Expectations and experiences of patients with cancer participating in phase I clinical trials.

PURPOSE/
OBJECTIVES: To describe the expectations and experiences of patients entering phase I clinical trials.
DESIGN: Descriptive, exploratory, prospective.
SETTING: A large military medical teaching center. SAMPLE: Thirty-seven adult patients completed the entry and exit interviews. Subjects had a good performance status, were middle aged, and had common tumor types.
METHODS: Interviews using structured entry and exit questionnaires. MAIN RESEARCH VARIABLES: Expectations and experiences of patients in phase I clinical trials.
FINDINGS: Patients expected slightly increased support from family members and received more support than expected. Patients' expectations for tumor response and increased communication with their physician were not met. Patients expected symptoms such as fatigue, nausea and vomiting, and weight loss to improve during therapy, yet their expectations were not met.
CONCLUSIONS: One theme that emerged from the data was hope/optimism. An issue that needs further exploration is the extent to which patients accurately understand information in the consent form. Findings also support the importance of communication between the patient and family members and the healthcare team. IMPLICATIONS FOR NURSING PRACTICE: Oncology nurses can mediate the flow of information between physicians and patients. Oncology nurses can and should assess the patient's level of understanding of the clinical trial, the consent form, and potential side effects at the time of entry into the trial and intermittently during the course of therapy. Nurses must allow patients with cancer who are undergoing investigational therapy to maintain a level of hope, while realistically counseling them about their progress during phase I trial participation.