Protocol Number: 09-C-0052

Title:

Informed Consent in Pediatric Phase I Cancer Trials

Number:

09-C-0052

Summary:

Background:

-The clinical course and poor prognosis of children and adolescents eligible for pediatric phase I trials may increase the vulnerability of patients and their families and confound informed consent

-Physicians report a tension between presenting reasonable options and a truthful prognosis while maintaining hope.

-Research on the communication and decisions regarding participation in pediatric phase I trials is needed.

Objectives:

-The primary objective of this study is to understand communication, comprehension, and decision-making in Phase I childhood cancer trials (Specific Aim 1) by examining:

---The way that phase I pediatric trials are presented (Aim 1 Hypothesis 1)

---Whether and how alternatives (such as hospice) are introduced (Aim 1 Hypothesis 2)

---What parents and children older than 14 years understand after the consent discussion (Aim 1 Hypothesis 3)

---How the communication process influences parental comprehension and decision-making regarding participation of their child in a phase I study (Aim 1 Hypothesis 4)

---How clinician-investigator perspectives may vary from that of the parent of a child participating in a phase I study (Aim 1 Hypothesis 5)

-Compare Phase I vs. Phase III pediatric cancer informed consent (Specific Aim 2) regarding

---Parental understanding of the scientific goals of the trial (Aim 2 Hypothesis 1)

---Trust, decision making preferences, strength of recommendation by investigators interactivity as measured by number of parental questions, reasons for decisions, child's involvement, reading consent document, parental understanding of choice and trial design/purpose, disclosure of prognosis (Aim 2 Hypothesis 1-9)

---Develop suggestions for interventions to improve informed consent in Phase I pediatric cancer trials through Parent Advisory Group on Informed Consent (PAGIC).(Specific Aim 3)

Eligibility:

-Parents or guardians of children and adolescents considering enrollment on Phase I Trials of anti-cancer agents, gene transfer or vaccine studies are eligible if the child or adolescent is less than 22yrs with diagnosed with a recurrent or refractory malignant solid tumor or leukemia.

-Participants must speak English or Spanish.

-Parents or guardians of children or adolescents who are newly diagnosed with cancer or previously participated in informed consent research are excluded.

-In addition, we plan to interview a smaller number of patients who are 14-21 years of age and who have participated in an informed consent conference for a Phase I cancer trial.

Design:

-Parents (n=132) of children or adolescents (age less than or equal to 21yr) who are being offered participation in a Phase I clinical trial for cancer will be sequentially recruited.

-The methods will include direct observation, digital recording of ICC, and questionnaires of parent/guardian, patients, and health care team members. Research Assistants (RAs) will be trained to observe and record all interactions between families and clinicians that relate to the Phase I clinical trial. Children over 14 years old will be interviewed using a separate instrument

-Data will be analyzed by quantitative and qualitative analytic methods. To assure 120 cases for analysis, the total accrual is 132 cases at six institutions, up to 100 will be accrued at the NCI.

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 participation 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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