Feasibility Testing of an APRN-Led Model of Care for Transition of Patients After Completion of Phase I Trials.

Background: Patients on clinical trials experience numerous quality of life (QOL) concerns, including those associated with advancing disease. This pilot project tested the feasibility and initial outcomes of an advanced practice registered nurse (APRN)-led intervention for patients with gastrointestinal (GI) tumors transitioning after completing a phase I trial.

Objectives: The objectives were to (1) Develop the "Transitions" care plan intervention based on prior research to support patient QOL including symptom management, psychosocial and spiritual support, and care after trial completion; (2) Test the feasibility of the intervention in a sample of patients with GI tumors; and (3) Evaluate the impact of the Transitions care plan intervention on improved care and QOL.

Methods: A single-group, convenience sample of patients with GI tumors completing phase I clinical trials was accrued at a National Cancer Institute-designated Comprehensive Cancer Center in the western US. Patients completed questionnaires at baseline, 3 months, and 6 months. Interviews were conducted at 3 months for further understanding of patient needs. A Transitions care plan for the patient was developed by the APRN in collaboration with the patient and medical oncologist. Chart audits were conducted to capture supportive services referrals and completions. Key variables included domains of QOL, distress, and use of supportive care services.

Results: Patients (N = 37) had significant needs for support across all QOL domains. The Transitions care plan model was valuable in assessing QOL needs, facilitating patients' understanding of disease status, and providing access to supportive care services.

Implications: APRNs can develop a model of care to support patients completing clinical trials.