Informed Consent in Pediatric Phase I Cancer Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 2
研究概览
简要总结
Background:
- Informed consent is the process by which prospective participants in clinical trials learn about clinical research in order to decide whether they want to enroll in the study. It consists of meetings and discussions with the health care team.
- Phase I clinical trials are designed to determine what dose of an investigational agent is safe to administer to patients.
Objectives:
- To study communication, comprehension and decision-making during the informed consent process.
- To examine ethical, psychological, social, and educational issues regarding informed consent.
- To help researchers understand how to improve informed consent and education about clinical research.
Eligibility:
- Parents or guardians of children with cancer who are being considered for participation in phase I clinical trials
- Prospective patients for pediatric phase I clinical trials who are between 14 and 21 years of age.
- Members of the research team who obtain consent from patients and families for pediatric phase I clinical trials
Design:
- Research assistants observe and record the informed consent conference held with the research team and the parents and children.
- After the conference, the research assistant interviews the parents in a private area about their experience during the conference and their decision-making process. They are asked about their thoughts and opinions during the informed consent conference, including the decision-making process, communication and trust in the medical team.
- With their parent's permission, patients are interviewed privately to discuss their experience during the informed consent conference.
- After parents and patients have made their decision about participation in the study, they are interviewed again about how they made the decision, aspects of the communication during the conference, and how they feel about the doctor. This interview is also recorded.
- Parents may be contacted 6 months to 2 years from the time of their participation to be part of a parent advisory group about the informed consent process.
详细描述
Background:
- The clinical course and poor prognosis of children and adolescents eligible for pediatric phase I trials may increase the vulnerability of patients and their families and confound informed consent
- Physicians report a tension between presenting reasonable options and a truthful prognosis while maintaining hope.
- Research on the communication and decisions regarding participation in pediatric phase I trial is needed.
Objectives:
-
The primary objective of this study is to understand communication, comprehension, and decision-making in Phase I childhood cancer trials (Specific Aim 1) by examining:
-
The way that phase I pediatric trials are presented (Aim 1 Hypothesis 1)
-
Whether and how alternatives (such as hospice) are introduced (Aim 1 Hypothesis 2)
-
What parents and children older than 14 years understand after the consent discussion (Aim 1 Hypothesis 3)
-
How the communication process influences parental comprehension and decision-making regarding participation of their child in a phase I study (Aim 1 Hypothesis 4)
-
How clinician-investigator perspectives may vary from that of the parent of a child participating in a phase I study (Aim 1 Hypothesis 5)
-
Compare Phase I vs. Phase III pediatric cancer informed consent (Specific Aim 2) regarding:
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供