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

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.govNCT04727593 (date of registration: 27 January 2021; date of record verification: 6 October 2021).

The efficacy of cognitive behavioral therapy for cancer: A scientometric analysis

“…The article "The modulatory role of internet-supported MBCT on extracellular vesicles and psychological distress in people who have had cancer: a protocol for a twoarmed randomized controlled study" written by Pereira et al and can therefore be used for cancer screening and diagnosis. The authors evaluated the concentration of biochemical markers in the blood of the body, such as interleukin, tumor necrosis factor, C-reactive protein, etc., telomerase activity, which is a marker related to cancer recovery, and cancerrelated antigens, and then detected the impact of MBCT intervention on the overall immune response, finally measured the changes of extracellular vesicles in the central nervous system (50). This article started with the substances that promote the growth and metastasis of cancer, analyzed whether psychological intervention measures can affect the changes of these substances, and then revealed some potential molecular mechanisms of psychological intervention in cancer treatment.…”

“…The article “The modulatory role of internet-supported MBCT on extracellular vesicles and psychological distress in people who have had cancer: a protocol for a two-armed randomized controlled study” written by Pereira et al ( 50 ) was an important milestone in the development of molecular mechanisms in this field ( 50 ). It revealed the possible molecular mechanisms by which psychological interventions can improve cancer prognosis.…”