Implementing the NYU Electronic Patient Visit Assessment (ePVA) for Head and Neck Cancer In Rural and Urban Populations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 10
- 主要终点
- Head and neck cancer (HNC) symptoms as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)
研究概览
简要总结
The PI and the research team developed the New York University (NYU) Electronic Patient Visit Assessment (ePVA) for head and neck cancer (HNC) as a patient-reported outcome measure (PRO) for the early detection of uncontrolled symptoms. The ePVA is digital patient-reported symptom monitoring system, providing actionable information at point-of-care that enables clinicians to provide real-time interventions. The study aims to advance the science of cancer care delivery by testing the effectiveness of the ePVA as a digital patient-reported monitoring system for patients with HNC in real-world settings and identify implementation strategies that optimize the effectiveness of the ePVA in diverse rural and urban settings. The study hypothesis is that participants assigned to the ePVA arm will have better swallowing, taste and smell, and social function than participants assigned to usual care arm at 4 weeks after completing radiation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(Patient Participants):
- •Individuals with histologically diagnosed head and neck cancer (HNC) undergoing curative radiation therapy with or without chemotherapy
- •English or Spanish speaking
- •Inclusion Criteria (Clinician Participants):
- •Clinicians (i.e., physicians, nurses, dentists, physician assistants, social workers, nutritionists, speech swallow therapists) caring for patients with head and neck cancer at the participating institutions
排除标准
- •(Patient and Clinician Participants):
- •Any medical condition that could limit the participant's ability to provide informed consent and complete the questionnaires.
研究组 & 干预措施
NYU Electronic Patient Visit Assessment (ePVA) plus Usual Care
干预措施: NYU Electronic Patient Visit Assessment (ePVA) (Behavioral)
NYU Electronic Patient Visit Assessment (ePVA) plus Usual Care
干预措施: Usual Care (Behavioral)
Usual Care
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Head and neck cancer (HNC) symptoms as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)
时间窗: 4 weeks after completing radiation therapy
The EORTC QLQ-C30 and QLQ-H\&N35 will be used to measure head and neck cancer symptoms, such as social function, senses of taste and smell, and swallowing. The scores will be summed and then transformed to a single score ranging from 0=Best to 100=Worst.
次要结局
- Pain as assessed by EORTC QLQ-H&N35 Quality of Life Questionnaire (QLQ)(4 weeks after completing radiation therapy)
- Health-Related Quality of Life (HRQoL) as assessed by the EORTC QLQ-C30 Quality of Life Questionnaire (QLQ)(4 weeks after completing radiation therapy)
- Acute Care Services Use as assessed by number of acute care visits(4 weeks after completing radiation therapy)
- Acute Care Services Use as assessed by number of days of using acute care(4 weeks after completing radiation therapy)
研究者
Janet Van Cleave
Associate Professor
The University of Texas Health Science Center, Houston