Barrera Maru, Desjardins Leandra, Prasad Soni, Shama Wendy, Alexander Sarah, Szatmari Peter, Hancock Kelly
Division of Hematology/Oncology, Department of Psychology, SickKids Hospital, Toronto, Ontario, Canada.
Cancer Axis, Research Centre, Sainte-Justine University Health Centre, Montreal, Quebec, Canada.
Psychooncology. 2022 May;31(5):735-744. doi: 10.1002/pon.5857. Epub 2021 Nov 23.
Psychosocial screening is a standard of care in pediatric oncology, but there is limited information about how to intervene after screening. This pilot trial aimed to determine feasibility of the novel Enhanced Psychosocial Screening Intervention (EPSI) and explore its preliminary efficacy outcomes. We examined rates of recruitment, retention, intervention acceptability, and monthly distress screening completion, as well as exploratory efficacy outcomes (Patient-Reported Outcomes Measurement Information System: depression, anxiety and fatigue; distress thermometer, pain and sleep).
Parallel-group randomized pilot trial: Caregiver-youth (10-17 years at enrollment, newly diagnosed with cancer) dyads were randomly allocated to either EPSI or standard care with 1:1 ratio allocation. EPSI consists of having a Psychosocial Navigator who shares screening results conducted near diagnosis and monthly for one year with treating teams and families, and provides recommendations tailored to screening results.
Enrollment rate was 54% (38 dyads); retention was 90% and acceptability 86% (caregivers) and 76% (youth). Exploratory symptoms of depression, anxiety, distress and fatigue outcomes consistently improved mainly for caregivers.
Results suggest EPSI is feasible and acceptable and exploratory mental and physical efficacy outcomes are promising for use in a future confirmatory multisite efficacy trial.
心理社会筛查是儿科肿瘤学护理的一项标准,但关于筛查后如何进行干预的信息有限。这项试点试验旨在确定新型强化心理社会筛查干预措施(EPSI)的可行性,并探索其初步疗效结果。我们研究了招募率、留存率、干预可接受性、每月痛苦筛查完成率,以及探索性疗效结果(患者报告结果测量信息系统:抑郁、焦虑和疲劳;痛苦温度计、疼痛和睡眠)。
平行组随机试点试验:照顾者-青少年(入组时年龄为10-17岁,新诊断为癌症)二元组按1:1的比例随机分配到EPSI组或标准护理组。EPSI包括由一名心理社会导航员与治疗团队和家庭分享在诊断时及之后一年内每月进行的筛查结果,并根据筛查结果提供针对性建议。
招募率为54%(38个二元组);留存率为90%,照顾者的干预可接受性为86%,青少年为76%。抑郁、焦虑、痛苦和疲劳的探索性症状结果主要在照顾者中持续改善。
结果表明EPSI是可行且可接受的,探索性的心理和生理疗效结果有望用于未来的多中心疗效验证试验。