Sarcoma Treatment Guide in Improving Self-Monitoring in Patients With Sarcoma Receiving Chemotherapy
2022年9月26日 更新者：James Chen、Ohio State University Comprehensive Cancer Center
Sarcoma Treatment Guide Pilot Study
This randomized pilot clinical trial studies how well the Sarcoma Treatment Guide works in improving self-monitoring in patients with sarcoma who are receiving chemotherapy.
The Sarcoma Treatment Guide may help patients with sarcoma to be better informed, become more engaged with care, encourage communication, and to better manage side effects associated with chemotherapy treatments in order to improve quality of life.
研究概览
详细说明
PRIMARY OBJECTIVES:
I. To evaluate whether symptom management and communication are improved in patients who are chemotherapy naive who receive a Sarcoma Treatment Guide as compared to those that have not.
SECONDARY OBJECTIVES:
I. To explore whether patients who have previously undergone chemotherapy benefit from a Sarcoma Treatment Guide (STG) in regard to symptom management and have improved communication between patient and providers.
II. To assess patient satisfaction with using the STG at the end of the trial.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive the STG before completing 4 courses of standard of care chemotherapy.
ARM B: Patients complete 2 courses of standard of care chemotherapy and then receive the STG before completing 2 additional courses of standard of care chemotherapy.
研究类型
介入性
注册 (实际的)
64
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Ohio
-
Columbus、Ohio、美国、43210
- Ohio State University Comprehensive Cancer Center
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Be able to read, write, and understand English
- Sarcoma clinic patient
- About to begin either oral or cytotoxic chemotherapy
Exclusion Criteria:
- Received previous chemotherapy
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：交叉作业
- 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：Arm A (STG pre-chemotherapy)
Patients receive the STG before completing 4 courses of standard of care chemotherapy.
|
辅助研究
其他名称：
辅助研究
Receive STG
其他名称：
|
|
实验性的：Arm B (STG post-chemotherapy initiation)
Patients complete 2 courses of standard of care chemotherapy and then receive the STG before completing 2 additional courses of standard of care chemotherapy.
|
辅助研究
其他名称：
辅助研究
Receive STG
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 |
|---|---|---|
|
Symptom management and communication improvement in chemotherapy naive patients as measured by participant survey and tracking telephone calls
大体时间：Up to 1 year
|
Will keep notes of qualitative feedback provided by participants regarding the Sarcoma Treatment Guide (STG) obtained from the survey.
Notes will be reviewed to identify common themes that will be considered when making revisions to the STG to be used by chemotherapy patients in the Sarcoma Clinic.
Telephone calls will be calculated for each participant associated with symptoms such as nausea, vomiting, diarrhea, constipation, and pain.
The calls will be logged to track quantity, reason and outcome of all participants.
Symptoms ratings self-reported by patients will be tracked using the Numeri
|
Up to 1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient satisfaction with Sarcoma Treatment Guide (STG) as measured by participant survey and tracking telephone calls
大体时间：Up to 1 year
|
Will keep notes of qualitative feedback provided by participants regarding the STG obtained from the survey.
Notes will be reviewed to identify common themes that will be considered when making revisions to the STG to be used by chemotherapy patients in the Sarcoma Clinic.
Telephone calls will be calculated for each participant associated with symptoms such as nausea, vomiting, diarrhea, constipation, and pain.
The calls will be logged to track quantity, reason and outcome of all participants.
Symptoms ratings self-reported by patients will be tracked using the NRS.
Secondary analysis will inc
|
Up to 1 year
|
|
Sarcoma Treatment Guide (STG) benefit in patients who have undergone chemotherapy as measured by participant survey and tracking telephone calls
大体时间：Up to 1 year
|
Will keep notes of qualitative feedback provided by participants regarding the STG obtained from the survey.
Notes will be reviewed to identify common themes that will be considered when making revisions to the STG to be used by chemotherapy patients in the Sarcoma Clinic.
Telephone calls will be calculated for each participant associated with symptoms such as nausea, vomiting, diarrhea, constipation, and pain.
The calls will be logged to track quantity, reason and outcome of all participants.
Symptoms ratings self-reported by patients will be tracked using the NRS (Numeric Ratings Scale).
Secondary analysis will inc
|
Up to 1 year
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：James Chen, MD、Ohio State University Comprehensive Cancer Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年5月16日
初级完成 (实际的)
2019年6月5日
研究完成 (实际的)
2020年12月15日
研究注册日期
首次提交
2017年8月17日
首先提交符合 QC 标准的
2017年8月22日
首次发布 (实际的)
2017年8月23日
研究记录更新
最后更新发布 (实际的)
2022年9月28日
上次提交的符合 QC 标准的更新
2022年9月26日
最后验证
2022年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- OSU-16301
- NCI-2017-01277 (注册表标识符：CTRP (Clinical Trial Reporting Program))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.