Difficulties of nursing staff involved in phase 1 oncology trials in Japan.

BACKGROUND: Nurses, such as clinical research coordinators (CRCs) and nursing staff, are playing a greater role in clinical trials. Prior studies show that CRCs face various challenges, yet information on the problems nursing staff encounter in phase 1 oncology trials is limited. OBJECTIVE: The purpose of the present study was to explore using a qualitative and descriptive approach the difficulties that nursing staff experience in their work with phase 1 oncology trials. METHODS: Twenty-one nurses from 2 hospital wards in Japan with phase 1 oncology trials completed semistructured interviews. The data were analyzed qualitatively and descriptively. RESULTS: The results show that nursing staff were expected to take on broader roles as specialists in clinical trial nursing. These expectations led to 3 categories of difficulties: caring for patients, conducting accurate and reliable clinical trials, and collaborating with the clinical trial team. In some cases, these had a negative effect on nurses' attitudes toward clinical trials. CONCLUSIONS: Nursing staff face unique difficulties, including a lack of clearly defined responsibilities and recognition from the clinical trial team. These differ from difficulties in ordinary oncology nursing and are similar to those encountered by CRCs. IMPLICATIONS FOR PRACTICE: The clinical trial team should reinforce the need for a collaborative approach, provide education and support for nursing staff, and recognize the critical role nurses play as specialists. These steps are important for the well-being of patients and the conduct of high-quality clinical trials.

Decision making for cancer clinical trial participation: a systematic review.

PURPOSE/OBJECTIVES: To describe what is known about the factors that influence cancer clinical trial decision making. DATA SOURCES: PubMed database and reference lists of identified articles. DATA SYNTHESIS: Variations in research design and methods, including sample characteristics, instrumentation, time between decision made and measurement of decision making, and response rates, have effects on what is known about decision making for cancer clinical trial participation. Communication, whether in the form of education about a cancer clinical trial or as a personal invitation to join, is an important factor influencing decision making. Personal and system factors influence the outcomes of decision making for cancer clinical trials. CONCLUSIONS: The process of decision making for cancer clinical trials is understudied. Nevertheless, the currently available cancer clinical trial decision-making literature suggests a multitude of factors that influence the outcomes of the decision to accept or decline clinical trial participation, as well as the psychosocial consequences of decisional regret, pressures, and satisfaction. IMPLICATIONS FOR NURSING: The decision-making process of cancer clinical trials is a fertile area for research and, subsequently, evidence-based interventions. Oncology nurses are in a position to facilitate the process and to relieve the pressures patients perceive regarding decision making for cancer clinical trials that will benefit individuals and, ultimately, society.

Healthy participants in phase I clinical trials: the quality of their decision to take part.

AIMS AND OBJECTIVE: This study was set out to test the quality of the decision-making process of healthy volunteers in clinical trials. BACKGROUND: Researchers fear that the decision to volunteer for clinical trials is taken inadequately and that the signature on the consent forms, meant to affirm that consent was 'informed', is actually insubstantial. DESIGN: The study design was quasi-experimental, using a convenience quota sample. METHODS: Over a period of a year, candidates were approached during their screening process for a proposed clinical trial, after concluding the required 'Informed Consent' procedure. In all, 100 participants in phase I trials filled out questionnaires based ultimately on the Janis and Mann model of vigilant information processing, during their stay in the research centre. RESULTS: Only 35% of the participants reached a 'quality decision'. There is a definite correlation between information processing and quality decision-making. However, many of the healthy research volunteers (58%) do not seek out information nor check alternatives before making a decision. CONCLUSIONS: Full disclosure is essential to a valid informed consent procedure but not sufficient; emphasis must be put on having the information understood and assimilated. Research nurses play a central role in achieving this objective.

Nurses' perceptions of phase I clinical trials in pediatric oncology: a review of the literature.

A review of literature was conducted to explore nurses' perceptions of phase I clinical trials in pediatric oncology. Specifically, nurses' perceptions of the goals and outcomes, the nurse's role, and the informed consent process in pediatric oncology phase I clinical trials were investigated. Findings on possible factors influencing the nurses' perceptions and the quality of work-life of nurses working at pediatric phase I clinical trial centers were also searched. However, despite an extensive review of published works, no studies on nurses' perceptions of phase I trials in pediatric oncology were found. Therefore, this literature review consists of findings in similar or related studies such as nurses' perceptions of experimental therapies in the adult setting, adult patients' perceptions, parents' perceptions, or oncologists'perceptions of phase I clinical trials.

Factors that influence a patient's decision to participate in a phase I cancer clinical trial.

PURPOSE/OBJECTIVES: To explore factors that influence an individual's decision to participate in phase I cancer clinical trials. DESIGN: Exploratory, descriptive, and qualitative study. SETTING: Outpatient oncology clinic of a comprehensive cancer center in an urban setting. SAMPLE: 22 patients with cancer who had been asked at some point during their treatment to participate in a phase I cancer clinical trial were invited to participate in a focus group. Eight patients participated. METHODS: Two focus groups were conducted. MAIN RESEARCH VARIABLES: Factors that influenced patients' decisions to participate in a phase I cancer clinical trial. FINDINGS: Participants expressed that hope for a cure and trusting the oncologist's advice were the primary factors that influenced their decisions to participate in phase I research. The majority expressed surprise that anyone would participate in an experimental study for altruistic reasons. CONCLUSIONS: Patients choose to hope for some personal benefit from their participation in phase I clinical trials even though they realized that is not the purpose or goal of the trial. IMPLICATIONS FOR NURSING PRACTICE: Nurses are in an ideal position to offer information to individuals who are deciding whether to participate in a phase I cancer clinical trial. However, most nurses are not seizing this opportunity. Patients are unable to describe nurses' impact on their decision to enter a phase I cancer clinical trial.