Protocol Number: 09-C-0052

Title:

Informed Consent in Pediatric Phase I Cancer Trials

Number:

09-C-0052

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.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility 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

Special Instructions:

Currently Not Provided

Keywords:

Informed Consent

Pediatric Phase I Clinical Trials

Assent

Questionnaires

Recruitment Keyword(s):

Osteosarcoma

Ewing's Sarcoma

Neuroblastoma

Brain Tumors

Leukemia

Condition(s):

Osteosarcoma

Ewing's Sarcoma

Neuroblastoma

Brain Tumors

Leukemia

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

Daugherty CK, Banik DM, Janish L, Ratain MJ. Quantitative analysis of ethical issues in phase I trials: a survey interview of 144 advanced cancer patients. IRB 2000 May-Jun;22(3):6-14.

Oberman M, Frader J. Dying children and medical research: access to clinical trials as benefit and burden. Am J Law Med. 2003;29(2-3):301-17.

Gordon EJ, Daugherty CK. 'Hitting you over the head': oncologists' disclosure of prognosis to advanced cancer patients. Bioethics. 2003 Apr;17(2):142-68.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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