Trimbos-institute, Netherlands Institute of Mental Health and Addiction, Da Costakade 45, 3521, VS, Utrecht, The Netherlands.
Utrecht University, Domplein 29, 3512, JE, Utrecht, The Netherlands.
BMC Cancer. 2018 Apr 2;18(1):364. doi: 10.1186/s12885-018-4206-z.
Brief interventions for smoking cessation and alcohol moderation may contribute considerably to the prevention of cancer among populations at risk, such as cancer survivors, in addition to improving their general wellbeing. There is accumulating evidence for the effectiveness of internet-based brief health behaviour interventions. The objective of this study is to assess the effectiveness, patient-level cost-effectiveness and cost-utility of two new online theory-based self-help interventions among adult cancer survivors in the Netherlands. One of the interventions focuses on alcohol moderation, the other on smoking cessation. Both interventions are tailored to cancer survivors.
Effectiveness will be assessed in two separate, nearly identical 2-armed RCTs: alcohol moderation (AM RCT) and smoking cessation (SC RCT). Participants are randomly allocated to either the intervention groups or the control groups. In the intervention groups, participants have access to one of the newly developed interventions. In the control groups, participants receive an online static information brochure on alcohol (AM RCT) or smoking (SC RCT). Main study outcome parameters are the number of drinks post-randomisation (AM RCT) and tobacco abstinence (SC RCT). In addition, cost-data and possible effect moderators and mediators will be assessed. Both treatments are internet-based minimally guided self-help interventions: MyCourse - Moderate Drinking (in Dutch: MijnKoers - Minderen met Drinken) and MyCourse - Quit Smoking (MijnKoers - Stoppen met Roken). They are based on cognitive behaviour therapy (CBT), motivational interviewing (MI) and acceptance and commitment therapy (ACT). Both interventions are optimized in collaboration with the target population of cancer survivors in focus groups and interviews, and in collaboration with several experts on eHealth, smoking cessation, alcohol misuse and cancer survivorship.
The present study will add to scientific knowledge on the (cost-)effectiveness of internet-based self-help interventions to aid in smoking cessation or alcohol moderation, working mechanisms and impact on quality of life of cancer survivors. If found effective, these interventions can contribute to providing evidence-based psychosocial oncology care to a growing population of cancer survivors.
Trials are prospectively registered in The Netherlands Trial Register (NTR): NTR6011 (SC RCT), NTR6010 (AM RCT) on 1 September 2016.
简短的戒烟和适度饮酒干预措施可能会大大有助于预防高危人群(如癌症幸存者)的癌症,同时提高他们的整体健康水平。越来越多的证据表明基于互联网的简短健康行为干预措施是有效的。本研究的目的是评估两种新的基于在线理论的自助干预措施在荷兰成年癌症幸存者中的有效性、患者层面的成本效益和成本效用。其中一种干预措施侧重于适度饮酒,另一种侧重于戒烟。这两种干预措施都是针对癌症幸存者量身定制的。
将在两项独立的、几乎相同的 2 臂 RCT 中评估有效性:酒精适度干预(AM RCT)和戒烟干预(SC RCT)。参与者被随机分配到干预组或对照组。在干预组中,参与者可以访问新开发的干预措施之一。在对照组中,参与者会收到有关酒精(AM RCT)或吸烟(SC RCT)的在线静态信息手册。主要研究结果参数是随机分组后的饮酒量(AM RCT)和烟草戒断(SC RCT)。此外,还将评估成本数据以及可能的效果调节剂和中介因素。两种治疗均为基于互联网的最小指导自助干预:MyCourse-适度饮酒(荷兰语:MijnKoers-Minderen met Drinken)和 MyCourse-戒烟(MijnKoers-Stoppen met Roken)。它们基于认知行为疗法(CBT)、动机访谈(MI)和接受与承诺疗法(ACT)。这两种干预措施都是与关注的癌症幸存者群体在焦点小组和访谈中合作优化的,并与几位电子健康、戒烟、酒精滥用和癌症生存专家合作优化的。
本研究将增加有关基于互联网的自助干预措施在戒烟或适度饮酒方面的有效性、作用机制和对癌症幸存者生活质量影响的科学知识。如果发现有效,这些干预措施可以为不断增长的癌症幸存者群体提供基于证据的心理肿瘤学护理。
试验于 2016 年 9 月 1 日在荷兰试验注册处(NTR)前瞻性注册:NTR6011(SC RCT),NTR6010(AM RCT)。