Carlson Linda E, Zelinski Erin L, Speca Michael, Balneaves Lynda G, Jones Jennifer M, Santa Mina Daniel, Wayne Peter M, Campbell Tavis S, Giese-Davis Janine, Faris Peter, Zwicker Jennifer, Patel Kamala, Beattie Tara L, Cole Steve, Toivonen Kirsti, Nation Jill, Peng Philip, Thong Bruce, Wong Raimond, Vohra Sunita
Department of Oncology, University of Calgary, Calgary, AB, Canada; Cancer Control Board, Alberta Health Services, AB, Canada.
Department of Oncology, University of Calgary, Calgary, AB, Canada; Cancer Control Board, Alberta Health Services, AB, Canada.
Contemp Clin Trials. 2017 Aug;59:64-76. doi: 10.1016/j.cct.2017.05.015. Epub 2017 May 30.
A growing number of cancer survivors suffer high levels of distress, depression and stress, as well as sleep disturbance, pain and fatigue. Two different mind-body interventions helpful for treating these problems are Mindfulness-Based Cancer Recovery (MBCR) and Tai Chi/Qigong (TCQ). However, while both interventions show efficacy compared to usual care, they have never been evaluated in the same study or directly compared. This study will be the first to incorporate innovative design features including patient choice while evaluating two interventions to treat distressed cancer survivors. It will also allow for secondary analyses of which program best targets specific symptoms in particular groups of survivors, based on preferences and baseline characteristics.
The design is a preference-based multi-site randomized comparative effectiveness trial. Participants (N=600) with a preference for either MBCR or TCQ will receive their preferred intervention; while those without a preference will be randomized into either intervention. Further, within the preference and non-preference groups, participants will be randomized into immediate intervention or wait-list control. Total mood disturbance on the Profile of mood states (POMS) post-intervention is the primary outcome. Other measures taken pre- and post-intervention and at 6-month follow-up include quality of life, psychological functioning, cancer-related symptoms and physical functioning. Exploratory analyses investigate biomarkers (cortisol, cytokines, blood pressure/Heart Rate Variability, telomere length, gene expression), which may uncover potentially important effects on key biological regulatory and antineoplastic functions. Health economic measures will determine potential savings to the health system.
越来越多的癌症幸存者承受着高度的痛苦、抑郁和压力,以及睡眠障碍、疼痛和疲劳。两种有助于治疗这些问题的身心干预方法分别是基于正念的癌症康复(MBCR)和太极拳/气功(TCQ)。然而,虽然与常规护理相比,这两种干预方法都显示出疗效,但它们从未在同一研究中进行过评估,也没有直接比较过。本研究将首次在评估两种治疗痛苦癌症幸存者的干预措施时纳入创新设计特点,包括患者选择。这也将允许基于偏好和基线特征对哪个项目最能针对特定幸存者群体的特定症状进行二次分析。
该设计是一项基于偏好的多中心随机对照有效性试验。对MBCR或TCQ有偏好的参与者(N = 600)将接受他们喜欢的干预措施;而那些没有偏好的参与者将被随机分配到任何一种干预措施中。此外,在有偏好和无偏好的组中,参与者将被随机分为立即干预组或等待名单对照组。干预后情绪状态量表(POMS)上的总情绪困扰是主要结果。干预前后以及6个月随访时采取的其他测量指标包括生活质量、心理功能、癌症相关症状和身体功能。探索性分析研究生物标志物(皮质醇、细胞因子、血压/心率变异性、端粒长度、基因表达),这可能揭示对关键生物调节和抗肿瘤功能的潜在重要影响。卫生经济措施将确定对卫生系统的潜在节省。