Informed Consent in Pediatric Cancer Trials
This study has been completed.
Information provided by:
National Institutes of Health Clinical Center (CC)
First received: June 17, 2009
Last updated: February 3, 2010
Last verified: February 2010
Show Detailed Description
- 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.
- 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.
- 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
- 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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Informed Consent in Pediatric Phase I Cancer Trials|
Resource links provided by NLM:
MedlinePlus related topics: Brain Cancer Cancer Childhood Brain Tumors Leukemia Neuroblastoma Soft Tissue Sarcoma
Genetic and Rare Diseases Information Center resources: Malignant Mesenchymal Tumor Soft Tissue Sarcoma Neuroblastoma Osteosarcoma Bone Cancer Ewing's Sarcoma Ewing's Family of Tumors NeuroepitheliomaU.S. FDA Resources
Further study details as provided by National Institutes of Health Clinical Center (CC):
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||February 2010|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00923650
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|United States, Ohio|
|Cleveland Clinic Foundation Childrens Hospital|
|Cleveland, Ohio, United States, 44195|
Sponsors and Collaborators