The modulatory role of internet-supported mindfulness-based cognitive therapy on extracellular vesicles and psychological distress in people who have had cancer: a protocol for a two-armed randomized controlled study

Trials

M. Goreti F. Sales¹  Ricardo João Teixeira²  Rita Calisto³  Linda E. Carlson⁴  Genevieve Bart⁵  Seppo J. Vainio⁵  Diana R. Pereira⁶  Eunice R. Silva⁶  Rui Henrique⁷  Carmen Jerónimo⁷  Carina Carvalho-Maia⁷  Catarina Lourenço⁷  Sara Monteiro-Reis⁷ 

[1] BioMark@UC, Department of Chemical Engineering, Faculty of Sciences and Technology, University of Coimbra;CINEICC, Faculty of Psychology and Educational Sciences, University of Coimbra;Cancer Epidemiology Group-Research Center, Portuguese Oncology Institute of Porto (IPOP);Department of Oncology, University of Calgary;Disease Networks Research Unit, Laboratory of Developmental Biology, Faculty of Biochemistry and Molecular Medicine, Infotech Oulu, Kvantum Institute, University of Oulu;Psychology Service, Portuguese Oncology Institute of Porto (IPOP);RISE@CI-IPOP (Health Research Network), Portuguese Oncology Institute of Porto (IPOP);

关键词: Cancer;    Distress;    Extracellular vesicles;    Internet;    Online;    Mindfulness-based cognitive therapy;   

DOI  :  10.1186/s13063-022-06045-x

来源: DOAJ

【 摘 要 】

Abstract Background 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. Methods 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. Discussion 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. Trial registration ClinicalTrials.gov NCT04727593 (date of registration: 27 January 2021; date of record verification: 6 October 2021).

【 授权许可】

Unknown