School of Medicine and Public Health, College of Health, Medicine and Wellbeing, The University of Newcastle, Callaghan, New South Wales, Australia
School of Medicine and Public Health, College of Health, Medicine and Wellbeing, The University of Newcastle, Callaghan, New South Wales, Australia.
BMJ Open. 2022 Dec 7;12(12):e062467. doi: 10.1136/bmjopen-2022-062467.
Patients undergoing treatment for cancer who require radiation therapy (RT) report anxiety specifically relating to the RT procedure. Procedural anxiety can be detrimental to treatment delivery, causing disruptions to treatment sessions, or treatment avoidance. Acute procedural anxiety is most commonly managed with anxiolytic medication. There is a need for effective, non-pharmacological interventions for patients not suitable for, or who prefer to avoid, anxiolytic medication. The primary objectives of this pilot trial are to evaluate the: (1) feasibility of conducting the Biofeedback Enabled CALM (BeCALM) intervention during RT treatment sessions; (2) acceptability of the BeCALM intervention among patients; and (3) acceptability of the BeCALM intervention among radiation therapists. The secondary objective of this pilot trial is to examine the potential effectiveness of the BeCALM intervention delivered by radiation therapists to reduce procedural anxiety during RT.
This is a pilot randomised controlled trial. A researcher will recruit adult patients with cancer (3-month recruitment period) scheduled to undergo RT and meeting eligibility criteria for procedural anxiety at the Calvary Mater Hospital, Newcastle (NSW), Australia. Participants will be randomly assigned to receive treatment as usual or the BeCALM intervention (biofeedback plus brief breathing techniques). The primary outcomes are feasibility (measured by recruitment, retention rates and percentage of treatment sessions in which the intervention was successfully delivered); radiation therapists perceived feasibility and acceptability (survey responses); and patient perceived acceptability (survey responses). Secondary outcome is potential effectiveness of the intervention (as measured by the State Trait Anxiety Inventory-State subscale; the Distress Thermometer; and an analysis of treatment duration).
The study protocol has received approval from Hunter New England Health Human Research Ethics Committee (2021/ETH11356). The results will be disseminated via peer-reviewed publications, as well as presentation at relevant conferences.
ACTRN12621001742864.
接受放射治疗 (RT) 的癌症患者报告称，他们对 RT 过程存在特定的焦虑。程序性焦虑会对治疗的实施造成损害，导致治疗中断或治疗回避。急性程序性焦虑最常通过使用抗焦虑药物来治疗。对于不适合或不愿使用抗焦虑药物的患者，需要有效的非药物干预措施。本试验的主要目的是评估：(1) 在 RT 治疗过程中实施生物反馈增强 CALM (BeCALM) 干预的可行性；(2) 该干预措施在患者中的可接受性；以及 (3) 放射治疗师对该干预措施的可接受性。本试验的次要目的是研究由放射治疗师提供的 BeCALM 干预措施在降低 RT 过程中的程序性焦虑方面的潜在有效性。
这是一项试点随机对照试验。研究人员将在澳大利亚新南威尔士州卡拉瓦 Mater 医院招募接受 RT 治疗且符合程序性焦虑标准的成年癌症患者（为期 3 个月的招募期）。参与者将被随机分配接受常规治疗或 BeCALM 干预（生物反馈加简短呼吸技术）。主要结局指标是可行性（通过招募、保留率和干预措施成功实施的治疗次数百分比来衡量）；放射治疗师感知的可行性和可接受性（通过调查答复）；以及患者感知的可接受性（通过调查答复）。次要结局是干预措施的潜在有效性（通过状态特质焦虑量表状态分量表、痛苦温度计和治疗持续时间分析来衡量）。
该研究方案已获得亨特新英格兰卫生人体研究伦理委员会的批准（2021/ETH11356）。研究结果将通过同行评审的出版物以及在相关会议上的报告进行传播。
ACTRN12621001742864。
