Stakeholder Perspectives on Family Caregiver Involvement in Oncology Clinical Trial Decision-Making

利益相关者对家庭护理人员参与肿瘤临床试验决策的看法

基本信息

批准号：
10591721
负责人：
Susan Mazanec
金额：
$ 16.1万
依托单位：
CASE WESTERN RESERVE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-07-01 至 2023-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10591721
关键词：
Affect Aftercare American Society of Clinical Oncology Asian Attitude Belief Bioethics Cancer Patient Caregiver Burden Caregiver research Caregivers Caring Clinical Trials Communication Communities Complex Data Decision Making Development Elderly Enrollment Excision Face Family Family Caregiver Focus Groups Future Head and Neck Cancer Hispanic Individual Influentials Informed Consent Interview Knowledge Larynx Life Location Malignant Neoplasms Malignant neoplasm of lung Medical Methodology Modeling National Cancer Institute Oncologist Operative Surgical Procedures Participant Patients Personal Satisfaction Play Policies Process Research Role Societies Structure Tongue Tracheostomy procedure Training Visit black patient cancer clinical trial cancer diagnosis cancer therapy clinical trial enrollment ethnic minority evidence base experience novel therapeutics oncology trial parent grant racial minority stakeholder perspectives tumor

项目摘要

Project Summary/Abstract Current informed consent practices for oncology clinical trials focus on individual autonomy and fail to account for the complex obligations and relationships that influence decision-making. Family caregivers are influential in medical decision-making for cancer patients, yet little is known regarding how they are included in clinical trial discussions and what is important to them when considering participation. Clinical trial staff are primarily responsible for informed consent in oncology trials and maintain ongoing contact with patients and caregivers, yet they are also overlooked in clinical trial decision-making research. This study aims to fill this knowledge gap using qualitative methodology to elicit perspectives from family caregivers and clinical trial staff, key stakeholders in oncology clinical trial decision-making. The specific aims are: (1) to understand how family caregivers of patients with cancer conceptualize their role in clinical trial decision making, (2) to determine factors influential to family caregivers of patients with cancer during the clinical trial decision-making process, and (3) to identify attitudes, beliefs, and approaches used by clinical trial staff to navigate family caregiver involvement in the informed consent process for clinical trials. Two focus groups will be conducted, one with oncology clinical trial staff and one with family caregivers of patients with cancer. Thematic analysis of focus group data will refine interview guides for subsequent semi-structured interviews with family caregivers. Results will inform future bioethics research, policies, and practice regarding inclusion of family caregivers in clinical trial informed consent processes.

项目概要/摘要目前肿瘤学临床试验的知情同意实践侧重于个人自主权，未能考虑到影响决策的复杂义务和关系。家庭照顾者有影响力癌症患者的医疗决策中，但人们对如何将其纳入临床决策知之甚少试验讨论以及在考虑参与时对他们来说重要的是什么。临床试验人员主要是负责肿瘤学试验的知情同意并与患者和护理人员保持持续联系，然而，它们在临床试验决策研究中也被忽视。本研究旨在填补这一知识空白使用定性方法来征求家庭护理人员和临床试验人员的观点，关键肿瘤学临床试验决策的利益相关者。具体目标是：（1）了解家庭如何癌症患者的护理人员概念化他们在临床试验决策中的作用，(2) 确定在临床试验决策过程中影响癌症患者家庭护理人员的因素， (3) 确定临床试验工作人员指导家庭护理人员的态度、信念和方法参与临床试验的知情同意过程。将进行两个焦点小组，其中一个肿瘤临床试验人员和一名癌症患者的家庭护理人员。焦点专题分析团体数据将完善后续与家庭护理人员进行半结构化访谈的访谈指南。结果将为未来有关将家庭照顾者纳入其中的生物伦理学研究、政策和实践提供信息。临床试验知情同意流程。