Congress Abstracts 2006

227

PARTICIPATING PATIENTS' REACTIONS TO EARLY CLOSURE OF A CLINICAL TRIAL FOR NEGATIVE RESULTS. Jane Bryce, RN, MSN, Marianna Connola, Antonella Salzano de Luna, Corrado Caraco, and Maria Grazia Chiofalo, Istituto Nazionale dei Tumori, Fondazione G. Pascale, Napoli, Italy; Carol Bell, RN, BSN, Stanford University School of Medicine, Palo Alto, CA; and Nicola Mozzillo, MD, Istituto Nazionale dei Tumori, Fondazione G. Pascale, Napoli, Italy.

Clinical trial (CT) literature provides information on early stopping rules and the mechanics of closure of CTs, but little guidance is available to clinicians regarding support of the patient who must abruptly stop trial therapy. An initial step is to understand patients' reactions to early stopping.

The purpose of this study is to explore patients' reactions to the early closure of a negative CT while providing education and support to patients transitioning to a new phase of care.

A cooperative inquiry framework was chosen to gain understanding together with patients and allow the clinical trial nurse (CTN) to provide nursing care through educational and supportive interventions.

The study was conducted with 16 patients enrolled in an international phase III adjuvant therapy trial for stage IV melanoma (CancerVax MMAIT-4-001) when the study was closed early after interim analysis demonstrated unlikelihood of positive results. Patients were notified in person of study closure by Investigator and CTN. The CTN conducted follow up semi-structured interviews with patients 6-10 weeks after closure to determine: patient reaction to trial closure, further treatment sought, positive and negative experiences of participating in the CT, patient informational and emotional needs. A second session was conducted 14-16 weeks after closure to disclose treatment assignments. Interviews were caring interventions providing information, emotional support and insight to help patients' transition to the next phase of treatment. Findings were evaluated for themes by CTNs. All patients continue nursing follow up at regular intervals.

Emerging themes related to closure were: initial fears of abandonment by the health care team and of doing nothing against the disease, both with diminishing impact at second interview. Positive experiences reported were perception of being cared for by the CTN, facilitated access to the health care team, and the treatment cohort as an informal support group. Negative experiences reported were being caught off-guard at study closure and the lack of treatment alternatives. Identified patient needs included reassurance, information on alternate therapies and impact of trial therapy on future options. The ongoing CTN-patient relationship provides a basis for meeting the multiple needs of patients when CTs are stopped early.