Adolescent perspectives on phase I cancer research

Abstract

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.

Patient Involvement in Informed Consent for Pediatric Phase I Cancer Research

“…In addition, physicians and parents may fail to engage children and adolescents in the discussion or actively interfere with their involvement (e.g., interrupting or answering a question that was directed to the child) 24 . The physician’s expectation that the parent will make the final decision is likely to limit attempts to engage the patient in trial or treatment discussions 25, 26 . Family patterns of coping and decision making may also shape patient involvement.…”

“…It also consisted of participants who agreed to participate in a study about informed consent. As such, the participants in our sample might have been less distressed or struggled less with the decision than other patients and families who were offered phase I trial participation 25 . Fourth, the sample size was small for analyses that involved parent or patient interview data, and patient interview data were only available for 14- to 21- year-olds.…”

Children as decision-makers in health care - An integrative review

“…The research results show that a child's knowledge capabilities, wishes and values are often not taken into account and their participation is prevented. [22][23][24][25][26][27][28][29][30] Healthcare professionals make the decisions on behalf of the children and often on behalf of parents as well. [24,25,27,31] The reasons behind this were the attitudes of the personnel and the parents [26,32,33] and the desire to protect the child.…”

Adolescents' preferences for treatment decisional involvement during their cancer

“…[1][2][3] Prior investigations of adolescent oncology patients have revealed that this population can capably engage in complex decisional processes from the time of diagnosis and treatment 4 through decisions such as fertility preservation, 5 research participation, 6 advanced care planning, 7 and end-of-life decisions. 8 Parents and providers report satisfaction when adolescent oncology patients are able to convey preferences and participate in decision-making discussions.…”