Single-arm, Phase II Study Evaluating the Clinical Impact of Navigation on Delays and Racial Disparities Starting Postoperative Radiation Therapy for Adults With Locally Advanced Head and Neck Cancer: The NDURE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Percent of Patients With a Delay Starting Post-Operative Radiation Treatment
研究概览
简要总结
This study will evaluate whether a new patient navigation intervention can decrease delays starting post-operative radiation therapy after surgery for white and African-American head and neck cancer patients.
详细描述
This study will evaluate the feasibility, acceptability, preliminary clinical impact, and preliminary behavioral impact of NDURE (Navigation for Disparities and Untimely Radiation thErapy), our multi-level, theory-based navigation intervention to improve timely, equitable post-operative radiation treatment (PORT) among Head and Neck Cancer (HNC) patients. We hypothesize that NDURE will be feasible, acceptable, improve the timeliness of PORT for white and African American (AA) HNC patients and decrease disparities in delay between the two groups by improving system-, interpersonal-, and individual-level health behavior constructs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Percent of Patients With a Delay Starting Post-Operative Radiation Treatment
时间窗: 6 weeks
Percent of patients who start PORT \>6 weeks after surgery. Initiation of postoperative PORT \> 6 weeks after surgery is defined as more than 42 calendar days from the time of the definitive surgical resection to the initiation of radiation therapy. In situations in which the surgical management of the primary tumor and the neck are staged (i.e. occur on two different calendar days), the date of the surgery for the primary tumor will be used. In situations in which an additional surgical resection is required (e.g. re-resection of positive margins to clear residual disease), the date of the earlier (i.e. attempted definitive) surgical procedure will be used to determine the target start date for PORT.
次要结局
- Navigator Caseload(13 months)
- Percent Difference in PORT Delay Between White and AA HNC Patients.(6 weeks)
- Barriers Resolved(12 weeks)
- Navigation Session Completion(12 weeks)
- Median Difference in Time-to-PORT, in Days, Between White and African American HNC Patients(12 weeks)
- Time-to-PORT(12 weeks)
- Percent of Patients With On-time Pre-Radiation Therapy Dental Extractions(12 weeks)
- Percent of Patients With RT Consult Within 10 Days of RT Referral(12 weeks)
- Navigator Time Allocation (Direct)(12 weeks)
- Satisfaction With the Interpersonal Relationship With the Navigator Scale Score(12 weeks)
- Change in Care Transition Measure-15 (CTM-15) Score From Baseline to End-of-study(12 weeks)
- Change in Interpersonal Support Evaluation List-12 (ISEL-12) Score From Baseline to End-of-study(12 weeks)
- Percent of Patients With Referral to PORT Within 10 Days of Surgery(12 weeks)
- Change in Self-Efficacy in Cancer Care Score From Baseline to End-of-study(12 weeks)
- Percentage of Enrolled Participants Who Complete NDURE(13 months)
- Satisfaction With Logistical Aspects of Navigation Scale Score(12 weeks)
- Change in Illness Perception Questionnaire-Revised (IPQ-R) Consequences Subscale Score From Baseline to End-of-study(12 weeks)
- Percent of Patients With Pre-Surgical Radiation Consultation(12 weeks)
- Percent of Patients Surgery to Pathology Reports </= 7 Days(12 weeks)
- Percent of Patients With Initiation of RT Within 21 Days of Consultation(12 weeks)
- Barriers Unresolved(12 weeks)
- Percent of Eligible Participants Who Accrue to NDURE(13 months)
- Change in Perceived Susceptibility Questionnaire Score From Baseline to End-of-study(12 weeks)
- Navigator Time Allocation (Indirect)(12 weeks)
- Change in Perceived Barriers Score From Baseline to End-of-study(12 weeks)
研究者
Evan Graboyes
Assistant Professor, Department of Otolaryngology- Head and Neck Surgery
Medical University of South Carolina