Congress Abstracts 2004

11

CLINICAL TRIAL NURSING: STRATEGIES FOR DEVELOPING ROLE COMPETENCIES AND ROLE RECOGNITION IN ITALY. Jane Bryce, RN, MSN, OCN^®, Istituto di Tumore, Naples, Italy; Carol Bell, RN, BSN, Istituto Nazionale per la Ricerca Sul Cancro, Genova, Italy; Anna Maria Colussi, RN, Centro Riferimento Oncologico, Aviano, Italy; Gail Di Maio, RN, Istituto Nazionale Tumori, Naples, Italy; and Serenella Gini, RN, Azienda Ospedaliere-Pisa, Pisa, Italy.

The specialized role of the nurse in clinical trials has evolved as the demand for new and more effective cancer therapies has resulted in extensive biomedical research. The complex and diverse responsibilities of the clinical trial nurse (CTN) have been described in the literature.

Educational and competency requirements have not been established in Italy where this role is relatively new. Because the role is not recognized by many institutes, CTNs frequently do not have official positions within the Italian National Health System.

A group of clinical trial nurses from Italian Cancer Institutes collaborated to define the responsibilities of the CTN and develop strategies for the preparation, implementation, and evaluation of CTNs. Through networking, discussion, and review of the literature we identified the following objectives.

• Defining the responsibilities of the CTN
• Developing an educational program for CTNs,
• Obtaining institutional recognition of the CTN role, and
• Establishing a network of Italian oncology CTNs.

CTN responsibilities were categorized as patient education and advocacy, patient care and coordination of care, consultation and staff education, management of patient records and data, and evaluation of clinical trial performance. Competency-based job descriptions were written based on these categories with specific responsibilities detailed across the continuum of clinical trial activity. The job description will be proposed as a model for National Cancer Institutes to recruit and evaluate CTNs, with the additional aim of validating the CTN role within the national health system. A post-graduate CTN course has been developed based on the core curriculum of the EORTC oncology nurse group. Continuing education credits from the Italian Ministry of Health and the European Oncology Nursing Society will be obtained. A CTN special interest group has been formed within the Italian Oncology Nursing Association and is charged with further developing strategies for professional development and national recognition of the CTN role.

Establishing minimal education and competency requirements is critical in providing a basis for undertaking the role of CTN, and is the appropriate means for gaining formal recognition of this role in Italy.