Enhancing informed consent in cancer clinical trials;development and evaluation o

加强癌症临床试验中的知情同意；开发和评估

• 批准号: 7336147
• 负责人: Richard Frederick Brown
• 金额: $ 9.4万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-04 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7336147
• 关键词: Achievement; Adult; Area; Audiotape; Breast; Cancer Patient; Categories; Client satisfaction; Clinical; Clinical Trials; Code; Communication; Comprehensive Cancer Center; Consultations; Data; Data Analyses; Decision Aid; Decision Making; Development; Diagnosis; Effectiveness; Evaluation; Focus Groups; Goals; Health Professional; Informed Consent; Intervention; Literature; Lung; Malignant Neoplasms; Malignant neoplasm of prostate; Measures; Methodology; Methods; Oncologist; Operative Surgical Procedures; Outcome; Patient Participation; Patients; Phase; Physicians; Population; Process; Prostate; Purpose; Randomized Clinical Trials; Rate; Reporting; Research; Sampling; Staging; Testing; Writing; base; cancer therapy; improved; infancy; malignant breast neoplasm; novel; oncology; outcome forecast; patient expectation; preference; satisfaction; skills training

DESCRIPTION (provided by applicant): Doctor patient communication about clinical trials is problematic. Increasing patient participation in consultations is associated with better patient outcomes. One method that has demonstrated significant promise in aiding doctor-patient communication are Question Prompt Lists (QPLs). QPLs consist of a list of sample written questions separated into content categories. These simple patient interventions have not been tested in the oncology clinical trial setting. Questions vary across oncology contexts. The results of studies using context-specific QPLs suggest that they are well received by patients and increase specific types of questions asked. The pilot research proposed in this study will develop and evaluate the acceptability of a QPL specific to oncology clinical trials. The utility of this new QPL will be assessed in the clinical setting using a novel measure, the question match ratio. The specific aims of this exploratory study are to; 1) develop a targeted Question Prompt List for Clinical Trials and evaluate its acceptability to cancer patients and 2) explore the utility of the QPL for Clinical Trials in oncology consultations containing a discussion of a Phase I, II or III clinical trial. In stage 1 of the proposed study, (i) lung, breast and prostate cancer patients and their carers and (ii) health care professionals, will participate in separate focus groups to help develop and explore the acceptability of a QPL for Clinical Trials Question list. A qualitative analysis expert will analyze these data. This analysis will inform a final version of the QPL. Stage 2 of the project involves pilot testing the QPL in a sample of lung, prostate and breast cancer patients to explore the utility of the question list and patient satisfaction with the consultation. Prior to their clinical trial, patients will be asked to use the QPL by circling questions they would like to ask. They will complete pre- consultation information and involvement preference scales and post consultation achievement of involvement preferences and satisfaction with the consultation scale. The consultations will be audiotaped, transcribed and coded and these data analyzed using a new measure, the Question Match Ratio. This ratio will be compared with patient satisfaction and preference data to determine the utility of the QPL. It is anticipated that these data will be used to establish the acceptability and utility of the QPL in oncology clinical trial context and providing an evidence base for a proposed randomized clinical trial of the QPL. Patient-doctor communication is often problematic as patients commonly misunderstand trial information and do not achieve their preferences for decision involvement. By creating a question prompt list specifically for discussions concerning clinical trials, patients will gain a better understanding of the clinical trial process and therefore feel more comfortable with the accrual process. This could improve accrual rates as well as communication between doctors and patients.

描述(申请人提供)：临床试验的医患沟通有问题。更多的患者参与会诊与更好的患者结果相关。一种在帮助医患沟通方面显示出重大前景的方法是问题提示列表(QPL)。QPL由分成内容类别的样本书面问题列表组成。这些简单的患者干预措施尚未在肿瘤学临床试验环境中进行测试。不同的肿瘤学背景下，问题各不相同。使用上下文特定QPL的研究结果表明，它们受到患者的欢迎，并增加了提出的特定类型的问题。这项研究中提出的先导性研究将开发和评估肿瘤临床试验专用QPL的可接受性。这种新的QPL的实用性将在临床环境中使用一种新的测量方法--问题匹配率进行评估。这项探索性研究的具体目的是：1)为临床试验开发一个有针对性的问题提示表，并评估其对癌症患者的可接受性；以及2)探索临床试验QPL在肿瘤学咨询中的效用，其中包括对I、II或III期临床试验的讨论。在拟议研究的第一阶段，(I)肺癌、乳腺癌和前列腺癌患者及其护理人员和(Ii)医疗保健专业人员将参加不同的焦点小组，以帮助开发和探索QPL for临床试验问题清单的可接受性。定性分析专家将对这些数据进行分析。这一分析将为QPL的最终版本提供信息。该项目的第二阶段包括在肺癌、前列腺癌和乳腺癌患者的样本中试行QPL，以探索问题清单的效用和患者对咨询的满意度。在临床试验之前，患者将被要求通过圈出他们想问的问题来使用QPL。他们将完成咨询前信息和参与偏好量表，以及咨询后的参与偏好成就和对咨询量表的满意度。咨询将被录音、转录和编码，这些数据将使用一种新的衡量标准--问题匹配率--进行分析。这一比率将与患者满意度和偏好数据进行比较，以确定QPL的效用。预计这些数据将被用来确定QPL在肿瘤学临床试验中的可接受性和实用性，并为拟议的QPL随机临床试验提供证据基础。患者与医生之间的沟通经常是有问题的，因为患者通常误解试验信息，无法实现他们对决策参与的偏好。通过创建专门用于讨论临床试验的问题提示列表，患者将更好地了解临床试验过程，从而对应计过程感到更舒服。这可以改善应收率以及医生和患者之间的沟通。