Psychology Service, Portuguese Oncology Institute of Porto (IPOP), Rua Dr. António Bernardino de Almeida, 4200-072, Porto, Portugal.
Cancer Genetics Group, Research Centre of Portuguese Oncology Institute of Porto (CI-IPOP), Rua Dr. António Bernardino de Almeida, 4200-072, Porto, Portugal.
Trials. 2022 Feb 5;23(1):118. doi: 10.1186/s13063-022-06045-x.
Mindfulness-based interventions (MBIs) have been used in oncology contexts as a promising tool with numerous benefits for various health-related and psychosocial outcomes. Despite the increasing popularity of MBIs, few randomized controlled trials (RCTs) have examined their effects upon biological parameters. Specifically, no previous study has examined the effects of MBIs on extracellular vesicles (EVs), which are potentially important markers of health, disease, and stress. Moreover, the lack of RCTs is even more limited within the context of technology-mediated MBIs and long-term effects.
The current study protocol presents a two-arm, parallel, randomized controlled study investigating the effects of internet-supported mindfulness-based cognitive therapy (MBCT) compared with treatment as usual (TAU). Primary outcomes are psychological distress and EV cargo of distressed participants with previous breast, colorectal, or prostate cancer diagnoses. Secondary outcomes are self-reported psychosocial and health-related measures, and additional biological markers. Outcomes will be assessed at baseline, 4 weeks after baseline (mid-point of the intervention), 8 weeks after baseline (immediately post-intervention), 24 weeks after baseline (after booster sessions), and 52 weeks after baseline. Our goal is to recruit at least 111 participants who have been diagnosed with breast, prostate, or colorectal cancer (cancer stage I to III), are between 18 and 65 years old, and have had primary cancer treatments completed between 3 months and 5 years ago. Half of the participants will be randomized to the TAU group, and the other half will participate in an 8-week online MBCT intervention with weekly group sessions via videoconference. The intervention also includes asynchronous homework, an online retreat after the fifth week, and 4 monthly booster sessions after completion of the 8-week programme.
This study will allow characterizing the effects of internet-based MBCT on psychosocial and biological indicators in the context of cancer. The effects on circulating EVs will also be investigated, as a possible neurobiological pathway underlying mind-body intervention effects.
ClinicalTrials.gov NCT04727593 (date of registration: 27 January 2021; date of record verification: 6 October 2021).
基于正念的干预（MBIs）已在肿瘤学领域被用作一种有前途的工具，对各种与健康相关和心理社会结果具有众多益处。尽管 MBIs 的普及程度不断提高，但很少有随机对照试验（RCT）研究其对生物学参数的影响。具体来说，以前没有研究检查过 MBIs 对细胞外囊泡（EVs）的影响，EVs 是健康、疾病和压力的潜在重要标志物。此外，在技术介导的 MBIs 和长期效果的背景下，RCT 甚至更为有限。
本研究方案介绍了一项双臂、平行、随机对照研究，旨在调查互联网支持的正念认知疗法（MBCT）与常规治疗（TAU）相比的效果。主要结局是有先前乳腺癌、结直肠癌或前列腺癌诊断的心理困扰和 EV 负荷的受困扰参与者。次要结局是自我报告的心理社会和健康相关措施以及其他生物学标志物。结局将在基线、基线后 4 周（干预的中点）、基线后 8 周（干预后立即）、基线后 24 周（在强化课程后）和基线后 52 周进行评估。我们的目标是招募至少 111 名参与者，他们被诊断患有乳腺癌、前列腺癌或结直肠癌（I 期至 III 期），年龄在 18 至 65 岁之间，且在 3 个月至 5 年前完成了主要癌症治疗。一半的参与者将被随机分配到 TAU 组，另一半将参加为期 8 周的在线 MBCT 干预，每周通过视频会议进行小组会议。该干预还包括异步作业、第五周后的在线静修以及完成 8 周计划后的 4 次月度强化课程。
这项研究将能够描述基于互联网的 MBCT 在癌症背景下对心理社会和生物学指标的影响。还将研究循环 EVs 的影响，作为身心干预效果的潜在神经生物学途径。
ClinicalTrials.gov NCT04727593（注册日期：2021 年 1 月 27 日；记录验证日期：2021 年 10 月 6 日）。
