Leukemia Clinical Trial
Official title:
Informed Consent in Pediatric Phase I Cancer Trials
Verified date | February 2, 2010 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1 |
Est. completion date | February 2, 2010 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 21 Years |
Eligibility |
- 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 |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
United States | Cleveland Clinic Foundation Childrens Hospital | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Lind SE. Can patients be asked to pay for experimental treatment? Clin Res. 1984 Oct;32(4):393-8. — View Citation
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. — View Citation
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. — View Citation
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