title: The Breast Cancer Prevention Trial: nurses' observations.
abstract: The Breast Cancer Prevention Trial (BCPT), a case study of a clinical prevention trial, offered a unique opportunity to examine the multifaceted and complex role of the nurse. The primary aims of this study were (a) to identify the self-descriptions of a sample of nurses involved in the day-to-day management of the BCPT, (b) to determine the nurses' perceptions of their own role and the role of the women who joined the BCPT, (c) to understand the role of the nurse in the larger context of a clinical prevention trial, and (d) to expand the knowledge base regarding some of the social and ethical underpinnings of clinical prevention trials with healthy participants. The research design was qualitative, descriptive, and exploratory. The methods used were the telephone interview and the focus group. Fifty BCPT nurses were interviewed. This included 30 telephone interviews and 20 additional BCPT nurses who participated in four national and international focus groups. After analysis of the data using ethnographic methods, a view of the multi-faceted role of the BCPT nurse emerged. On a broader scale, the inquiry raised a number of critical ethical and social issues that are relevant to future clinical prevention trials with volunteer human participants.
authors.affiliation: University of Pennsylvania, Philadelphia 19104-6096, USA.
authors.forename: T G
authors.initials: TG
authors.lastname: Freedman
mesh_terms: D001943:Breast Neoplasms / Q000451:nursing / Q000517:prevention & control*; D002170:Canada; D015400:Clinical Nursing Research / Q000379:methods; D016265:Conflict of Interest; D003625:Data Collection / Q000379:methods; D004311:Double-Blind Method; D005260:Female; D017144:Focus Groups; D006801:Humans; D007258:Informed Consent; D033281:Nontherapeutic Human Experimentation; D018579:Patient Selection; D014481:United States