Communicating and understanding the purpose of pediatric phase I cancer trials.

Purpose: Quality informed consent should provide a clear understanding of the purpose of the research. Given the ethical challenges of pediatric phase I cancer trials, it is important to investigate physician-parent communication during informed consent conferences (ICCs) and parental understanding of the purpose of these studies.

Methods: In the multisite Informed Consent in Pediatric Phase I Cancer Trials study, 85 ICCs for phase I research between June 2008 and May 2011 were directly observed, and 60 parents were subsequently interviewed.

Adolescent perspectives on phase I cancer research.

Background: The aim of this study was to examine adolescent patients' perspectives on their understanding and decision making about a pediatric phase I cancer study.

Procedure: Participants included adolescents ages 14-21 years with cancer (N = 20), all of whom attended a phase I study consent conference. Participants responded to closed- and open-ended questions on a verbally administered structured interview, which assessed aspects of understanding and decision making about the phase I study.

Negotiating decisions during informed consent for pediatric Phase I oncology trials.

During informed consent conferences (ICCs) for Phase I trials, oncologists must present complex information while addressing concerns. Research on communication that evolves during ICCs remains largely unexplored. We examined communication during ICCs for pediatric Phase I cancer trials using a stratified random sample from six pediatric cancer centers.

Informed consent for pediatric phase 1 cancer trials: physicians' perspectives.

Background: This study was conducted to gather pediatric oncologists' opinions about and suggestions for improvement of informed consent (IC) in pediatric phase 1 cancer trials.

Methods: A questionnaire designed to elicit perspectives was distributed to 146 physicians at 6 participating institutions. A total of 103 completed surveys were returned for a 71% response rate.

Anticipatory guidance to improve informed consent: a new application of the concept.

Although the concept of anticipatory guidance has long been used in general pediatrics to help prepare parents for what to expect in the coming months or year, this educational concept has not been transplanted for use in other contexts. The intervention described in this article uses the principles of anticipatory guidance in an effort to prepare parents of children with newly diagnosed acute leukemia for their upcoming discussions with their child's physician. Parents of children recently diagnosed with leukemia frequently feel overwhelmed and are anxious to discover what can be done to cure their child.

Improving informed consent: suggestions from parents of children with leukemia.

Objective: The objective of this study was to report suggestions for improving the informed consent process from the perspective of parents of children with leukemia.

Methods: Recommendations for improving informed consent were elicited from 140 parents of children who had been offered participation in a randomized clinical trial for the treatment of their acute leukemia. Four different methods and data collection time points were used with this group of parents, including open-ended, in-person interviews within 72 hours after the informed consent conference; follow-up telephone interviews 6 months after diagnosis; focus groups during year 3 of the project; and a parent advisory group on informed consent meeting in year 4.