Rezash Victoria, Reed Janice, Gedeon Barbara, Parsons Eric, Siedlecki Sandra, Daniels Bradley, Shepard Dale R
Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH, USA.
Office of Nursing Research and Innovation, Cleveland Clinic, Cleveland, OH, USA.
J Patient Exp. 2020 Feb;7(1):27-33. doi: 10.1177/2374373519830743. Epub 2019 Feb 19.
The study design and nature of oncology phase 1 clinical trials create a uniquely vulnerable patient population yet little research has been conducted to identify the added burden these trials create for both cancer patients and their caregiver(s).
Examining the perceptions and needs of patients and their caregivers participating in phase 1 oncology clinical trials, the investigators tested the hypothesis that the caregiver will exhibit a higher level of burden and/or distress than the patient.
A mixed-methods exploratory process utilizing patient and caregiver interviews and quality-of-life questionnaires was used to assess the psychosocial burdens associated with oncology clinical trial participation. A qualitative and quantitative analysis of the responses were 8 performed.
Both patients and caregivers reported similar themes identifying the burdens and benefits related to phase 1 clinical trial participation. However, the caregivers' expressed burden exceeded that of the patients' validating the study's hypothesis.
The need for ongoing additional support services for not only the patient but also the caregiver was identified.
肿瘤学1期临床试验的研究设计和性质造就了一个特别脆弱的患者群体，但针对确定这些试验给癌症患者及其照顾者带来的额外负担，所开展的研究很少。
为检验照顾者负担和/或痛苦程度高于患者这一假设，研究者对参与1期肿瘤学临床试验的患者及其照顾者的认知和需求进行了调查。
采用混合方法探索性流程，通过患者和照顾者访谈以及生活质量问卷，评估与参与肿瘤学临床试验相关的心理社会负担。对回答进行了定性和定量分析。
患者和照顾者都报告了类似主题，确定了与参与1期临床试验相关的负担和益处。然而，照顾者表达的负担超过了患者，证实了该研究的假设。
确定了不仅需要为患者而且需要为照顾者持续提供额外支持服务。
