Seeking Informed Consent to Phase I Cancer Clinical Trials: Identifying Oncologists'Communication Styles
Seeking Informed Consent to Phase I Cancer Clinical Trials: Identifying Oncologists' Communication Styles
研究概览
详细说明
Subjects will be cancer patients attending one of three outpatient clinics at Memorial Sloan-Kettering Cancer Center. Subjects will be recruited from the Melanoma/Sarcoma, GI and Genitourinary Oncology services. The patients of six oncologists across the three services will be approached. All patients of these six oncologists who are invited to participate in a Phase I clinical trial will be approached to participate in the study. Patients who consent to participate in this study will be included in the sample regardless of their trial decision.
Design and Analysis:
To gather information about the communication strategies used by oncologists to discuss trials, a qualitative analysis of audio recordings of consultations containing discussions of Phase I trials will be conducted. These consultations will be audio recorded and transcribed in full; analysis will proceed using the constant comparative method. Initially (and as is consistent with the qualitative method employed for this study), a small sample of 15 patients will be recruited. Once an exhaustive analysis of this original data set is complete a further set of 15 patients will be recruited and transcripts of these consultations analyzed. In order to identify any new themes, the themes that emerged from the new data set will be compared with those identified in the original data set. We anticipate that the study will be completed within one year of commencement.
Significance: Oncologists report that one of their most significant communication challenges is communicating effectively and ethically with their patients about joining a clinical trial. Communication skills training has demonstrated efficacy in assisting doctors in this difficult task, however, there is a paucity of research in this area and studies have been limited to the Phase II and III trial setting. There is some research evidence that suggests that different communication issues and challenges emerge in the Phase I versus the Phase II and III trial setting. The pilot research proposed in this protocol will: a) explore the types of communication currently used by oncologists when recruiting patients to clinical trials and b) develop a set of communication strategies that can be used to address gaps in doctor- patient communication in this difficult area.
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
New York
-
New York、New York、美国、10065
- Memorial Sloan-Kettering 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
取样方法
研究人群
描述
Inclusion Criteria:
- Patients at the outpatient oncology clinics of the six participating physicians (Drs Schwartz, Scher, Slovin, Tse, Shah & Carvajal)
- Diagnosed with cancer
- Eligible for a Phase I trial
- Discussing participation in such a trial with their physician during their visit
Exclusion Criteria:
- Fewer than 18 years of age
- Not proficient in English
- Cognitively or physically impaired, rendering them incapable of providing informed consent to participate in the study
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
---|---|
1
Participants with certain types of cancers that are eligible for studies at Memorial Sloan-Kettering Cancer Center.
|
Your appointment with your doctor will be audio taped.
The research team will listen to the tape(s) and type them up.
The team will then look for patterns in the discussions between patients and doctors.
They will use this information to see if the discussions can be improved.
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
This study aims to use qualitative research methods to examine the pattern of communication strategies oncologists use to discuss Phase I clinical trials ith their patients.
大体时间:This study will begin with your appointment with your doctor the day of registration and will end at the end of the visit that day.
|
This study will begin with your appointment with your doctor the day of registration and will end at the end of the visit that day.
|
合作者和调查者
调查人员
- 首席研究员:Richard Brown, PhD、Memorial Sloan Kettering 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
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 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 07-096
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.
Consult visit的临床试验
-
Geisinger ClinicPatient-Centered Outcomes Research Institute; Penn State University; University of Nebraska; Iowa...主动,不招人
-
University of Massachusetts, WorcesterNational Institute on Minority Health and Health Disparities (NIMHD)主动,不招人
-
Sarah CockayneUniversity of Nottingham; James Cook University, Queensland, Australia; Queensland Health; Humberside... 和其他合作者终止
-
University of UtahUniversity of Chicago; University of Michigan完全的