Russell Lahiru, Ugalde Anna, Milne Donna, Krishnasamy Meinir, O Seung Chul Eric, Austin David W, Chambers Richard, Orellana Liliana, Livingston Patricia M
Deakin University, School of Nursing and Midwifery, Faculty of Health, Geelong, Australia.
Skin and Melanoma Services/Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, Melbourne, Australia.
Trials. 2018 Apr 13;19(1):223. doi: 10.1186/s13063-018-2575-x.
People with a melanoma diagnosis are at risk of recurrence, developing a new primary or experiencing disease progression. Previous studies have suggested that fear of a cancer recurrence is clinically relevant in this group of patients and, if not addressed, can lead to distress. Mindfulness-based interventions have been shown to alleviate symptoms of anxiety and depression among various groups of cancer patients. Online mindfulness-based interventions have the potential to reach people unable to attend face-to-face interventions due to limitations such as cancer-related illness, transportation or time constraints. This study aims to (1) examine whether individuals with a melanoma diagnosis are willing to participate and adhere to a 6-week online mindfulness-based intervention and (2) explore potential benefits of the program on fear of cancer recurrence, worries, rumination, perceived stress and trait mindfulness to inform the design of a clinical trial.
METHODS/DESIGN: This is a single-site randomised controlled trial of a feasibility study. Seventy-five participants with stage 2c or 3 melanoma will be recruited from a melanoma outpatient clinic and randomised (2:1) either to an online mindfulness-based program (intervention) or to usual care (control). The intervention is a 6-week program specifically developed for this study. It consists of videos describing the concept of mindfulness, short daily guided meditation practices (5-10 min), automated meditation reminders and instructions for applying mindfulness in daily life to enhance wellbeing. All participants will complete questionnaires at baseline and at 6-week post-randomisation. Participants in the control group will be given access to the online program at the end of the study. Primary outcomes are overall recruitment; retention; extent of questionnaire completion; and usability and acceptability of, and adherence to, the program. The secondary outcomes are fear of cancer recurrence, worries, rumination, perceived stress and trait mindfulness measured using validated instruments.
This feasibility study will evaluate participants' satisfaction with the program and identify barriers to recruitment and adherence. The recruitment and data collection process will highlight methodological aspects to address in the planning of a larger scale study assessing the impact of an online mindfulness-based intervention on fear of cancer recurrence and wellbeing.
Australian New Zealand Clinical Trials Registry, ACTRN12617000081314 . Registered on 16 January 2017.
被诊断为黑色素瘤的患者有复发、出现新的原发性肿瘤或疾病进展的风险。先前的研究表明，对癌症复发的恐惧在这类患者中具有临床相关性，若不加以解决，可能会导致痛苦。基于正念的干预措施已被证明可减轻各类癌症患者的焦虑和抑郁症状。基于正念的在线干预措施有可能惠及那些因癌症相关疾病、交通或时间限制等因素而无法参加面对面干预的人群。本研究旨在：（1）调查被诊断为黑色素瘤的个体是否愿意参与并坚持为期6周的基于正念的在线干预；（2）探索该项目对癌症复发恐惧、担忧、沉思、感知压力和特质正念的潜在益处，以为一项临床试验的设计提供参考。
方法/设计：这是一项可行性研究的单中心随机对照试验。将从一家黑色素瘤门诊招募75名2c期或3期黑色素瘤患者，并随机（2:1）分为基于正念的在线项目组（干预组）或常规护理组（对照组）。干预是一项专门为本研究开发的为期6周的项目。它包括描述正念概念的视频、每日简短的引导冥想练习（5 - 10分钟）、自动冥想提醒以及在日常生活中应用正念以增进幸福感的指导。所有参与者将在基线和随机分组后6周完成问卷调查。对照组的参与者将在研究结束时获得在线项目的访问权限。主要结局指标包括总体招募情况；留存率；问卷完成程度；以及该项目的可用性、可接受性和依从性。次要结局指标是使用经过验证的工具测量的癌症复发恐惧、担忧、沉思、感知压力和特质正念。
这项可行性研究将评估参与者对该项目的满意度，并确定招募和依从方面的障碍。招募和数据收集过程将突出在规划一项评估基于正念的在线干预对癌症复发恐惧和幸福感影响的更大规模研究时需要解决的方法学问题。
澳大利亚新西兰临床试验注册中心，ACTRN12617000081314。于2017年1月16日注册。
