Telehealth Based Synchronous Navigation to Improve Molecularly-Informed Care for Patients With Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Molecularly-informed Treatment Recommendations
研究概览
简要总结
The goal of this trial is to design and test a telehealth nurse navigation intervention for patients with suspected locally advanced/metastatic NSCLC to improve timely molecularly-informed treatment recommendations through early integration of concurrent molecular testing.
详细描述
The overarching goal of this pilot trial is to design and test a nurse navigation intervention delivered via telehealth for patients with suspected locally advanced/metastatic NSCLC to improve timely molecularly-informed treatment recommendations through early integration of concurrent molecular testing (i.e., tumor tissue and plasma-based molecular testing or plasma only when tumor tissue is insufficient/unavailable). The central hypothesis is that providing telehealth nurse navigation to support completion of concurrent molecular testing will result in higher rates of comprehensive testing, improved timeliness of molecularly-informed treatment recommendations (primary endpoint), earlier initiation of molecularly-informed treatment, more meaningful patient-clinician communication, and higher levels of overall satisfaction among patients and clinicians. Drawing from systematic evidence on the role of navigation for coordination of cancer care and informed by insights from communication science and behavioral economics, the specific telehealth strategy to be tested is synchronous telehealth nurse navigation in combination with default ordering of plasma-based testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, 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
- •Aged 18 years or older
- •Based on cross-sectional imaging, suspected to have locally advanced/metastatic NSCLC (as determined by the evaluating clinician)
- •Scheduled for an appointment in the lung cancer evaluation clinic
排除标准
- •Are not suspected to have locally advanced/metastatic NSCLC
- •Have a concurrent active malignancy
结局指标
主要结局
Molecularly-informed Treatment Recommendations
时间窗: Measured up to 12 weeks from randomization
Receipt of a molecularly-informed treatment recommendation for patients with metastatic NSq NSCLC at the time of the patient's initial oncology visit.
次要结局
- Rate of Telehealth Visit Completion(Measured up to 3 weeks from randomization)
- Proportion of Patients With Diagnosis Other Than Metastatic Nonsquamous NSCLC (Telehealth Arm Only)(Measured at 12 weeks from randomization)
- Rate of Completion of Comprehensive Molecular Testing (Tissue and/or Plasma Testing) Prior to Initiation of First Line Therapy(Measured up to 12 weeks from randomization)
- Identification of One or More Targetable Mutations(Measured up to 12 weeks from randomization)
- Timeliness of Molecularly-informed Treatment Recommendation(Measured up to 12 weeks from randomization)
- Overall Survival(Measured up to 1 year from the time of randomization to death from any cause)
- Time From Randomization to Treatment Initiation(Measured at 12 weeks from randomization)
研究者
Charu Aggarwal
Associate Professor of Medicine
Abramson Cancer Center at Penn Medicine