A Stepped Wedge Cluster Randomized Trial Comparing a Navigation-Based Multilevel Intervention With Treatment as Usual to Improve Initiation of Timely Postoperative Radiation Therapy in Adults With Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 532
- 试验地点
- 8
- 主要终点
- Initiation of Timely PORT
研究概览
简要总结
The goal of this clinical trial is to compare the effectiveness of a navigation-based multilevel intervention (ENDURE) with treatment as usual (TAU) to improve the initiation of guideline-adherent postoperative radiation therapy among patients with head and neck cancer. The main questions the trial aims to answer are:
- Does ENDURE improve initiation of timely PORT relative to treatment as usual?
- What are the mechanisms through which ENDURE improves timeliness to treatment?
- What are the barriers and facilitators to the implementation of ENDURE into routine clinical care?
详细描述
In this hybrid type 1 effectiveness-implementation study, the investigators will conduct a stepped-wedge cluster randomized trial with cancer centers (n=4; 484 patients) randomized to sequentially deliver treatment as usual (TAU) then ENDURE to patients with head and neck cancer undergoing surgery and postoperative radiation therapy (PORT). The trial will assess the effect of ENDURE vs TAU on improving initiation of timely PORT (primary objective) and the underlying mechanisms of ENDURE (secondary objective). The investigators will concurrently conduct a mixed-methods study with quantitative measures of implementation outcomes and qualitative data about implementation determinants from semi-structured interviews with key stakeholders and site visits (exploratory objective).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Age >/= 18 years
- •Squamous cell carcinoma (SCC) (or histologic variant) of the oral cavity, oropharynx, hypopharynx, larynx, unknown primary, paranasal sinuses, or nasal cavity
- •American Joint Committee on Cancer (AJCC) 8th edition clinical T3-4 or >N1 SCC of the oral cavity, oropharynx, hypopharynx, larynx, paranasal sinuses, nasal cavity, or unknown primary.
- •No history of radiation therapy for treatment of HNSCC in the definitive or adjuvant settings that would, at the discretion of the enrolling clinician, affect the patient's need for adjuvant RT.
- •Plan for curative intent surgery at one of the participating centers
- •Plan for PORT (regardless of whether it is at the surgical center) with or without concurrent chemotherapy following curative intent surgery based on the expectation of at least one of the following adverse features on final pathologic evaluation: pT3 or pT4 primary, N1 or greater nodal disease, perineural invasion (PNI), or lymphovascular invasion (LVI).
排除标准
- •Inability to speak or read English or Spanish.
- •Severe mental illness that would prevent trial participation.
- •HPV-positive OPC or unknown primary SCC staged as cT1-2N1 with a single ipsilateral LN < 3 cm
- •Synchronous untreated malignancy expected to impact life expectancy
结局指标
主要结局
Initiation of Timely PORT
时间窗: 3 months
The initiation of PORT \> 6 weeks (42 days) following definitive surgery for HNSCC.
次要结局
- Time-to-PORT(4 months)
- Pre-radiation therapy dental extractions(1 month)
- Pre-Surgical consultation with radiation oncology(1 month)
- Time to postoperative scheduling with radiation oncology(3 months)
- Time to postoperative appointment with radiation oncology(3 months)
研究者
Evan Graboyes
Associate Professor-Faculty
Medical University of South Carolina