An Exploratory Survey of Nurses' Perceptions of Phase I Clinical Trials in Pediatric Oncology

Abstract

This study suggests that nurses' perceptions of pediatric oncology phase I clinical trials are diverse and mixed but are more likely to be positive than negative. Improving future treatments, medical benefit, improved quality of life, and hope were cited as potential benefits of phase I clinical trials, but nurses felt that families were hoping for a cure. Toxicities, false hope, and decreased quality of life were perceived as potential negative outcomes. Acting as a patient advocate was viewed as the most important nursing role, and providing information was identified to be the most important purpose of informed consent. Although not statistically significant, data suggest that age, experience, and practice setting may influence nurses' perceptions. Younger or less experienced nurses were more likely to report either positive or negative perceptions, whereas older or more experienced nurses expressed mixed or moderate perceptions. Inpatient nurses reported more negative perceptions compared with outpatient nurses. The respondents report that caring for patients on phase I had both positive and negative effects on their quality of nursing work life.

Ethical Dilemmas and Ethical Competence in the Daily Work of Research Nurses

“…In such situations, the informants in the present study seemed to adhere to a care-centred ethic, i.e., the role as a nurse seemed to take priority over the task as a research assistant, and they described how they strived to act as the patient's advocate. The fact that nurses involved in clinical studies apprehend acting as a patient advocate as an important nursing task has previously been pointed out by Chang [7].…”

“…Some of these articles focus upon obtaining informed consent and working participant-centred [7,8,13]. Wilkes and Beale [42] found that one ethically troubling situation for research nurses can be the experienced role conflict between being a nurse providing care and being a research assistant.…”

Physician and Nurse Beliefs of Phase 1 Trials in Pediatric Oncology

“…The responsibilities of nurses caring for pediatric oncology patients are diverse, including serving as medical caregiver, advocate, educator, and research assistant 7 . Given the diverse functions of nurses caring for pediatric oncology patients, including the extended periods of intense face-to-face interactions, the impact that nurses have on patient and family decision-making processes is important to consider.…”

Ethical Considerations in Pediatric Oncology Phase I Clinical Trials According to The Belmont Report

“…A risk-benefit assessment must also take into consideration that studies of investigational drugs may be the last remaining treatment option for children with advanced cancer (Chang, 2008). Despite the less than 8% chance of positive response (Shah et al, 1998), patients and families may favorably view the potential for any amount of benefit.…”