Informed Consent in Pediatric Cancer Trials

NCT00923650 | Completed

• 2 other identifiers: 09005209-C-0052
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Osteosarcoma; Ewing's Sarcoma; Neuroblastoma; Brain Tumors; Leukemia

Keywords

Informed Consent; Pediatric Phase I Clinical Trials; Assent; Questionnaires; Osteosarcoma; Ewing's Sarcoma; Neuroblastoma; Brain Tumors; Leukemia

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Cleveland Clinic Foundation Childrens Hospital

Cleveland, Ohio, 44195, United States

Location

Related Publications (3)

• 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. No abstract available. Spanish.

  PMID: 697385 BACKGROUND

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

  PMID: 6509865 BACKGROUND

• 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. doi: 10.1084/jem.176.6.1751.

  PMID: 1281218 BACKGROUND

MeSH Terms

Conditions

Osteosarcoma; Sarcoma, Ewing; Neuroblastoma; Brain Neoplasms; Leukemia

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 17, 2009
• First Posted: June 18, 2009
• Study Start: December 9, 2008
• Study Completion: February 2, 2010
• Last Updated: July 2, 2017

Record last verified: 2010-02-02

Locations

US (2)