Informed Consent in Pediatric Cancer Trials - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00923650

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:

Genetics Home Reference related topics: neuroblastoma

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

National Cancer Institute (NCI)

More Information

Publications:

Sunkel C, Cillero F, Armijo M. [2-(p-Acetamidophenyloxy)ethyl-o-acetoxybenzoate (eterilate). A new anti-inflammatory derived from acetylsalicylic acid. Synthesis and its physico-chemical properties] Arch Farmacol Toxicol. 1978 Apr;4(1):153-5. Spanish. No abstract available.

Lind SE. Can patients be asked to pay for experimental treatment? Clin Res. 1984 Oct;32(4):393-8. No abstract available.

Ting AT, Karnitz LM, Schoon RA, Abraham RT, Leibson PJ. Fc gamma receptor activation induces the tyrosine phosphorylation of both phospholipase C (PLC)-gamma 1 and PLC-gamma 2 in natural killer cells. J Exp Med. 1992 Dec 1;176(6):1751-5.

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 February 09, 2012