Cancer and Palliative Care Outcomes Centre, School of Nursing, Queensland University of Technology, 60 Musk Avenue, Kelvin Grove, QLD, 4059, Brisbane, Australia.
Centre for Children's Health Research, Children's Health Queensland Hospital and Health Service, Queensland Children's Hospital, 62 Graham St, South Brisbane, QLD, 4101, Brisbane, Australia.
BMC Health Serv Res. 2021 Sep 9;21(1):942. doi: 10.1186/s12913-021-06943-x.
Intense and aggressive treatment regimens for most children's cancer have achieved vast improvements in survival but are also responsible for both a high number and burden of symptoms. The use of Patient Reported Outcome Measures (PROMs) demonstrates a range of benefits for improved symptom management in adults with cancer. There are, however, multiple barriers to integrating PROMs into routine care in children and adolescents with cancer. This study aims to evaluate: (1) the effectiveness of electronic PROMs to generate stratified alerts, symptom management recommendations and graphical summaries (the RESPONSE system) to improve health outcomes and (2) the implementation of the RESPONSE system by assessing feasibility, acceptability, satisfaction, and sustainability.
A pragmatic hybrid II effectiveness-implementation controlled trial, using mixed methods, will be undertaken, advancing both knowledge of the effectiveness of the intervention and implementation factors. One-hundred and sixty children with cancer receiving active treatment will be recruited 1:1 to a non-randomised study involving two groups with an equal number of participants in each group. The intervention group (n = 80) will be prospectively recruited to receive the RESPONSE system intervention over eight weeks, versus the historical matched control group (n = 80) who will complete the ePROMs without access to the RESPONSE system. The primary outcome of the effectiveness trial is change between groups in total symptom burden. Secondary outcomes include child health-related quality-of-life and implementation outcomes. Trial data will be analysed using linear mixed-effects models. Formative implementation evaluation is informed by CFIR and ERIC frameworks and implementation outcomes will be mapped to the RE-AIM framework and include interviews, field notes, as well as administrative data to evaluate feasibility, acceptability, satisfaction and sustainability.
ACTRN12621001084875 . Retrospectively Registered 16 August 2021.
大多数儿童癌症的强化和积极治疗方案在提高生存率方面取得了巨大进展，但也导致了大量症状的出现和负担。使用患者报告的结局测量（PROMs）为改善癌症成人的症状管理提供了一系列益处。然而，将 PROMs 整合到儿童和青少年癌症的常规护理中存在多种障碍。本研究旨在评估：（1）电子 PROMs 生成分层警报、症状管理建议和图形摘要（RESPONSE 系统）以改善健康结果的有效性，以及（2）通过评估可行性、可接受性、满意度和可持续性来评估 RESPONSE 系统的实施情况。
将进行一项实用的混合 II 有效性-实施控制试验，采用混合方法，既推进干预措施的有效性知识，又推进实施因素知识。将招募 160 名接受积极治疗的癌症儿童，以 1:1 的比例进行非随机研究，每组有相等数量的参与者。干预组（n=80）将前瞻性地招募接受 RESPONSE 系统干预 8 周，而历史匹配的对照组（n=80）将在没有获得 RESPONSE 系统的情况下完成电子 PROMs。有效性试验的主要结果是两组之间总症状负担的变化。次要结果包括儿童健康相关生活质量和实施结果。试验数据将使用线性混合效应模型进行分析。形成性实施评估以 CFIR 和 ERIC 框架为依据，实施结果将映射到 RE-AIM 框架，包括访谈、现场记录以及行政数据，以评估可行性、可接受性、满意度和可持续性。
ACTRN12621001084875。2021 年 8 月 16 日回顾性注册。
