Informed Consent in Pediatric Cancer Trials
This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00923650
First received: June 17, 2009
Last updated: February 3, 2010
Last verified: February 2010
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Purpose
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.
| Condition |
|---|
|
Osteosarcoma Ewing's Sarcoma Neuroblastoma Brain Tumors Leukemia |
| Study Type: | Observational |
| 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
U.S. FDA Resources
Further study details as provided by National Institutes of Health Clinical Center (CC):
| Enrollment: | 1 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | February 2010 |
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
- INCLUSION CRITERIA:
Parent/Guardian:
- Patient must be less than or equal to 21 years of age at the time of consent.
- Parent/guardian must be considering having their child participate in a Phase I treatment trial
- Parents must be able to speak English or Spanish
- Must sign informed consent for participation in this study
Patients greater than or equal to14 years of age and less than or equal to 18 years of age:
- Must be considering participating in a Phase I treatment trial
- Must be able to speak English or Spanish
- Must assent for participation in this study
Patients greater than or equal to 18 years old:
- Must be considering participating in a Phase I treatment trial
- Must be able to speak English or Spanish
- Must sign informed consent for participation in this study, which will include consent to interview parent/guardian, if available
Heath Care Team Members:
- Must be greater than or equal to 18 years of age
- Must speak English or Spanish
- Must sign an informed consent document for participation in this study (written consent will be obtained annually for heath care team members)
- Verbal assent to participate in each individual consent conference
EXCLUSION CRITERIA:
- Patients who are newly diagnosed who are being offered participation in a Phase I trial because no standard therapy exists for their disease
- Patients/Parents who have previously participated in informed consent research conducted by Cleveland Clinic Foundation Department of Bioethics
- Families who do not speak English or Spanish
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00923650
Locations
| 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
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00923650 History of Changes |
| Obsolete Identifiers: | NCT00891410 |
| Other Study ID Numbers: | 090052, 09-C-0052 |
| Study First Received: | June 17, 2009 |
| Last Updated: | February 3, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Informed Consent Pediatric Phase I Clinical Trials Assent Questionnaires Osteosarcoma |
Ewing's Sarcoma Neuroblastoma Brain Tumors Leukemia |
Additional relevant MeSH terms:
|
Brain Neoplasms Leukemia Neuroblastoma Osteosarcoma Sarcoma, Ewing's Neuroectodermal Tumors, Primitive, Peripheral Sarcoma Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Neoplasms by Histologic Type Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue |
ClinicalTrials.gov processed this record on June 17, 2013