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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. RESULTS: All participants decided to enroll in the phase I study. The majority of participants understood that participation was voluntary, entailed risks, and that they could withdraw. Most also believed that participation in the phase I study would increase the length of their lives. The most frequent reasons for enrolling were positive clinical benefit, needing an option, impact on quality of life, and few side effects or fewer than those of current or past treatments. Eighty-five percent of participants reported that they themselves made the final decision about enrollment in the phase I study. CONCLUSIONS: Most participants hoped or expected that the phase I study would provide a direct benefit (increased survival time or cure) and reported that they themselves were the final decision-maker about enrollment. Clinicians may underestimate the role of adolescents, especially if they believe that parents typically make such decisions. Future research should assess the actual participation of children and adolescents during the informed consent process and explore the role of hope in their decision making about phase I studies.

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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. The scientific purpose was defined as composite understanding of drug safety, dose finding, and dose escalation. We determined the frequency with which physicians explained these and other phase I-related concepts during the ICC. Parent interviews were analyzed to determine understanding. RESULTS: The child was present at 83 of 85 ICCs. Only 32% of parents demonstrated substantial understanding of the scientific purpose of phase I cancer trials; 35% demonstrated little or no understanding. Parents of higher socioeconomic status and racial majority status were more likely to understand the scientific purpose. Factors associated with understanding included physician explanation of the goal of the applicable phase I protocol offered (explained in 85% of ICCs) and explanation of the dose cohorts (explained in 43% of ICCs). Physicians explained drug safety in 23% of ICCs, dose finding in 52% of ICCs, and dose escalation in 53% of ICCs. CONCLUSION: Many parents of children participating in phase I trials do not understand the purpose of these trials. Physician-parent communication about the purpose of phase I research is lacking during ICCs.

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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. A grounded theory approach identified key communication steps and factors influencing the negotiation of decisions for trial participation. Analysis suggests that during ICCs, families, patients, and clinicians exercise choice and control by negotiating micro-decisions in two broad domains: drug logic and logistics, and administration/scheduling. Micro-decisions unfold in a four-step communication process: (1) introduction of an issue; (2) response; (3) negotiation of the issue; and (4) resolution and decision. Negotiation over smaller micro-decisions is prominent in ICCs and merits further study.

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OBJECTIVE: In this study we evaluated the effectiveness of a physician-directed intervention at enhancing positive physician behaviors and communication strategies during informed consent conferences (ICCs) for pediatric acute leukemia clinical trials. PATIENTS AND METHODS: Physicians at 2 large pediatric hospitals were recruited to participate in a physician-directed intervention (PDI), which included 1 full-day seminar and successive half-day booster sessions. ICCs were then observed, audiotaped, coded, and analyzed to evaluate the effectiveness of the intervention. Data also were collected at 2 control sites. Between 2003 and 2007, 59 ICCs were observed and analyzed. RESULTS: Significant group differences were found in physician rapport-building behaviors. Physicians in the PDI + booster session group engaged in greater rapport-building than did physicians in the PDI group who did not attend booster sessions and physicians in the control group. No group differences were detected for physician partnership-building. In addition, parents in the PDI + booster session group engaged in more general communication and study-related communication, and mothers in the PDI groups asked significantly more questions per minute than did mothers in the control group. CONCLUSIONS: These results provide support for the effectiveness of the PDI at enhancing positive physician behaviors. Booster-session attendance is a critical component of physician-directed interventions to improve parental participation and physician-parent communication during ICCs.

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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. RESULTS: Pediatric oncologists believe providing information so families can decide about phase 1 study entry is the most important goal of the IC process (ICP). The majority of physicians (64%) report that they describe the phase 1 study without any attempt to influence parents' decisions. Several answers provided by physicians were associated with their gender and prior IC training. Male physicians were significantly more likely to endorse the no-attempt-to-influence approach, whereas female physicians were more likely to suggest to parents that other children will benefit from what is learned in phase 1 studies. Responses to an open-ended question provided 63 suggestions for improvement of the ICP, including document and training changes and tools to enhance physician-family communication. CONCLUSIONS: Pediatric oncologists tended to present phase 1 trials as an option rather than a strong recommendation and were reluctant to influence decisions of families about these studies. They believe most but not all parents understand key concepts involved in consent to this type of research, and had ample suggestions for how to improve the ICP. Future research and education efforts around this ethically challenging topic were warranted.

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PURPOSE: To improve physician communication with parents using a physician-directed intervention (PDI), emphasizing a sequenced approach to the informed consent conference (ICC) for childhood leukemia clinical trials in which physicians discuss diagnosis, prognosis, and treatment prior to the offer of a clinical trial. METHOD: Physicians and fellows at the Children's Hospital of Philadelphia and Children's National Medical Center were recruited to participate in Informed Consent Seminars and subsequent half-day booster sessions. Training was followed by a multisite study of informed consent communication. Real-life ICCs were observed and audiotaped, and parents were interviewed after the ICC to ascertain their understanding. Data from the ICC and interview were then coded and analyzed. Trained physician performances were compared with untrained physicians (controls) at two other research sites. Data were collected from 2003 to 2007 at PDI sites and control sites for comparison. RESULTS: A total of 102 cases were included for initial analyses, with 60 cases from the PDI sites and 42 control cases. Fifty-nine cases were included in the final analysis. Findings revealed that trained physicians followed the sequenced approach more often when compared with controls. Similarly, physicians at the PDI sites tended to elicit parental questions and understanding in an open-ended way and clarify parents' questions more frequently than physicians at the control sites. CONCLUSIONS: Academic physicians who are involved in the current transformation of clinical research should be trained to conduct effective ICCs. The "see one, do one, teach one" approach is no longer adequate for informed consent.

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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. By using the abilities of already medically trained oncology nurses and orienting them to conduct an intervention to educate, (empathize) emphasize, and prepare parents for the informed consent conference, this anticipatory guidance-based intervention was designed to target barriers to effective communication and increase the interactivity between families and health care providers.

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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. RESULTS: The most frequently cited suggestions for improving informed consent during the interviews and focus groups related to giving parents more time to make their decision, the amount and type of information provided, organization of the consent conference, communication style, and providing additional materials. During the parent advisory group on informed consent meeting, parents developed specific guidelines for organization of the information that is presented during the consent process that include 7 major components: timing, sequence, checklist, checking for understanding, anticipatory guidance, segue into randomized clinical trial discussion with historical perspective, and choice. CONCLUSIONS: Through the incorporation of parental perspectives that provide an authentic stakeholder voice, our research represents a true partnership approach to improving the consent process. Parents provided practical advice for improving informed consent that can be applied to most adult and pediatric patient populations.

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