A Randomized Comparative Study of a Weekly Versus Every Other Week Nurse Practitioner-led Symptom Management Clinic for Head and Neck Cancer Patients Undergoing Concurrent Chemotherapy and Radiation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Percentage of Patients that Experience a "Problem" during Cancer Treatment
研究概览
简要总结
A retrospective chart review of patients receiving concurrent chemoradiotherapy for oropharynx cancer was performed to compare clinical data for patients treated prior to the initiation of the NP clinic with those subsequently seen weekly in the NP clinic. The variables studied included; rate of hospitalization, dose completion and dose reductions. The results revealed an overall improvement in all variables for those patients seen in the weekly NP clinic.
To further analyze this data a randomized, prospective study is proposed to validate the findings of the retrospective study. It is predicted that a weekly NP led clinic will decrease costly hospitalizations, increase patient treatment completion and improve overall patient quality of life and satisfaction.
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
- 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
- •Have a diagnosis of stage III or IV HNC
- •Are initiating concurrent chemotherapy and radiation
- •Are able and willing to sign informed consent
- •Ages 18 years or older
- •ECOG (Eastern Cooperative Oncology Group) score of 0 or 1 (The ECOG score attempt to quantify cancer patients' general well-being and activities of daily life)
- •Able to read and complete the required survey
排除标准
- •Cannot provided informed consent
- •Any medical or psychiatric illness which in the opinion of the principal investigator would compromise the patient's ability to tolerate this treatment.
- •Have a history of prior cancer within past 5 years (excluding non-melanoma skin cancer)
- •Are unwilling or unable to complete the required QOL (Quality of Life) survey
结局指标
主要结局
Percentage of Patients that Experience a "Problem" during Cancer Treatment
时间窗: 11 weeks
A "problem" includes any one of three events: dose reduction, inability to complete treatment, or toxicity related hospitalization. Patients are assigned a 1 if any of these events occurs at least once during treatment or are assigned 0 if they complete treatment with no dose reductions or toxicity related hospitalizations. When data is analyzed and reported, the problem rate will be summarized along with the each individual negative component.
次要结局
未报告次要终点