Stressor Scale for Clinical Research Coordinators: development and psychometric testing.

AIM: This article is a report of the development and psychometric testing of the Stressor Scale for Clinical Research Coordinators. BACKGROUND: Job stress is viewed as a situation where working conditions interact with individual worker characteristics and result in disruption of psychological or physiological homeostasis. Clinical research coordinators, also known as research nurses, are professionals who play a central role in clinical trials. They face various problems associated with their responsibilities; however, few studies have reported on their stress. To manage their stress, it is necessary to identify the sources of stress (i.e. stressors). METHOD: The 56-item preliminary instrument was developed based on literature review and expert discussions. A total of 589 clinical research coordinators in 186 hospitals in Japan were surveyed in 2011. Statistical analyses on construct and concurrent validity, internal consistency, and test-retest reliability were performed. RESULTS: A six-factor solution with 23 items was selected using exploratory factor analysis: 'quantitative workload', 'conflict with investigators', 'ambiguity of work', 'conflict with other clinical research coordinators and with supervisors', 'demands from an affiliate other than the hospital', and 'difficulty in caring for trial participants'. Confirmatory factor analysis affirmed construct validity, with a demonstrated acceptable fit between the factor structure and the observed data. All factors had significant correlations with burnout and psychological distress, which indicated acceptable concurrent validity. Cronbach's alpha coefficients ranged from 0·73-0·82. Intra-class correlation coefficients indicated almost satisfactory test- retest reliability. CONCLUSION: Our new instrument has acceptable validity and reliability for evaluating job stressors for clinical research coordinators.

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.

Gastrointestinal bleeding during anti-angiogenic peptide vaccination in combination with gemcitabine for advanced pancreatic cancer.

Most pancreatic cancer patients are diagnosed at the advanced stages, and no therapy is superior to gemcitabine alone. To confirm the feasibility and efficacy of a novel clinical intervention using tumor vessel-specific anti-angiogenic peptide vaccination, we conducted a clinical phase I/II trial using HLA-A*2402/A*0201-restricted vascular endothelial growth factor receptor type 1 (VEGFR1)-derived peptide vaccination in combination with gemcitabine for advanced pancreatic cancer (http://www.clinical-trials.gov; NCT00683358 and NCT00683085). Four of the enrolled patients (n = 2 for HLA-A*2402 and n = 2 for HLA-A*0201 protocol, respectively), defined as having progressive disease according to the Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v.1.0), failed to respond to the therapy. Another two patients enrolled in HLA-A*2402 protocol dropped out of the study due to rapid disease progression. Grade 2-3 hematologic toxicities were observed in all cases, but the treatment was well tolerated with minimal systemic adverse events. One case in HLA-A*2402 protocol and another case in HLA-A*0201 protocol suffered complicated gastrointestinal (GI) bleeding during vaccination. The causal relationship between GI bleeding and VEGFR1-peptide vaccination is unclear according to the pathologic examination. These studies terminated prematurely because of the advanced stage of the disease in the enrolled patients on entry to the study. Despite GI bleeding, peptide vaccination provides a feasible treatment option for many advanced pancreatic cancer patients.