Ferrell Betty R, Borneman Tami, Zachariah Finly, Sun Virginia, Co Nathaniel, Chung Vincent
From City of Hope Medical Center, Duarte, California.
J Adv Pract Oncol. 2025 May 3:1-12. doi: 10.6004/jadpro.2025.16.7.12.
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.
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.
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.
Patients ( = 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.
APRNs can develop a model of care to support patients completing clinical trials.
参与临床试验的患者面临诸多生活质量（QOL）问题，包括与疾病进展相关的问题。本试点项目测试了由高级执业注册护士（APRN）主导的干预措施针对完成I期试验后处于过渡期的胃肠道（GI）肿瘤患者的可行性和初步结果。
目标是（1）根据先前的研究制定“过渡期”护理计划干预措施，以支持患者的生活质量，包括症状管理、心理社会和精神支持以及试验完成后的护理；（2）在胃肠道肿瘤患者样本中测试该干预措施的可行性；（3）评估“过渡期”护理计划干预措施对改善护理和生活质量的影响。
在美国西部一家由美国国立癌症研究所指定的综合癌症中心，收集了完成I期临床试验的胃肠道肿瘤患者的单组便利样本。患者在基线、3个月和6个月时完成问卷调查。在3个月时进行访谈以进一步了解患者需求。APRN与患者和医学肿瘤学家合作，为患者制定了一份“过渡期”护理计划。进行病历审核以记录支持性服务的转诊和完成情况。关键变量包括生活质量领域、痛苦程度以及支持性护理服务的使用情况。
患者（n = 37）在所有生活质量领域都有显著的支持需求。“过渡期”护理计划模型在评估生活质量需求、促进患者对疾病状况的理解以及提供获得支持性护理服务的途径方面很有价值。
APRN可以制定一种护理模式来支持完成临床试验的患者。
