Nurse-Driven Telephone Intervention in Improving Side Effects in Cancer Patients Undergoing Chemotherapy
Evaluating the Feasibility of a Nurse-Driven Telephone Triage Intervention for Cancer Patients Undergoing Chemotherapy in the Ambulatory Setting
研究概览
详细说明
PRIMARY OBJECTIVES:
I. To explore the feasibility of a proactive nurse-driven telephone triage intervention for patients with cancer receiving first-line chemotherapy in the ambulatory setting.
SECONDARY OBJECTIVES:
I. To explore the symptom experience of patients receiving a nurse-driven telephone triage intervention while receiving chemotherapy in the ambulatory setting.
II. To explore the satisfaction of patients receiving a nurse-driven telephone triage intervention while receiving chemotherapy in the ambulatory setting.
III. To explore the frequency of emergency room visits and hospital admissions for symptom management by patients receiving a nurse-driven telephone triage intervention while receiving chemotherapy in the ambulatory setting.
OUTLINE:
During standard of care chemotherapy, patients receive up to 18 telephone calls from a nurse using a standardized triage call script over 20 minutes.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Texas
-
Houston、Texas、美国、77030
- M D Anderson Cancer Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- English speaking
- Newly diagnosed patients with a breast, sarcoma, or head and neck cancer diagnosis preparing to undergo first-line, standard of care chemotherapy (patients with head and neck cancer may be undergoing concurrent first-line chemotherapy and radiation treatment)
- All chemotherapy treatment to be completed at the study institution
Exclusion Criteria:
- Patients who have received previous chemotherapy treatment for cancer
- Patients who will be receiving chemotherapy on research protocols
- Pregnant patients, as they may be on unique treatment protocols outside standard of care or have symptom needs that are beyond the scope of this intervention
- Patients who are unable to verbalize (e.g. due to tracheostomy)
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Supportive Care (telephone intervention)
During standard of care chemotherapy, patients receive up to 18 telephone calls from a nurse using a standardized triage call script over 20 minutes.
|
辅助研究
接听电话
Complete survey
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Feasibility of completing nurse-driven telephone triage calls
大体时间:Up to 25 weeks
|
Completion is defined as the patient answering the call and completing the assessment; the target completion rate is set as 70%.
Completion of nurse-driven calls will be assessed separately by center (breast, sarcoma, head and neck) and globally across all centers.
The study will declare the intervention to be feasible within a center if the 90% confidence interval for completion rate is completely above 70% or contains 70%.
To calculate the confidence interval, the study will construct a generalized linear mixed model with only a term for intercept.
|
Up to 25 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Symptom experience
大体时间:Up to 25 weeks
|
Will be measured using the MD Anderson Symptom Inventory (MDASI).
This information will be summarized using graphical methods including box-plots and histograms, as well as summary statistics and 90% confidence intervals.
The MDASI will be assessed by center and time point, as well as by time point across all centers.
|
Up to 25 weeks
|
Patient Satisfaction
大体时间:Up to 25 weeks
|
This information will be summarized using graphical methods including box-plots and histograms, as well as summary statistics and 90% confidence intervals.
Satisfaction will be assessed by treatment group and by time point, as appropriate.
They will also be assessed by center and again across all centers.
|
Up to 25 weeks
|
Number of emergency room visits
大体时间:Up to 25 weeks
|
This information will be summarized using graphical methods including box-plots and histograms, as well as summary statistics and 90% confidence intervals.
Number of emergency room visits will be assessed by treatment group and by time point, as appropriate.
They will also be assessed by center and again across all centers.
|
Up to 25 weeks
|
Number of hospital admissions
大体时间:Up to 25 weeks
|
This information will be summarized using graphical methods including box-plots and histograms, as well as summary statistics and 90% confidence intervals.
Number of hospital admissions will be assessed by treatment group and by time point, as appropriate.
They will also be assessed by center and again across all centers.
|
Up to 25 weeks
|
合作者和调查者
调查人员
- 首席研究员:Colleen Jernigan、M.D. Anderson Cancer Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.