒性筛查阳性或HRSN未达到的患者将获得AYA-NAV，包括通过转介到患者倡导基金会（PAF）和数字平台findhelp.org提供资源提供和混合需求导航。数据将在基线（干预前）、每月检查（2-5个月）和6个月随访（干预后）通过使用有效量表的调查收集，以测量财务毒性、HRSN、生活质量和实施结果。可行性将以预先确定的可接受性措施进行评估。本方案评估了AYA-NAV的可行性，这是一种用于癌症aya的混合需求导航干预。研究结果将为未来的疗效和影响的随机研究提供信息。此外，本研究可以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预后。临床试验。gov注册：NCT06072833。该研究于2023年10月3日注册。

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Pilot feasibility of a financial and health-related social needs navigation intervention (AYA-NAV) for adolescents and young adults with Cancer: Study protocol for a prospective, single-arm study

Background

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.

Methods

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.

Discussion

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.

Trial registration

Clinicaltrials.gov registry: NCT06072833. The study was registered on October 3, 2023.

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.